clinical data update system (cdus) v3.0 notice of modifications
TRANSCRIPT
Clinical Data Update System (CDUS) v3.0 Notice of Modifications May 3, 2002
NCI CTEP Help Desk - Telephone: (301) 840-8202 Fax: (301) 948-2242 E-mail: [email protected]
CTIS
Building The Future
T O G E T H E RTM
By Capital Technology Information Services, Inc.
CTEP Home Page: http://ctep.cancer.gov/ i May 3, 2002
TABLE OF CONTENTS Updates and Clarifications made to the January 28, 2002 Notice of Modifications............................iii SECTION 1: New Information to be Collected – Changes to Existing Tables.......................................1
1.1 COLLECTIONS TABLE ............................................................................................................................... 1 1.1.1 Current Trial Status Date.................................................................................................................. 1 1.1.2 Technical Reporting Requirements .................................................................................................. 1
1.2 CORRELATIVE_STUDIES TABLE ............................................................................................................ 2 1.2.1 Number of Samples Collected.......................................................................................................... 2 1.2.2 Number of Samples Analyzed.......................................................................................................... 2 1.2.3 Technical Reporting Requirements .................................................................................................. 2
1.3 PATIENTS TABLE........................................................................................................................................ 2 1.3.1 Ethnicity Flag ................................................................................................................................... 2 1.3.2 Date of Last Treatment..................................................................................................................... 3 1.3.3 Off Study Reason ............................................................................................................................. 3 1.3.4 Off Study Date.................................................................................................................................. 4 1.3.5 Baseline Abnormalities Flag ............................................................................................................ 4 1.3.6 Race Code ........................................................................................................................................ 4 1.3.7 Eligibility Status ............................................................................................................................... 4 1.3.8 Technical Reporting Requirements .................................................................................................. 4
1.4 TREATMENT_COURSES TABLE .............................................................................................................. 5 1.4.1 Field Name and Attribute Change .................................................................................................... 5
1.5 COURSE_AGENTS TABLE......................................................................................................................... 6 1.5.1 Attribute Change .............................................................................................................................. 6
1.6 ADVERSE_EVENTS TABLE (Formerly The TOXIC_EVENTS Table)..................................................... 6 1.6.1 Table Name Change ......................................................................................................................... 6 1.6.2 Field Name and Attribute Change .................................................................................................... 6 1.6.3 Adverse Event - Other, Specify........................................................................................................ 6 1.6.4 New Reporting Requirement ............................................................................................................ 7 1.6.5 Technical Reporting Requirements .................................................................................................. 7
1.7 TRIAL_COMMENTS Table.......................................................................................................................... 8 1.7.1 Field Name Change .......................................................................................................................... 8
1.8 PHASE1_END_POINT_DLTS Table............................................................................................................ 8 1.8.1 Field Name Change .......................................................................................................................... 8
SECTION 2: New Information to be Collected – New Tables ..................................................................9 2.1 PATIENT_RACES TABLE........................................................................................................................... 9
2.1.1 Multiracial Classification ................................................................................................................. 9 2.1.2 Separation of Race and Ethnicity ................................................................................................... 10 2.1.3 Revised Race Values ...................................................................................................................... 10 2.1.4 Ethnicity Values ............................................................................................................................. 10 2.1.5 Technical Reporting Requirements ................................................................................................ 11
2.2 BASELINE_ABNORMALITIES TABLE................................................................................................... 11 2.2.1 Technical Reporting Requirements ................................................................................................ 11
2.3 LATE_ADVERSE_EVENTS TABLE......................................................................................................... 11 2.3.1 Technical Reporting Requirements ................................................................................................ 12
SECTION 3: CDUS Smart Loader Sample File........................................................................................13 SECTION 4: Value Revisions....................................................................................................................14
4.1 Off_Treatment_Reason from the PATIENTS Table .................................................................................... 14 4.2 Therapy_Code from the PRIOR_THERAPIES Table.................................................................................. 14 4.3 Unit_Code from the COURSE_AGENTS Table.......................................................................................... 14 4.4 Race_Code from the PATIENT_RACES Table and Ethnicity_Flag from the PATIENTS Table ............... 15 4.5 International Medical Terminology (IMT) and Medical Dictionary for Regulatory Activities (MedDRA)
Terminology ................................................................................................................................................. 15
CTEP Home Page: http://ctep.cancer.gov/ ii May 3, 2002
SECTION 5: Changes to Field Attributes ................................................................................................16 5.1 Dose_Amount............................................................................................................................................... 16 5.2 Course_ID..................................................................................................................................................... 16 5.3 Unit_Code..................................................................................................................................................... 16
SECTION 6: New and/or Revised Business Rules .................................................................................17 6.1 New and Revised Business Rules (Already Implemented)........................................................................... 17 6.2 New and Revised Business Rules (for Implementation in v3.0)................................................................... 18 6.3 Business Rules where a Warning will change to a Caution (for Implementation in April 2002) ................. 20
SECTION 7: Clarifications/New Instructions for Data Submissions ....................................................21 7.1 Response Information................................................................................................................................... 21 7.2 TREATMENT_COURSES Table, AE_Experienced Flag ........................................................................... 21 7.3 Subgroup, Treatment Assignment Codes and Correlative Study IDs and Descriptions ............................... 21 7.4 Smart Loader Reminder, Warning, and Suspension Process ........................................................................ 21 7.5 Reference Removed...................................................................................................................................... 22 7.6 Registering Group ID ................................................................................................................................... 22 7.7 Registering Institution ID ............................................................................................................................. 22 7.8 Phase I End Points ........................................................................................................................................ 22
Appendix A: Summary List of Modifications........................................................................................A-1
CTEP Home Page: http://ctep.cancer.gov/ iii May 3, 2002
Updates and Clarifications Made to the January 28, 2002 Notice of Modifications Funding Information All references to the collection of funding information were removed. This includes references made to the Current_Funding_Flag in the COLLECTIONS and CORRELATIVE_STUDY tables, the PROTOCOL_FUNDING and CORRELATIVE_FUNDING tables, the CDUS Smart Loader Sample File, the New and/or Revised Business Rules, and the Summary. The following provides the specific sections affected in the January 28, 2002 Notice of Modifications and the type of revision.
Original Section Name and Number Revision 1.1.2 Current Funding Flag Removed 1.2.1 Current Funding Flag Removed 2.4 PROTOCOL_FUNDING_TABLE Removed 2.5 CORRELATIVE_FUNDING_TABLE Removed 3 CDUS Smart Loader Sample File Revised 6 New and/or Revised Business Rules Revised Appendix A: Summary List of Modifications Revised
Clarifications and Editorial Modifications 1.3.3 Off Study Date and 1.3.4 Off Study Reason, pg. 4: These sections were switched to reflect their placement within the PATIENTS Table (the sections are now numbered 1.3.3 Off Study Reason and 1.3.4 Off Study Date). 1.4 TREATMENT_COURSES TABLE, pg. 6: The word “Table” appearing first in the section title was removed. 1.6.3 Adverse Event - Other, Specify, pg. 7: Minor typographical revisions were made for consistency.
2.2. BASELINE_ABNORMALITIES TABLE, pg. 12: The word “toxicities” was changed to “Adverse Events” in the following sentence: Baseline abnormality information will provide CTEP with a baseline to use when analyzing treatment-related toxicities.
4.1 OFF TREATMENT REASON, pg. 16: This section title was renamed to reflect both the field and table name (the section is now named OFF_TREATMENT_REASON FROM THE PATIENTS TABLE). 4.1 OFF TREATMENT REASON, pg. 16: The new and removed values were formatted as columns to be consistent with Sections 4.2 and 4.3.
4.2 PRIOR THERAPIES, pg. 16: This section title was renamed to reflect both the field and table name (the section is now named THERAPY_CODE FROM THE PRIOR_THERAPIES TABLE). 4.3 DOSE UNIT CODE, pg. 16: This section title was renamed to reflect both the field and table name (the section is now named UNIT_CODE FROM THE COURSE_AGENTS TABLE). The value “mVP” was updated to “MVP.”
4.4 PATIENT RACE AND PATIENT ETHNICITY, pg. 17: This section title was renamed to reflect both the field and table name (the section is now named RACE_CODE FROM THE PATIENT RACES TABLE AND ETHNICITY_FLAG FROM THE PATIENTS TABLE). 4.5 INTERNATIONAL MEDICAL TERMINOLOGY (IMT) AND MEDICAL DICTIONARY FOR REGULATORY ACTIVITIES (MedDRA) TERMINOLOGY, pg. 17: This section was updated to specify the field names and tables affected by the change from IMT to MedDRA codes.
4.4 PATIENT RACE AND PATIENT ETHNICITY, pg. 17: The Hispanic Race Code was updated from (2) to (02). 5.1 DOSE_AMOUNT, pg. 18: This section was updated to clarify that the total number of spaces available for entry as 20. If needed, 17 spaces can be used for digits with an additional three spaces available for decimal places.
Updates to Section 1: New Information to be Collected – Changes to Existing Tables 1.3.3 Off Study Reason, pg. 4: The word “period” was removed from the following valid value description: 01 = Protocol-defined follow-up period completed
CTEP Home Page: http://ctep.cancer.gov/ iv May 3, 2002
1.3.3 Off Study Reason, pg. 4: The word “toxicity” was replaced with “Adverse Event” for the following valid value description: 05 = Toxicity/Side Effects/Complications
1.3.3 Off Study Reason, pg. 4: “Other” (98) was added to the list of Off_Study_Reason valid values.
1.3.4 Off Study Date, pg. 4: The section was updated to clarify that any value given for Off_Study_Reason would require entry of the Off_Study_Date.
1.3.8 Technical Reporting Requirements, pg. 5: The attribute for the Ethnicity_Flag was updated fromVarchar2(2) to Varchar2(1).
1.4.1 Field Name and Attribute Change, pg. 6: The original field name (Tox_Experience) and the new field name (AE_Experience) were changed to past tense (Tox_Experienced and AE_Experienced). The section was updated to better reflect the change to the Course_ID field.
1.5 COURSE_AGENTS TABLE, pg. 6: The section was updated to better reflect the change to the Course_ID field.
1.6.2 Field Name and Attribute Change, pg. 6: The section was updated to better reflect the change to the Course_ID field.
1.6.3 Adverse Event – Other, Specify, pg. 7: The term “toxicity type” was replaced with “AE_Type_Code” in the following sentence: The AE_Other_Specify field was added to the ADVERSE_EVENTS table to collect the name of the Adverse Event when a toxicity type of 'Other, Specify' is selected.
1.6.5 Technical Reporting Requirements, pg. 8: The placement of the AE_Other_Specify element within the ADVERSE_EVENTS table was modified to group the primary key elements together.
1.6.5 Technical Reporting Requirements, pg. 8: The Course_ID field was updated from “Number6(1)” to “Number(6).”
1.7 TRIAL_COMMENTS TABLE, pg. 8: This section was added to reflect a field name change.
1.8 PHASE1_END_POINT_DLTS TABLE, pg. 8: This section was added to reflect a field name change.
Updates to Section 1: New Information to be Collected – New Tables 2.1.5 Technical Reporting Requirements, pg. 12: The attribute for the Patient_ID column was updated from Varchar2(10) to Varchar2(20).
2.2.1 Technical Reporting Requirements, pg. 12: The placement of AE_Other_Specify element within the BASELINE_ABNORMALITIES table was modified to group the primary key elements together.
2.2.1 Technical Reporting Requirements, pg. 12: The attribute for the Patient_ID column was updated from Varchar2(10) to Varchar2(20).
2.3.1 Technical Reporting Requirements, pg. 13: The placement of AE_Other_Specify element within the LATE_ADVERSE_EVENTS table was modified to group the primary key elements together.
2.3.1 Technical Reporting Requirements, pg. 13: The attribute for the Patient_ID column was updated from Varchar2(10) to Varchar2(20).
Updates to Section 3: CDUS Smart Loader Sample File, pg. 15 The PATIENTS table was updated to reflect a varchar field (with quotation marks) for Off_Study_Reason.
The COURSE_AGENTS table was updated to reflect a number field (without quotation marks) for Course_ID and to reflect the Unit_Code as lower case.
The sample file was updated to reflect the placement changes described above for the ADVERSE_EVENTS, BASELINE_ABNORMALITIES, and LATE_ADVERSE_EVENTS tables.
Several data examples were updated to more accurately reflect “live” data.
Updates to Section 4: Value Revisions, pg. 16 4.1 OFF TREATMENT REASON, pg. 16: The word “toxicity” was changed to “Adverse Event” for the following valid value description: 03 = Toxicity/Side Effects/Complications
4.2 Therapy_Code from the PRIOR_THERAPIES Table, pg. 16: MedDRA v5.0 codes were added to the list of new values.
CTEP Home Page: http://ctep.cancer.gov/ v May 3, 2002
4.3 DOSE UNIT CODE, pg. 16: A value was added to accommodate dose units that are measured as cells.
Updates to Section 5: Changes to Field Attributes, pg. 18 5.2 COURSE_ID, pg. 18: This section was updated to reflect the change of the Course_ID field in the COURSE_AGENTS table as well as the TREATMENT_COURSES and ADVERSE_EVENTS tables. This section was also clarified to provide specific attribute information regarding Course_ID.
5.3 UNIT CODE, pg. 18: The table named in this section was updated to the COURSE_AGENTS table.
Updates to Section 6: New and/or Revised Business Rules, pg. 19 Business rules were updated to more accurately reflect the modifications made to the CDUS v3.0. Please refer to this version of the business rules; all previous versions are now obsolete.
Updates to Section 7: Clarifications/New Instructions for Data Submissions, pg. 24 7.1 RESPONSE INFORMATION, pg. 24, Item a: The word “requested” was changed to “mandatory” in the following sentence: If 'Other' is submitted, it is requested that information about the patient’s response be submitted using the Gen_Response_Comments field as described in detail in the TRIAL_COMMENTS table section of the CDUS Instructions and Guidelines.
7.1 RESPONSE INFORMATION, pg. 24, Item c: The reference to the CDUS Abbreviated monitoring method was removed from the following sentence: The Observed_Date from the BEST_RESPONSES table is mandatory for all CDUS-Complete and CDUS-Abbreviated responses submitted, including Stable Disease.
7.3 SUBGROUP AND TREATMENT ASSIGNMENT CODES AND DESCRIPTIONS, pg. 24: This section was updated to include Correlative Study IDs.
7.4 SMART LOADER REMINDER, WARNING, AND SUSPENSION PROCESS, pg. 24: The word “warning” was removed from the following sentence: The CDU data resubmission timeline was modified for files with rejection or warning errors.
Updates to Appendix A: Summary List of Modifications The summary was updated to reflect all clarifications described in this section. The following identifies specific updates made to the summary that are not reflected in any other section of this document.
CORRELATIVE_STUDIES Table, pg. A-1: A comment as added to clarify that correlative study information is mandatory only for protocols with embedded correlative studies.
PATIENTS Table, pg. A-2, Item 6: The Legacy Data Requirements column was updated to reflect that the Gender_Code field is required for all protocols.
PATIENTS Table, pg. A-2, Item 7: The Legacy Data Requirements column was updated to reflect that the Birth_Date field is required for all protocols. The Comments column was updated to reflect that this is a new reporting requirement.
PATIENTS Table, pg. A-2, Item 9: The column name change was added to the summary.
BASELINE_ABNORMALITIES Table, pg. A-4, Item 7: The Comments column was updated to remove the reference to version 3.0 of the NCI Common Toxicity Criteria (CTC).
Value Revisions, pg. A-5, Item 6: The reference to the NCI Common Toxicity Criteria (CTC), v3.0 was removed. CTEP is currently revising the NCI CTC, however the expected release date is undetermined at this time.
Response Information, pg. A-6, Item 1: The Reporting Requirements and Legacy Data Requirements columns were updated to provide specific requirements for response information.
∗ Italicized items represent those elements that comprise the Primary Key.
CTEP Home Page: http://ctep.cancer.gov/ 1 May 3, 2002
SECTION 1: New Information to be Collected – Changes to Existing Tables
1.1 COLLECTIONS TABLE
1.1.1 Current Trial Status Date The Current_Trial_Status_Date field was added to the COLLECTIONS table to collect the date the current protocol status was effective. For example, if the current status is active, and the protocol became active on January 15, 2000, then 20000115 (format: YYYYMMDD) should be submitted as the status date.
Reporting Requirements: The Current_Trial_Status_Date field is mandatory for all CDUS-Complete and CDUS-Abbreviated studies.
Legacy Data: The Current_Trial_Status_Date field is required for all protocols.
To assist in determining the Current_Trial_Status_Date, CTEP will include the current trial status and current trial status date with each site’s quarterly List of Expected Protocols.
1.1.2 Technical Reporting Requirements Each record associated with the COLLECTIONS table should consist of the following information:*
Protocol_ID Varchar2(35)
Subm_Date Date (YYYYMMDD)
CutOff_Date Date (YYYYMMDD)
Current_Trial_Status_Code Varchar2(2) Current_Trial_Status_Date Date (YYYYMMDD)
Completer_Name1 Varchar2(87)
Completer_Phone Varchar2(20)
Completer_FAX Varchar2(20)
Completer_Email Varchar2(50)
Change_Code Varchar2(1)
A sample record associated with the COLLECTIONS table will appear as follows:
"COLLECTIONS","<Protocol_ID>",<Subm_Date>,<CutOff_Date>,"<Current_Trial_Status_Code>",<Current_Trial_Status_Date>,"<Completer_Name>","<Completer_Phone>","<Completer_FAX>","<Completer_Email>","<Change_Code>"
1 Completer_Name should be submitted in the format Last name^First name^Middle initial (e.g., Public^John^Q). This information will be converted internally by CTEP during the Smart Loader data load into the three separate fields depicted on the data model.
∗ Italicized items represent those elements that comprise the Primary Key.
CTEP Home Page: http://ctep.cancer.gov/ 2 May 3, 2002
1.2 CORRELATIVE_STUDIES TABLE
Note: The reporting requirements for correlative study information were expanded to include protocols assigned to CDUS-Abbreviated reporting (formerly this information was only requested for protocols assigned to CDUS-Complete reporting).
1.2.1 Number of Samples Collected The Samples_Collected field was added to the CORRELATIVE_STUDIES table to collect the number of samples gathered across patients. For example, if three samples were collected for six patients on the correlative study, then 18 samples would be reported.
Reporting Requirements: The Samples_Collected field is mandatory for all CDUS-Complete and CDUS-Abbreviated protocols that have embedded correlative studies.
Legacy Data: Samples_Collected is required only for protocols that were activated on or after January 1, 2002.
1.2.2 Number of Samples Analyzed The Samples_Analyzed field was added to the CORRELATIVE_STUDIES table to collect the number of samples analyzed across patients.
Reporting Requirements: The Samples_Analyzed field is mandatory for all CDUS-Complete and CDUS-Abbreviated protocols that have embedded correlative studies.
Legacy Data: Samples_Analyzed is required only for protocols that were activated on or after January 1, 2002.
1.2.3 Technical Reporting Requirements Each record associated with the CORRELATIVE_STUDIES table should consist of the following information:*
Protocol_ID Varchar2(35)
Correlative_Study_ID Varchar2(10) Patients_Collected Number(6)
Patients_Analyzed Number(6) Samples_Collected Number(6)
Samples_Analyzed Number(6)
Findings Varchar2(2000)
A sample record associated with the CORRELATIVE_STUDIES table will appear as follows:
"CORRELATIVE_STUDIES","<Protocol_ID>","<Correlative_Study_ID>",<Patients_Collected>,<Patients_Analyzed>,<Samples_Collected>,<Samples_Analyzed>,"<Findings>"
1.3 PATIENTS TABLE
1.3.1 Ethnicity Flag In accordance with the new requirements from the Office of Management and Budget, the Ethnicity_Flag was added to the PATIENTS table to collect and identify patients with
∗ Italicized items represent those elements that comprise the Primary Key.
CTEP Home Page: http://ctep.cancer.gov/ 3 May 3, 2002
Hispanic or Latino culture or origin. This is defined as "a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race" (see Section 2.1.4 and the table below for new Ethnicity values). New Patient Ethnicity Codes
CODE DESCRIPTION DEFINITION 1 Hispanic or Latino A person of Cuban, Mexican, Puerto Rican, South or
Central American, or other Spanish culture or origin, regardless of race.
2 Non-Hispanic A person NOT meeting the definition for Hispanic or Latino.
9 Unknown Unknown
Reporting Requirements: The Ethnicity_Flag is mandatory for all CDUS-Complete and CDUS-Abbreviated studies.
Legacy Data: The Ethnicity_Flag is required for all protocols. Race and ethnicity information for protocols approved on or after January 1, 2002, must be both collected and reported according to the new guidelines (see Section 2.1). Data for protocols approved prior to January 1, 2002, must be mapped according to Section 2.1.
1.3.2 Date of Last Treatment The Last_TX_Date field was added to the PATIENTS table to collect the date of the patient’s last treatment. This date is mandatory when the patient is reported as being off protocol treatment (in YYYYMMDD format).
Reporting Requirements: The Last_TX_Date field is mandatory for all CDUS-Complete studies, but is not required for CDUS-Abbreviated studies.
Legacy Data: The Last_TX_Date is required for protocols activated on or after January 1, 2002.
1.3.3 Off Study Reason The Off_Study_Reason field was added to the PATIENTS table to collect the reason that the patient went off study. The valid values for this field are listed below:
01 = Protocol-defined follow-up completed
02 = Patient lost to follow-up
03 = Patient refused follow-up
04 = Death
05 = Adverse Event/Side Effects/Complications
98 = Other
Reporting Requirements: The Off_Study_Reason field is mandatory for all CDUS-Complete studies, but is not required for CDUS-Abbreviated studies.
Legacy Data: The Off_Study_Reason is required for protocols activated on or after January 1, 2002.
∗ Italicized items represent those elements that comprise the Primary Key.
CTEP Home Page: http://ctep.cancer.gov/ 4 May 3, 2002
1.3.4 Off Study Date The Off_Study_Date field was added to the PATIENTS table to collect the date that the patient went off study due to one of the reasons provided from the valid values in Section 1.3.3.
Reporting Requirements: The Off_Study_Date field is mandatory for all CDUS-Complete studies, but is not required for CDUS-Abbreviated studies.
Legacy Data: The Off_Study_Date is required for protocols activated on or after January 1, 2002.
1.3.5 Baseline Abnormalities Flag The Baseline_Abnormalities_Flag was added to the PATIENTS table to indicate whether baseline abnormalities were found during the patient’s initial history and physical examination (see Section 2.2 for additional details). The valid values for this field are (1) Yes, (2) No, and (9) Unknown.
Reporting Requirements: The Baseline_Abnormalities_Flag is mandatory for all CDUS-Complete studies, but is not required for CDUS-Abbreviated studies.
Legacy Data: The Baseline_Abnormalities_Flag is required for protocols activated on or after January 1, 2002.
1.3.6 Race Code The Race_Code field was moved from the PATIENTS table and is now collected through the new PATIENT_RACES table (see Section 2.1 for additional details).
1.3.7 Eligibility Status On review of CDU data, a problem has been noted with the information being submitted for the eligibility status field in the PATIENTS table. It has been identified that some sites have submitted data as if the question were “Has the patient been declared eligible?” rather than “Has the patient been declared ineligible?” which is instructed in the CDUS Instructions and Guidelines version 2.0.
To more clearly reflect what is being collected for this field, the name of this column has been changed from Eligibility_Status to Ineligibility_Status.
CTEP is requesting that all sites review how they have interpreted this question in the past, and make corrections if it has been previously misinterpreted. An evaluation of the data submitted for this field is underway, and individual sites will be contacted to help ensure that the data is corrected.
1.3.8 Technical Reporting Requirements Each record associated with the PATIENTS table should consist of the following information:*
Protocol_ID Varchar2(35)
Patient_ID Varchar2(20)
Zip_Code Varchar2(10)
Country_Code Varchar2(2)
Birth_Date Date (YYYYMM)
∗ Italicized items represent those elements that comprise the Primary Key.
CTEP Home Page: http://ctep.cancer.gov/ 5 May 3, 2002
Gender_Code Varchar2(1)
Race_Code Varchar2(2) [Race_Code now collected through the PATIENT_RACES table]
Ethnicity_Flag Varchar2(1) [valid values = (1) Hispanic or Latino, (2) Non-Hispanic, or (9) Unknown] Method_Of_Payment Varchar2(2)
Date_Of_Entry Date (YYYYMMDD)
Reg_Group_ID Varchar2(6)
Reg_Inst_ID Varchar2(6)
TX_On_Study Varchar2(1)
Off_TX_Reason Varchar2(2) Last_TX_Date Date (YYYYMMDD)
Off_Study_Reason Varchar2(2)
Off_Study_Date Date (YYYYMMDD)
Subgroup_Code Varchar2(10)
Ineligibility_Status Varchar2(1)
Baseline_PS_Code Varchar2(1)
Prior_Chemo_Regs Number(2)
Disease_Code Number(10)
Resp_Eval_Status Varchar2(1) Baseline_Abnormalities_Flag Varchar2(1)
[valid values = (1) Yes, (2) No, or (9) Unknown]
A sample record associated with the PATIENTS table will appear as follows:
"PATIENTS","<Protocol_ID>","<Patient_ID>","<Zip_Code>","<Country_Code>",<Birth_Date>,"<Gender_Code>","<Ethnicity_Flag>","<Method_Of_Payment>",<Date_Of_Entry>,"<Reg_Group_ID>","<Reg_Inst_ID>","<TX_On_Study>","<Off_TX_Reason>",<Last_TX_Date>,"<Off_Study_Reason",<Off_Study_Date>,"<Subgroup_Code>","<Ineligibility_Status>","<Baseline_PS_Code>",<Prior_Chemo_Regs>,<Disease_Code>,"<Resp_Eval_Status>","<Baseline_Abnormalities_Flag>"
1.4 TREATMENT_COURSES TABLE
1.4.1 Field Name and Attribute Change The following field name was changed to be consistent with CTEP terminology.
Original Field Name New Field Name
Tox_Experienced AE_Experienced
The attribute for the Course_ID field was changed to the following (see Section 5.2 for additional information):
∗ Italicized items represent those elements that comprise the Primary Key.
CTEP Home Page: http://ctep.cancer.gov/ 6 May 3, 2002
Original Field Attribute New Field Attribute
Varchar2(10) Number(6)
These are the only changes to this table. All other information in this table remains the same.
1.5 COURSE_AGENTS TABLE
1.5.1 Attribute Change The attribute for the Course_ID field was changed to the following (see Section 5.2 for additional information):
Original Field Attribute New Field Attribute
Varchar2(10) Number(6)
This is the only change to this table. All other information in this table remains the same.
1.6 ADVERSE_EVENTS TABLE (Formerly The TOXIC_EVENTS Table)
1.6.1 Table Name Change The original name of the TOXIC_EVENTS table was changed to the ADVERSE_EVENTS table to be consistent with CTEP terminology.
1.6.2 Field Name and Attribute Change The following field names were changed to be consistent with CTEP terminology:
Original Field Name New Field Name
Tox_Type_Code AE_Type_Code
Tox_Grade_Code AE_Grade_Code
Tox_Attribution_Code AE_Attribution_Code
The attribute for the Course_ID field was changed to the following (see Section 5.2 for additional information):
Original Field Attribute New Field Attribute
Varchar2(10) Number(6)
1.6.3 Adverse Event - Other, Specify Each category in the Common Toxicity Criteria (CTC) has an Other, Specify option for Adverse Events that are not listed in the available Adverse Event criteria (e.g., Gastrointestinal: Other, Specify; Blood/Bone Marrow: Other, Specify; etc.). The AE_Other_Specify field was added to the ADVERSE_EVENTS table to collect the name of the Adverse Event when the AE_Type_Code of 'Other, Specify' is selected. For example, Hyperkeratosis is not a CTC term but is a very specific dermatologic manifestation associated with the use of a specific class of new agents. In this case, 'DERMATOLOGY/SKIN, Other, Specify' is selected and Hyperkeratosis is entered as the actual Adverse Event term in the AE_Other_Specify field. All categories of the CTC allow for such specificity when the appropriate term is not included in the CTC.
∗ Italicized items represent those elements that comprise the Primary Key.
CTEP Home Page: http://ctep.cancer.gov/ 7 May 3, 2002
Reporting Requirements: The AE_Other_Specify field is mandatory for all CDUS-Complete studies, but are not required for CDUS-Abbreviated studies.
Legacy Data: The AE_Other_Specify field is required for protocols activated on or after January 1, 2002.
1.6.4 New Reporting Requirement Grade 3 Adverse Events with an attribution of Unrelated or Unlikely are now required to be reported. This is a new reporting requirement only.
Reporting Requirements: Grade 3 Adverse Event information is mandatory for all CDUS-Complete studies, but are not required for CDUS-Abbreviated studies.
Legacy Data: Grade 3 Adverse Event information is required for protocols activated on or after January 1, 2002.
The revised schema for CDU reporting requirements is as follows: Routine Adverse Event Reporting Guidelines for CDUS
Attribution Grade 1 Grade 2 Grade 3 Grade 4 Grade 5
Unrelated CDUS CDUS CDUS
Unlikely CDUS CDUS CDUS
Possible CDUS CDUS CDUS CDUS CDUS
Probable CDUS CDUS CDUS CDUS CDUS
Definite CDUS CDUS CDUS CDUS CDUS
1.6.5 Technical Reporting Requirements Each record associated with the ADVERSE_EVENTS table should consist of the following information:*
Protocol_ID Varchar2(35)
Patient_ID Varchar2(20)
Course_ID Number(6)
AE_Type_Code Number(10)
AE_Grade_Code Number(1) AE_Other_Specify Varchar2(100)
AE_Attribution_Code Number(1)
AER_Filed Varchar2(1)
A sample record associated with the ADVERSE_EVENTS table will appear as follows:
"ADVERSE_EVENTS","<Protocol_ID>","<Patient_ID>",<Course_ID>,<AE_Type_Code>,<AE_Grade_Code>,"<AE_Other_Specify>",<AE_Attribution_Code>,"<AER_Filed>"
∗ Italicized items represent those elements that comprise the Primary Key.
CTEP Home Page: http://ctep.cancer.gov/ 8 May 3, 2002
1.7 TRIAL_COMMENTS TABLE
1.7.1 Field Name Change The following field name was changed to be consistent with CTEP terminology:
Original Field Name New Field Name
Gen_Tox_Comments Gen_AE_Comments
This is the only change to this table. All other information in this table remains the same.
1.8 PHASE1_END_POINT_DLTS TABLE
1.8.1 Field Name Change The following field name was changed to be consistent with CTEP terminology:
Original Field Name New Field Name
Tox_Type_Code AE_Type_Code
This is the only change to this table. All other information in this table remains the same.
∗ Italicized items represent those elements that comprise the Primary Key.
CTEP Home Page: http://ctep.cancer.gov/ 9 May 3, 2002
SECTION 2: New Information to be Collected – New Tables
2.1 PATIENT_RACES TABLE
The Health and Human Services, Office of Management and Budget has revised the race and ethnicity reporting requirements. All NCI sponsored trials must comply with these new guidelines. In summary, the new standards include:
• The ability to classify patients under more than one racial category (see Section 2.1.1),
• The separation of patient race and ethnicity into two data elements (see Section 2.1.2),
• The modification of patient race codes and descriptions (see Section 2.1.3), and
• The addition of patient ethnicity codes and descriptions (see Section 2.1.4).
Reporting Requirements: Reporting Patient Race information is mandatory for all CDUS-Complete and CDUS-Abbreviated studies.
Legacy Data2: Race and ethnicity information is required for all protocols.
For protocols approved prior to January 1, 2002, race and ethnicity information can continue to be collected using the old guidelines, however, this information must be mapped and submitted according to the table below. Mapping of Legacy Data to Revised Race and New Ethnicity Codes
LEGACY RACE AND ETHNICITY DATA
MAPPED TO REVISED CDUS 3.0 RACE AND ETHNICITY DATA
CODE DESCRIPTION RACE CODE
ETHNICITY CODE
RACE DESCRIPTION ETHNICITY DESCRIPTION
01 White, NOT of Hispanic origin 01 2 White Non-Hispanic
02 Hispanic 99 1 Unknown Hispanic or Latino
03 Black or African American, NOT of Hispanic origin
03 2 Black or African American
Non-Hispanic
04 Native Hawaiian or Other Pacific Islander
04 2 Native Hawaiian or Other Pacific Islander
Non-Hispanic
05 Asian 05 2 Asian Non-Hispanic
06 American Indian or Alaska Native
06 2 American Indian or Alaska Native
Non-Hispanic
98 Other 99 9 Unknown Unknown
99 Unknown 99 9 Unknown Unknown
For protocols approved on or after January 1, 2002, race and ethnicity information must be both collected and reported according to the new guidelines.
2.1.1 Multiracial Classification The PATIENT_RACES table was created to allow selection of multiple races when applicable to the patient. Patients may be classified as multiracial using one or more racial
2 Protocols activated on or after January 1, 2002 and patients accrued to studies prior to January 1, 2002 are defined as Legacy.
∗ Italicized items represent those elements that comprise the Primary Key.
CTEP Home Page: http://ctep.cancer.gov/ 10 May 3, 2002
categories. For example, a person of European and Chinese origins will be classified as (01) White and (05) Asian.
2.1.2 Separation of Race and Ethnicity Under the new guidelines, patient race and ethnicity are now collected as two separate data elements.
2.1.3 Revised Race Values The following racial categories are included in the updated standards as put forth by the Office of Management and Budget’s guidelines. Revised Patient Race Codes
CODE DESCRIPTION DEFINITION 01 White A person having origins in any of the original peoples of
Europe, the Middle East, or North Africa.
03 Black or African American A person having origins in any of the black racial groups of Africa. Terms such as "Haitian" or "Negro" can be used in addition to "Black or African American."
04 Native Hawaiian or Other Pacific Islander
A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
05 Asian A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.
06 American Indian or Alaska Native
A person having origins in any of the original peoples of North and South America (including Central America), and who maintains tribal affiliation or community attachment.
99 Unknown Unknown
2.1.4 Ethnicity Values With respect to ethnicity, the standards provide for the collection of data on whether a person is of "Hispanic or Latino" culture or origin. (The standards do not permit a multiple response that would indicate an ethnic heritage that is both Hispanic/Latino and non-Hispanic/non-Latino.) The new Patient Ethnicity Codes are listed below. New Patient Ethnicity Codes
CODE DESCRIPTION DEFINITION 1 Hispanic or Latino A person of Cuban, Mexican, Puerto Rican, South or
Central American, or other Spanish culture or origin, regardless of race.
2 Non-Hispanic A person NOT meeting the definition for Hispanic or Latino.
9 Unknown Unknown
Ethnicity information will now be collected in the PATIENTS table (see Section 1.3 for additional details).
∗ Italicized items represent those elements that comprise the Primary Key.
CTEP Home Page: http://ctep.cancer.gov/ 11 May 3, 2002
2.1.5 Technical Reporting Requirements Each record associated with the PATIENT_RACES table should consist of the following information:*
Protocol_ID Varchar2(35)
Patient_ID Varchar2(20)
Race_Code Varchar2(2)
A sample record associated with the PATIENT_RACES table will appear as follows:
"PATIENT_RACES","<Protocol_ID>","<Patient_ID>","<Race_Code>"
2.2 BASELINE_ABNORMALITIES TABLE
The BASELINE_ABNORMALITIES table was created to collect baseline abnormality information found during the initial history and physical examination for the patient. This information must be submitted when the Baseline_Abnormalities_Flag in the PATIENTS table (see Section 1.3) is set to 'Yes' and reported using the NCI Common Toxicity Criteria. Baseline abnormality information will provide CTEP with a baseline to use when analyzing treatment-related Adverse Events. If no baseline abnormalities were found during the patient’s initial examination, the Baseline_Abnormalities_Flag it set to 'No.'
Reporting Requirements: Reporting baseline abnormality information is mandatory for all CDUS-Complete studies, but is not required for CDUS-Abbreviated studies.
Legacy Data: Baseline abnormality information is required only for protocols activated on or after January 1, 2002.
2.2.1 Technical Reporting Requirements Each record associated with the BASELINE_ABNORMALITIES table should consist of the following information:*
Protocol_ID Varchar2(35)
Patient_ID Varchar2(20)
AE_Type_Code Number(10)
AE_Grade_Code Number(1)
AE_Other_Specify Varchar2(100)
A sample record associated with the BASELINE_ABNORMALITIES table will appear as follows:
"BASELINE_ABNORMALITIES","<Protocol_ID>","<Patient_ID>",<AE_Type_Code>,<AE_Grade_Code>, "<AE_Other_Specify>"
2.3 LATE_ADVERSE_EVENTS TABLE
In some cases, an Adverse Event is observed after a patient has completed treatment. Because these Adverse Events are not associated with a particular treatment course, they cannot be collected through the ADVERSE_EVENTS table (see Section1.6), which is linked to the TREATMENT_COURSES table. Under these circumstances, the Adverse Event is reported using the LATE_ADVERSE_EVENTS table. The Adverse Event is reported using the NCI Common Toxicity Criteria.
∗ Italicized items represent those elements that comprise the Primary Key.
CTEP Home Page: http://ctep.cancer.gov/ 12 May 3, 2002
Reporting Requirements: Reporting late Adverse Event information is mandatory for all CDUS-Complete studies, but is not required for CDUS-Abbreviated studies.
Legacy Data: Late Adverse Event information is required only for protocols activated on or after January 1, 2002.
2.3.1 Technical Reporting Requirements Each record associated with the LATE_ADVERSE_EVENTS table should consist of the following information:*
Protocol_ID Varchar2(35)
Patient_ID Varchar2(20)
AE_Type_Code Number(10)
AE_Grade_Code Number(1)
AE_Other_Specify Varchar2(100)
AE_Start_Date Date (YYYYMMDD)
A sample record associated with the LATE_ADVERSE_EVENTS table will appear as follows:
"LATE_ADVERSE_EVENTS","<Protocol_ID>","<Patient_ID>",<AE_Type_Code>,<AE_Grade_Code>,"<AE_Other_Specify>",<AE_Start_Date>
CTE
P H
ome
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: http
://ct
ep.c
ance
r.gov
/ 13
M
ay 3
, 200
2
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CTEP Home Page: http://ctep.cancer.gov/ 14 May 3, 2002
SECTION 4: Value Revisions
4.1 OFF_TREATMENT_REASON FROM THE PATIENTS TABLE
The value associated with code 03 was changed from 'Toxicity/Side Effects/Complications' to 'Adverse Event/Side Effects/Complications.'
The following values were added to the list of values for Off_TX_Reason: Added Value Code
Cytogenetic Resistance 11
Disease Progression before Active Treatment 12
The following value was removed from the list of values for Off_TX_Reason: Value Removed Code
Patient Declared Ineligible 09
4.2 THERAPY_CODE FROM THE PRIOR_THERAPIES TABLE
The value associated with MedDRA Code 900114 was changed from 'Gene Therapy' to 'Gene Transfer' (MedDRA v5.0 Code 90003004).
The following values were added to the list of values for Therapy_Code: Added Value MedDRA Code MedDRA v5.0 Code*
Anti-retroviral Therapy 900126 90003000
Antisense 900120 90003002
Chemotherapy non-cytotoxic 900128 90003018
Oncolytic Virotherapy 900124 90003008
Vaccine 900122 10036903
*It is recommended that MedDRA v5.0 codes be used.
4.3 UNIT_CODE FROM THE COURSE_AGENTS TABLE
The following values were added to the list of values for Unit_Code: Added Value Description
billion pfu Billion pfu
mcmol Micromole
million IU Million International Units
million pfu Million pfu
MVP Million Viral Particles
TCID Tissue Culture Infectious Dose
cells Cells
CTEP Home Page: http://ctep.cancer.gov/ 15 May 3, 2002
4.4 RACE_CODE FROM THE PATIENT_RACES TABLE AND ETHNICITY_FLAG FROM THE PATIENTS TABLE
The Patient Race Codes were modified by removing the Hispanic (02) Code and adding the Patient Ethnicity Codes (see Section 2.1 for additional details).
4.5 INTERNATIONAL MEDICAL TERMINOLOGY (IMT) AND MEDICAL DICTIONARY FOR REGULATORY ACTIVITIES (MEDDRA) TERMINOLOGY
All references to IMT Codes and terms have been replaced by references to Medical Dictionary of Regulatory Activities (MedDRA) Codes and terms. The International Conference on Harmonization has developed and extended the terminology (formerly referred to as IMT), and the "Implementable Version" of the new Medical Dictionary for Regulatory Activities (MedDRA) Terminology is intended for adoption internationally. Hence, what was formerly referred to as IMT is now referred to as MedDRA.
The codes and values used in the current version of CDUS will be upgraded to MedDRA version 5.0. Additional information, including a mapping document from the current version to the new version, will be provided in a separate correspondence from CTEP to assist with this transition. The following fields are affected:
Table Name Field Name
PATIENTS Disease_Code
PRIOR_THERAPY Therapy_Code
ADVERSE_EVENTS AE_Type_Code
PHASE1_END_POINT_DLTS AE_Type_Code
BASELINE_ABNORMALITIES AE_Type_Code
LATE_ADVERSE_EVENTS AE_Type_Code
CTEP Home Page: http://ctep.cancer.gov/ 16 May 3, 2002
SECTION 5:Changes to Field Attributes
5.1 DOSE_AMOUNT
The Dose_Amount column in the COURSE_AGENTS table was changed from Number(8) to Number(20,3) to allow for submission of up to 17 digits and three decimal places (a total of 20 digits can be entered).
5.2 COURSE_ID
The Course_ID field in the TREATMENT_COURSES, COURSE_AGENTS, and ADVERSE_EVENTS tables was changed from Varchar2(10) to Number(6); non-numeric values will no longer be accepted for this field. Course_ID information should be numbered sequentially; the CDUS Smart Loader will validate that the course information is provided in chronological order. For example, the start date for course 2 should be later than the start date for course 1.
5.3 UNIT_CODE
The Unit_Code field in the COURSE_AGENTS table was changed from Varchar2(5) to Varchar2(12).
CTE
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/ 17
M
ay 3
, 200
2
SEC
TIO
N 6
: New
and
/or R
evis
ed B
usin
ess
Rul
es
Plea
se u
se th
is v
ersi
on (M
ay 3
, 200
2) o
f the
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ines
s rul
es to
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e ad
just
men
ts in
you
r pro
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es. A
ll pr
evio
us v
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ons a
re n
ow o
bsol
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6.1
NEW
AN
D R
EVIS
ED B
USI
NES
S R
ULE
S (A
LREA
DY
IMPL
EMEN
TED
) Th
e ta
ble
belo
w d
escr
ibes
add
ed, r
emov
ed, o
r mod
ified
bus
ines
s rul
es th
at h
ave
been
impl
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ted
in p
revi
ous r
elea
ses o
f CD
US.
The
y ar
e lis
ted
here
fo
r doc
umen
tatio
n pu
rpos
es o
nly.
Tabl
e N
ame
Col
umn
Nam
e Pr
oble
m T
ype/
Erro
r Typ
eEr
ror T
ype
Erro
r Des
crip
tion
CO
LLEC
TIO
NS
SUBM
ISSI
ON
_DAT
E In
appr
opria
te M
anda
tory
R
EJEC
TIO
N
Mus
t be
<= S
yste
m D
ate
C
UTO
FF_D
ATE
Inap
prop
riate
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dato
ry
REJ
ECTI
ON
M
ust b
e <=
Sys
tem
Dat
e
C
UTO
FF_D
ATE
Inap
prop
riate
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dato
ry
REJ
ECTI
ON
M
ust b
e gr
eate
r tha
n or
equ
al to
the
prev
ious
sub
mis
sion
’s C
UTO
FF_D
ATE
LE
AD_O
RG
_ID
In
cons
iste
nt M
anda
tory
R
EJEC
TIO
N
Man
dato
ry d
ata
not c
onsi
sten
t with
pre
viou
s va
lue
PUBL
ICAT
ION
S YE
AR
Inap
prop
riate
Req
uest
ed
REJ
ECTI
ON
In
valid
Val
ue (Y
ear m
ust b
e >
'0')
PATI
ENTS
ZI
P_C
OD
E In
com
plet
e R
eque
sted
C
AUTI
ON
ZI
P_C
OD
E is
NU
LL (w
hen
CO
UN
TRY_
CO
DE
is N
ULL
and
ZIP
_CO
DE
is N
ULL
)
BI
RTH
_DAT
E In
appr
opria
te R
eque
sted
R
EJEC
TIO
N
Mus
t be
<= C
UTO
FF_D
ATE
D
ATE_
OF_
ENTR
Y In
appr
opria
te M
anda
tory
R
EJEC
TIO
N
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t be
<= C
UTO
FF_D
ATE
O
FF_T
X_R
EASO
N
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mpl
ete
Man
dato
ry
REJ
ECTI
ON
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st R
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nse
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rogr
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on is
man
dato
ry w
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OFF
_TX_
REA
SON
= '0
2'
O
FF_T
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EASO
N
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prop
riate
Man
dato
ry
REJ
ECTI
ON
O
FF_T
X_R
EASO
N m
ust b
e N
ULL
if T
X_O
N_S
TUD
Y =
'1'
O
FF_T
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EASO
N
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riate
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dato
ry
REJ
ECTI
ON
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ust b
e N
ULL
if T
X_O
N_S
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Y =
'1'
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TUS
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mpl
ete
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dato
ry
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ON
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NSE
S re
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ry w
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AL_S
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S =
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PRIO
R_T
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S TH
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Y_C
OD
E In
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plet
e M
anda
tory
R
EJEC
TIO
N
Prim
ary
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is N
ULL
TR
EATM
ENT_
CO
UR
SES
AE_E
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IEN
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plet
e M
anda
tory
R
EJEC
TIO
N
Adve
rse
Even
t rec
ords
man
dato
ry w
hen
AE_E
XPER
IEN
CED
= '1
'
TO
X_EX
PER
IEN
CED
In
cons
iste
nt M
anda
tory
W
ARN
ING
M
anda
tory
dat
a no
t con
sist
ent w
ith p
revi
ous
valu
e (In
activ
e)
ADVE
RSE
_EVE
NTS
AL
L C
OLU
MN
NAM
ES
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
Ad
vers
e Ev
ent r
ecor
ds c
an o
nly
be s
ubm
itted
whe
n AE
_EXP
ERIE
NC
ED =
'1'
BEST
_RES
PON
SES
CAT
EGO
RY
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
Be
st R
espo
nse
for P
rogr
essi
on is
man
dato
ry w
hen
OFF
_TX_
REA
SON
= '0
2'
C
ATEG
OR
Y In
appr
opria
te M
anda
tory
R
EJEC
TIO
N
TREA
TMEN
T_C
OU
RSE
S re
cord
man
dato
ry w
hen
BEST
_RES
PON
SES
reco
rd
exis
ts
O
BSER
VED
_DAT
E In
com
plet
e M
anda
tory
R
EJEC
TIO
N
Man
dato
ry C
olum
n is
NU
LL
O
BSER
VED
_DAT
E In
appr
opria
te M
anda
tory
R
EJEC
TIO
N
Mus
t be
>= fi
rst C
OU
RSE
_STA
RT_
DAT
E
O
BSER
VED
_DAT
E In
appr
opria
te M
anda
tory
R
EJEC
TIO
N
OBS
ERVE
D_D
ATE
<= C
UTO
FF_D
ATE
AL
L C
OLU
MN
NAM
ES
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
whe
n R
ESP_
EVAL
_STA
TUS
= '1
'
CTE
P H
ome
Page
: http
://ct
ep.c
ance
r.gov
/ 18
M
ay 3
, 200
2
Tabl
e N
ame
Col
umn
Nam
e Pr
oble
m T
ype/
Erro
r Typ
eEr
ror T
ype
Erro
r Des
crip
tion
AL
L C
OLU
MN
NAM
ES
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
BE
ST_R
ESPO
NSE
S re
cord
s ca
n on
ly b
e su
bmitt
ed w
hen
R
ESP_
EVAL
_STA
TUS
= '1
'
TRIA
L_C
OM
MEN
TS
SUBG
RO
UP_
CO
DE
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
whe
n TX
_ASG
NM
T_C
OD
E is
NU
LL
TX
_ASG
NM
T_C
OD
E In
com
plet
e M
anda
tory
R
EJEC
TIO
N
Man
dato
ry w
hen
SUBG
RO
UP_
CO
DE
is N
ULL
PHAS
E1_E
ND
_PO
INTS
TX
_ASG
NM
T_C
OD
E In
com
plet
e R
eque
sted
C
AUTI
ON
R
eque
sted
whe
n it
is a
Pha
se 1
tria
l with
a D
CTD
sup
plie
d in
vest
igat
iona
l age
nt
PHAS
E1_E
ND
_PO
INT_
DLT
S TO
X_TY
PE_C
OD
E In
com
plet
e M
anda
tory
R
EJEC
TIO
N
Man
dato
ry w
hen
it is
a P
hase
1 tr
ial w
ith a
DC
TD s
uppl
ied
inve
stig
atio
nal a
gent
TX
_ASG
NM
T_C
OD
E In
com
plet
e R
eque
sted
C
AUTI
ON
R
eque
sted
whe
n it
is a
Pha
se 1
tria
l with
a D
CTD
sup
plie
d in
vest
igat
iona
l age
nt
6.2
NEW
AN
D R
EVIS
ED B
USI
NES
S R
ULE
S (F
OR
IMPL
EMEN
TATI
ON
IN V
3.0)
Th
e ta
ble
belo
w p
rovi
des n
ew a
nd re
vise
d bu
sine
ss ru
les t
hat w
ill b
e im
plem
ente
d w
ith th
e re
st o
f the
CD
U v
ersi
on 3
.0 c
hang
es (i
.e.,
for t
he Q
uarte
r 2
2002
dat
a lo
ad d
ue Ju
ly 3
1, 2
002)
.
Tabl
e N
ame
Col
umn
Nam
e Pr
oble
m T
ype/
Erro
r Typ
eEr
ror T
ype
Erro
r Des
crip
tion
CO
LLEC
TIO
NS
CU
RR
ENT_
TRIA
L_ST
ATU
S_D
ATE
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
fiel
d is
NU
LL
C
UR
REN
T_TR
IAL_
STAT
US_
DAT
E In
appr
opria
te M
anda
tory
R
EJEC
TIO
N
Mus
t be
<= S
yste
m D
ate
CO
RR
ELAT
IVE_
STU
DIE
S PA
TIEN
TS_C
OLL
ECTE
D
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
fiel
d is
NU
LL
PA
TIEN
TS_C
OLL
ECTE
D
Inap
prop
riate
Man
dato
ry
CAU
TIO
N
Valu
e m
ust n
ot d
ecre
ase
over
tim
e
PA
TIEN
TS_C
OLL
ECTE
D
Inap
prop
riate
Man
dato
ry
REJ
ECTI
ON
M
ust b
e >=
PAT
IEN
TS_A
NAL
YZED
PA
TIEN
TS_C
OLL
ECTE
D
Inap
prop
riate
Man
dato
ry
REJ
ECTI
ON
M
ust b
e <=
SAM
PLES
_CO
LLEC
TED
PA
TIEN
TS_A
NAL
YZED
In
com
plet
e M
anda
tory
R
EJEC
TIO
N
Man
dato
ry fi
eld
is N
ULL
PA
TIEN
TS_A
NAL
YZED
In
appr
opria
te M
anda
tory
C
AUTI
ON
Va
lue
mus
t not
dec
reas
e ov
er ti
me
PA
TIEN
TS_A
NAL
YZED
In
appr
opria
te M
anda
tory
R
EJEC
TIO
N
Mus
t be
<= S
AMPL
ES_A
NAL
YZED
SA
MPL
ES_C
OLL
ECTE
D
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
for a
ll st
udie
s Ac
tivat
ed o
n or
afte
r 01/
01/2
002
SA
MPL
ES_C
OLL
ECTE
D
Inap
prop
riate
Man
dato
ry
CAU
TIO
N
Valu
e m
ust n
ot d
ecre
ase
over
tim
e
SA
MPL
ES_C
OLL
ECTE
D
Inap
prop
riate
Man
dato
ry
REJ
ECTI
ON
M
ust >
= SA
MPL
ES_A
NAL
YZED
SA
MPL
ES_A
NAL
YZED
In
com
plet
e M
anda
tory
R
EJEC
TIO
N
Man
dato
ry fo
r all
stud
ies
Activ
ated
on
or a
fter 0
1/01
/200
2
SA
MPL
ES_A
NAL
YZED
In
appr
opria
te M
anda
tory
C
AUTI
ON
Va
lue
mus
t not
dec
reas
e ov
er ti
me
AL
L C
OLU
MN
NAM
ES
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
C
orre
lativ
e St
udy
info
rmat
ion
Man
dato
ry if
Cor
rela
tive
ID a
bstra
cted
PATI
ENTS
BI
RTH
_DAT
E In
com
plet
e M
anda
tory
R
EJEC
TIO
N
Man
dato
ry fi
eld
is N
ULL
BI
RTH
_DAT
E In
appr
opria
te M
anda
tory
R
EJEC
TIO
N
Patie
nt a
ge m
ust b
e <=
100
at D
ate
of E
ntry
G
END
ER_C
OD
E In
com
plet
e M
anda
tory
R
EJEC
TIO
N
Man
dato
ry fi
eld
is N
ULL
ET
HN
ICIT
Y_FL
AG
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
fiel
d is
NU
LL
CTE
P H
ome
Page
: http
://ct
ep.c
ance
r.gov
/ 19
M
ay 3
, 200
2
Tabl
e N
ame
Col
umn
Nam
e Pr
oble
m T
ype/
Erro
r Typ
eEr
ror T
ype
Erro
r Des
crip
tion
R
ACE_
CO
DE
Inco
nsis
tent
Req
uest
ed
CAU
TIO
N
Dat
a no
t con
sist
ent w
ith p
revi
ous
valu
e
D
ATE_
OF_
ENTR
Y In
appr
opria
te M
anda
tory
R
EJEC
TIO
N
Mus
t be
>= d
ate
whe
n th
e C
UR
REN
T_TR
IAL_
STAT
US_
CO
DE
= 'A
C' (
Activ
e)
D
ATE_
OF_
ENTR
Y In
appr
opria
te M
anda
tory
R
EJEC
TIO
N
Mus
t be
<= d
ate
whe
n th
e C
UR
REN
T_TR
IAL_
STAT
US_
CO
DE
= 'C
L' (C
lose
d to
Ac
crua
l)
LA
ST_T
X_D
ATE
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
whe
n TX
_ON
_STU
DY
= '2
'; C
DU
S-C
ompl
ete;
and
stu
dy A
ctiv
ated
on
or
afte
r 01/
01/2
002
LA
ST_T
X_D
ATE
Inap
prop
riate
Man
dato
ry
REJ
ECTI
ON
M
ust b
e N
ULL
if T
X_O
N_S
TUD
Y =
'1';
CD
US-
Com
plet
e; a
nd s
tudy
Act
ivat
ed o
n or
af
ter 0
1/01
/200
2
LA
ST_T
X_D
ATE
Inap
prop
riate
Man
dato
ry
REJ
ECTI
ON
M
ust b
e >=
DAT
E_O
F_EN
TRY
LA
ST_T
X_D
ATE
Inco
nsis
tent
Man
dato
ry
CAU
TIO
N
Dat
a no
t con
sist
ent w
ith p
revi
ous
valu
e
O
FF_S
TUD
Y_R
EASO
N
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
if O
FF_S
TUD
Y_D
ATE
is N
OT
NU
LL
O
FF_S
TUD
Y_D
ATE
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
if O
FF_S
TUD
Y_R
EASO
N is
NO
T N
ULL
BA
SELI
NE_
ABN
OR
MAL
ITIE
S_FL
AG
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
whe
n th
e st
udy
has
been
ass
igne
d to
CD
US-
Com
plet
e an
d Ac
tivat
ed o
n or
afte
r 01/
01/2
002
BA
SELI
NE_
ABN
OR
MAL
ITIE
S_FL
AG
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
Ba
selin
e Ab
norm
aliti
es in
form
atio
n M
anda
tory
if
BASE
LIN
E_AB
NO
RM
ALIT
IES_
FLAG
= 'Y
es'
BA
SELI
NE_
ABN
OR
MAL
ITIE
S_FL
AG
Inco
nsis
tent
Man
dato
ry
CAU
TIO
N
Dat
a no
t con
sist
ent w
ith p
revi
ous
valu
e
BA
SELI
NE_
ABN
OR
MAL
ITIE
S_FL
AG
Inap
prop
riate
Man
dato
ry
REJ
ECTI
ON
M
ust b
e 'Y
es' i
f PAT
IEN
T_AB
NO
RM
ALIT
Y in
form
atio
n is
ent
ered
and
AB
NO
RM
ALIT
Y_TY
PE =
'Bas
elin
e'
PATI
ENT_
RAC
ES
RAC
E_C
OD
E In
com
plet
e M
anda
tory
R
EJEC
TIO
N
Prim
ary
Key
is N
ULL
R
ACE_
CO
DE
Inco
nsis
tent
Man
dato
ry
CAU
TIO
N
Dat
a no
t con
sist
ent w
ith p
revi
ous
valu
e
AL
L C
OLU
MN
NAM
ES
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
PA
TIEN
T_R
ACES
info
rmat
ion
Man
dato
ry if
pat
ient
reco
rd e
xist
s
TREA
TMEN
T_C
OU
RSE
S C
OU
RSE
_STA
RT_
DAT
E In
com
plet
e M
anda
tory
R
EJEC
TIO
N
Man
dato
ry d
ata
not s
ubm
itted
BASE
LIN
E_AB
NO
RM
ALIT
IES
TOX_
GR
ADE_
CO
DE
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
whe
n BA
SELI
NE_
ABN
OR
MAL
ITIE
S_FL
AG =
‘Yes
’ (M
anda
tory
whe
n TO
X_TY
PE_C
OD
E is
not
NU
LL)
AE
_OTH
ER_S
PEC
IFY
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
whe
n AE
_TYP
E_C
OD
E =
‘oth
er’
AL
L C
OLU
MN
NAM
ES
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
whe
n BA
SELI
NE_
ABN
OR
MAL
ITIE
S_FL
AG =
'Yes
'
AL
L C
OLU
MN
NAM
ES
Inap
prop
riate
Man
dato
ry
REJ
ECTI
ON
Ba
selin
e Ab
norm
ality
Rec
ords
may
onl
y be
sub
mitt
ed if
BA
SELI
NE_
ABN
OR
MAL
ITIE
S_FL
AG =
'Yes
'
ADVE
RSE
_EVE
NTS
AE
_OTH
ER_S
PEC
IFY
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
whe
n AE
_TYP
E_C
OD
E =
'oth
er';
CD
US-
Com
plet
e; a
nd A
ctiv
ated
on
or
afte
r 01/
01/2
002
LATE
_AD
VER
SE_E
VEN
TS
AE_O
THER
_SPE
CIF
Y In
com
plet
e M
anda
tory
R
EJEC
TIO
N
Man
dato
ry w
hen
AE_T
YPE_
CO
DE
= 'o
ther
'
TRIA
L_C
OM
MEN
TS
GEN
_RES
PON
SE_C
OM
MEN
TS
Inco
mpl
ete
Man
dato
ry
REJ
ECTI
ON
M
anda
tory
whe
n BE
ST_R
ESPO
NSE
S.C
ATEG
OR
Y =
'98'
(Oth
er) ;
CD
US-
Com
plet
e ; a
nd A
ctiv
ated
on
or a
fter 0
1/01
/200
2
CTE
P H
ome
Page
: http
://ct
ep.c
ance
r.gov
/ 20
M
ay 3
, 200
2
6.3
BU
SIN
ESS
RU
LES
WH
ERE
A W
AR
NIN
G W
ILL
CH
AN
GE
TO A
CA
UTI
ON
(FO
R IM
PLEM
ENTA
TIO
N IN
APR
IL 2
002)
A
fter r
ecei
ving
feed
back
from
man
y si
tes,
it ha
s bee
n de
cide
d th
at e
rror
s rai
sed
due
to in
cons
iste
nt m
anda
tory
dat
a w
ill b
e do
wng
rade
d fr
om W
AR
NIN
G
erro
rs to
CA
UTI
ON
err
ors.
Site
s will
no
long
er n
eed
to p
rovi
de C
TEP
with
ver
ifica
tion
that
the
late
st d
ata
is c
orre
ct.
How
ever
, as w
ith a
ll C
AU
TIO
N
erro
rs, C
TEP
expe
cts s
ites t
o re
view
thes
e er
rors
to e
nsur
e th
at th
e da
ta b
eing
subm
itted
is c
orre
ct a
nd a
ccur
ate.
Thi
s cha
nge
will
be
impl
emen
ted
with
th
e Q
uarte
r 1 2
002
data
load
(due
Apr
il 30
, 200
2).
Tabl
e N
ame
Col
umn
Nam
e Pr
oble
m T
ype/
Erro
r Typ
eEr
ror T
ype
Erro
r Des
crip
tion
PATI
ENTS
D
ATE_
OF_
ENTR
Y In
cons
iste
nt M
anda
tory
C
AUTI
ON
M
anda
tory
dat
a no
t con
sist
ent w
ith p
revi
ous
valu
e
D
ISEA
SE_C
OD
E In
cons
iste
nt M
anda
tory
C
AUTI
ON
M
anda
tory
dat
a no
t con
sist
ent w
ith p
revi
ous
valu
e
O
FF_T
X_R
EASO
N
Inco
nsis
tent
Man
dato
ry
CAU
TIO
N
Man
dato
ry d
ata
not c
onsi
sten
t with
pre
viou
s va
lue
R
EG_G
RO
UP_
ID
Inco
nsis
tent
Man
dato
ry
CAU
TIO
N
Man
dato
ry d
ata
not c
onsi
sten
t with
pre
viou
s va
lue
R
EG_I
NST
_ID
In
cons
iste
nt M
anda
tory
C
AUTI
ON
M
anda
tory
dat
a no
t con
sist
ent w
ith p
revi
ous
valu
e
SU
BGR
OU
P_C
OD
E In
cons
iste
nt M
anda
tory
C
AUTI
ON
M
anda
tory
dat
a no
t con
sist
ent w
ith p
revi
ous
valu
e
TREA
TMEN
T_C
OU
RSE
S TX
_ASG
NM
T_C
OD
E In
cons
iste
nt M
anda
tory
C
AUTI
ON
M
anda
tory
dat
a no
t con
sist
ent w
ith p
revi
ous
valu
e
ADVE
RSE
_EVE
NTS
TO
X_AT
TRIB
UTI
ON
_CO
DE
Inco
nsis
tent
Man
dato
ry
CAU
TIO
N
Man
dato
ry d
ata
not c
onsi
sten
t with
pre
viou
s va
lue
BEST
_RES
PON
SES
OBS
ERVE
D_D
ATE
Inco
nsis
tent
Man
dato
ry
CAU
TIO
N
Man
dato
ry d
ata
not c
onsi
sten
t with
pre
viou
s va
lue
CTEP Home Page: http://ctep.cancer.gov/ 21 May 3, 2002
SECTION 7: Clarifications/New Instructions for Data Submissions
7.1 RESPONSE INFORMATION
a. There have been several queries related to reporting response information for protocols that do not use traditional response criteria. If the protocol does not use the traditional response criteria provided in the list of values (e.g., where the response is based on serum level changes of a particular factor), then the value 'Other' should be submitted. If 'Other' is submitted, it is mandatory that information about the patient’s response be submitted using the Gen_Response_Comments field as described in detail in the TRIAL_COMMENTS table section of the CDUS Instructions and Guidelines.
b. Progression should be reported even if it is experienced after a response (e.g., Less than Partial Response, Partial Response, Complete Response).
c. The Observed_Date from the BEST_RESPONSES table is mandatory for all CDUS-Complete responses submitted, including Stable Disease. The Observed_Date for Stable Disease is reported as the date that the test or procedure was performed that indicated that the patient had stable disease.
7.2 TREATMENT_COURSES TABLE, AE_EXPERIENCED FLAG
The codes (1) Yes, (2) No, and (3) Too Early to Evaluate are the valid values available to indicate that a patient experienced an Adverse Event on the current course of therapy. This information is reported using the AE_Experienced field in the TREATMENT_COURSES table.
To accommodate all reporting situations, the definition of 'No' has been refined to indicate that the patient did not experience any Adverse Events that are required to be reported via CDU. For example, if during a course of treatment a patient only experienced a Grade 1 Adverse Event with an attribution of 'Unlikely,' then the AE_Experienced flag may be reported as 'No.' The site is not required to report the event.
However, although not required by CTEP, the site does have the option to choose to report these events. If a site chooses to report these cases to CTEP, then the AE_Experienced flag should be reported as 'Yes.'
7.3 SUBGROUP, TREATMENT ASSIGNMENT CODES AND CORRELATIVE STUDY IDS AND DESCRIPTIONS
Subgroup Codes, Treatment Assignment Codes, and Correlative Study IDs and their descriptions were previously created and submitted by the investigator to CTEP via the Protocol Submission Worksheet (PSW). This information is now abstracted from the protocol by CTEP staff. After a protocol is approved, the codes and descriptions assigned by CTEP are submitted to the investigator and CDU contact for review and acceptance. Additionally, this information is sent quarterly with the List of Expected Protocols for each site.
7.4 SMART LOADER REMINDER, WARNING, AND SUSPENSION PROCESS
The CDU data resubmission timeline was modified for files with rejection errors. If no verification and/or resubmission is received by CTEP, the following correspondences will occur:
• 5 working days after a rejection notice is sent – reminder notice
• 10 working days after the rejection notice is sent – warning notice
CTEP Home Page: http://ctep.cancer.gov/ 22 May 3, 2002
• 15 working days after rejection notice is sent – suspension notice
The timeline for sending notices listed above will begin on the submission due date for the data.
If no file is received for an expected protocol, then notices are sent according to the following timeline:
• 1 working day after the due date – late notice
• 10 working days after the due date – warning notice
• 15 working days after the due date – suspension notice
7.5 REFERENCE REMOVED
A footnote on page 11 of version 2.1 of the CDUS I&G stated "the final study report requirements for Phase 1-3 studies are posted on the CTEP Home Page at http://ctep.info.nih.gov/PAMO/ProtocolInfOffice.htm." This reference is invalid and was removed. Please contact the CTEP Protocol Information Office at (301) 496-1367 for questions about final study report requirements.
7.6 REGISTERING GROUP ID
Collection of Reg_Group_ID from the PATIENTS table was expanded to include all trials with Group participation, not just Intergroup trials. For example, Registering Group information is collected for trials with John’s Hopkins University as the lead, but with ECOG as a participating Group.
This information is mandatory for both CDUS-Complete and CDUS-Abbreviated studies.
7.7 REGISTERING INSTITUTION ID
Because the lead Group on an Intergroup trial may have difficulty determining the correct Institution Code for patients registered outside the Lead Group, CTEP developed a Web site to assist in identifying the correct Reg_Inst_ID (see Section 1.3 for information on the PATIENTS table). The institution names and codes for each Group can be found from the CTEP Home Page.
7.8 PHASE I END POINTS
The instruction for the PHASE1_END_POINTS table was modified to include collecting either the recommended Phase 2 dose or the minimum effective dose depending on the protocol objectives.
CTE
P H
ome
Page
: http
://ct
ep.c
ance
r.gov
/ A-
1 M
ay 3
, 200
2
App
endi
x A
: Sum
mar
y Li
st o
f Mod
ifica
tions
R
epor
ting
Req
uire
men
ts
D
escr
iptio
n of
Cha
nge
CD
US-
Com
plet
e C
DU
S-Ab
brev
iate
d Le
gacy
Dat
a R
equi
rem
ents
C
omm
ents
New
Info
rmat
ion
to b
e C
olle
cted
: Mod
ifica
tion
to E
xist
ing
Tabl
es (
CD
US
Not
ice
of M
odifi
catio
ns, S
ectio
n 1)
CO
LLEC
TIO
NS
Tabl
e (C
DU
S N
otic
e of
Mod
ifica
tions
, Sec
tion
1.1)
Th
e C
OLL
ECTI
ON
S ta
ble
was
mod
ified
by
addi
ng th
e fo
llow
ing
field
s:
1.
Th
e C
urre
nt_T
rial_
Stat
us_D
ate
field
was
add
ed to
col
lect
the
date
the
curr
ent p
roto
col s
tatu
s too
k ef
fect
(e.g
., if
the
curr
ent s
tatu
s is a
ctiv
e,
and
the
prot
ocol
bec
ame
activ
e on
Janu
ary
15, 2
000,
then
200
0011
5 [u
sing
the
stan
dard
dat
e fo
rmat
of Y
YY
YM
MD
D] i
s sub
mitt
ed a
s the
C
urre
nt_T
rial_
Stat
us_D
ate)
.
Man
dato
ry
Man
dato
ry
Req
uire
d fo
r all
prot
ocol
s.
To a
ssis
t in
dete
rmin
ing
the
Cur
rent
_Tria
l_St
atus
_Dat
e, C
TEP
will
in
clud
e th
e cu
rren
t pro
toco
l sta
tus a
nd d
ate
with
eac
h si
te’s
qua
rterly
Lis
t of E
xpec
ted
Prot
ocol
s.
CO
RR
ELA
TIVE
_STU
DIE
S Ta
ble
(CD
US
Not
ice
of M
odifi
catio
ns, S
ectio
n 1.
2)
C
orre
lativ
e st
udy
info
rmat
ion
is n
ow m
anda
tory
for a
ll pr
otoc
ols w
ith
embe
dded
cor
rela
tive
stud
ies r
egar
dles
s of t
he m
onito
ring
met
hod.
The
CO
RR
ELA
TIV
E_ST
UD
IES
tabl
e w
as m
odifi
ed by
add
ing
the
follo
win
g fie
lds:
M
anda
tory
ON
LY fo
r pro
toco
ls w
ith
embe
dded
cor
rela
tive
stud
ies.
1.
Th
e Sa
mpl
es_C
olle
cted
fiel
d w
as a
dded
to c
olle
ct th
e nu
mbe
r of
sam
ples
col
lect
ed a
cros
s pat
ient
s on
the
corr
elat
ive
stud
y.
Man
dato
ry
Man
dato
ry
Req
uire
d on
ly fo
r pro
toco
ls
activ
ated
on
or a
fter J
anua
ry 1
, 20
02.
2.
Th
e Sa
mpl
es_A
naly
zed
field
was
add
ed to
col
lect
the
num
ber o
f sa
mpl
es a
naly
zed
acro
ss p
atie
nts o
n th
e co
rrel
ativ
e st
udy.
M
anda
tory
M
anda
tory
R
equi
red
only
for p
roto
cols
ac
tivat
ed o
n or
afte
r Jan
uary
1,
2002
.
PATI
ENTS
Tab
le (
CD
US
Not
ice
of M
odifi
catio
ns, S
ectio
n 1.
3)
Th
e PA
TIEN
TS ta
ble
was
mod
ified
by
addi
ng o
r rem
ovin
g th
e fo
llow
ing
field
s:
1.
Th
e Et
hnic
ity_F
lag
was
add
ed to
iden
tify
whe
ther
a p
erso
n is
of
His
pani
c or
Lat
ino
cultu
re o
r orig
in.
Man
dato
ry
Man
dato
ry
Req
uire
d fo
r all
prot
ocol
s.
Rac
e an
d et
hnic
ity in
form
atio
n fo
r pro
toco
ls
appr
oved
on
or a
fter J
anua
ry 1
, 200
2, m
ust
be b
oth
colle
cted
and
repo
rted
acco
rdin
g to
th
e ne
w g
uide
lines
(see
Sec
tion
2.1)
. Dat
a fo
r pr
otoc
ols a
ppro
ved
prio
r to
Janu
ary
1, 2
002,
m
ust b
e m
appe
d ac
cord
ing
to S
ectio
n 2.
1.
See
Sect
ion
2.1.
4 fo
r a c
ompl
ete
list o
f Et
hnic
ity v
alue
s.
CTE
P H
ome
Page
: http
://ct
ep.c
ance
r.gov
/ A-
2 M
ay 3
, 200
2
Rep
ortin
g R
equi
rem
ents
D
escr
iptio
n of
Cha
nge
CD
US-
Com
plet
e C
DU
S-Ab
brev
iate
d Le
gacy
Dat
a R
equi
rem
ents
C
omm
ents
2.
Th
e La
st_T
X_D
ate
field
was
add
ed to
indi
cate
the
date
of t
he p
atie
nt’s
la
st tr
eatm
ent.
Man
dato
ry
Not
Req
uire
d R
equi
red
only
for p
roto
cols
ac
tivat
ed o
n or
afte
r Jan
uary
1,
2002
.
The
Last
_TX
_Dat
e fie
ld m
ust b
e su
bmitt
ed
whe
n th
e pa
tient
is re
porte
d as
off
pro
toco
l tre
atm
ent (
usin
g th
e st
anda
rd d
ate
form
at o
f Y
YY
YM
MD
D).
3.
Th
e O
ff_S
tudy
_Rea
son
field
was
add
ed to
col
lect
the
reas
on th
at th
e pa
tient
wen
t off
stud
y.
Man
dato
ry
Not
Req
uire
d R
equi
red
only
for p
roto
cols
ac
tivat
ed o
n or
afte
r Jan
uary
1,
2002
.
See
Sect
ion
1.3.
3 fo
r a c
ompl
ete
set o
f O
ff_S
tudy
_Rea
son
valid
val
ues.
4.
Th
e O
ff_S
tudy
_Dat
e fie
ld w
as a
dded
to c
olle
ct th
e da
te a
pat
ient
wen
t of
f stu
dy.
Man
dato
ry
Not
Req
uire
d R
equi
red
only
for p
roto
cols
ac
tivat
ed o
n or
afte
r Jan
uary
1,
2002
.
5.
Th
e B
asel
ine_
Abn
orm
aliti
es_F
lag
was
add
ed to
indi
cate
whe
ther
ba
selin
e ab
norm
aliti
es w
ere
foun
d du
ring
the
patie
nt’s
initi
al h
isto
ry
and
phys
ical
exa
min
atio
n.
Man
dato
ry
Not
Req
uire
d R
equi
red
only
for p
roto
cols
ac
tivat
ed o
n or
afte
r Jan
uary
1,
2002
.
6.
Th
e G
ende
r_C
ode
field
is n
ow m
anda
tory
for a
ll pr
otoc
ols.
Man
dato
ry
Man
dato
ry
Req
uire
d fo
r all
prot
ocol
s. N
ew re
porti
ng re
quire
men
t onl
y.
7.
Th
e B
irth_
Dat
e fie
ld is
now
man
dato
ry fo
r all
prot
ocol
s. M
anda
tory
M
anda
tory
R
equi
red
for a
ll pr
otoc
ols.
New
repo
rting
requ
irem
ent o
nly.
8.
Th
e R
ace_
Cod
e fie
ld w
as m
oved
to th
e PA
TIEN
T_R
AC
ES ta
ble.
Rac
e in
form
atio
n is
now
subm
itted
usi
ng th
e PA
TIEN
T_R
AC
ES ta
ble.
N
ot A
pplic
able
N
ot A
pplic
able
N
ot A
pplic
able
. Se
e Se
ctio
n 2.
1 fo
r inf
orm
atio
n on
the
PATI
ENT_
RA
CES
tabl
e.
9.
Th
e El
igib
ility
_Sta
tus f
ield
was
rena
med
to In
elig
ibili
ty_S
tatu
s. N
ot A
pplic
able
N
ot A
pplic
able
N
ot A
pplic
able
.
TREA
TMEN
T_C
OU
RSE
S Ta
ble
(CD
US
Not
ice
of M
odifi
catio
ns, S
ectio
n 1.
4)
1.
Th
e To
x_Ex
perie
nced
fiel
d na
me
was
cha
nged
to A
E_Ex
perie
nced
to
be c
onsi
sten
t with
CTE
P te
rmin
olog
y.
Not
App
licab
le
Not
App
licab
le
2.
Th
e at
tribu
te fo
r the
Cou
rse_
ID fi
eld
was
cha
nged
from
Var
char
2(10
) to
Num
ber(
6).
Not
App
licab
le
Not
App
licab
le
Se
e Se
ctio
n 5.
2 fo
r add
ition
al in
form
atio
n.
CO
UR
SE_A
GEN
TS T
able
(CD
US
Not
ice
of M
odifi
catio
ns, S
ectio
n 1.
5)
Th
e at
tribu
te fo
r the
Cou
rse_
ID fi
eld
was
cha
nged
from
Var
char
2(10
) to
Num
ber(
6).
Not
App
licab
le
Not
App
licab
le
Se
e Se
ctio
n 5.
2 fo
r add
ition
al in
form
atio
n.
ADVE
RSE
_EVE
NTS
Tab
le (F
orm
erly
the
TOXI
C_E
VEN
TS T
able
) (C
DU
S N
otic
e of
Mod
ifica
tions
, Sec
tion
1.6)
Th
e TO
XIC
_EV
ENTS
tabl
e na
me
was
cha
nged
and
the
tabl
e m
odifi
ed b
y ad
ding
the
follo
win
g fie
ld a
nd re
porti
ng re
quire
men
t:
1.
The
TO
XIC
_EV
ENTS
tabl
e na
me
was
cha
nged
to th
e A
DV
ERSE
_EV
ENTS
tabl
e.
Not
App
licab
le
Not
App
licab
le
CTE
P H
ome
Page
: http
://ct
ep.c
ance
r.gov
/ A-
3 M
ay 3
, 200
2
Rep
ortin
g R
equi
rem
ents
D
escr
iptio
n of
Cha
nge
CD
US-
Com
plet
e C
DU
S-Ab
brev
iate
d Le
gacy
Dat
a R
equi
rem
ents
C
omm
ents
2.
The
Tox
_Typ
e_C
ode
field
nam
e w
as c
hang
ed to
AE_
Type
_Cod
e, th
e To
x_G
rade
_Cod
e fie
ld n
ame
was
cha
nged
to A
E_G
rade
_Cod
e, a
nd th
e To
x_A
ttrib
utio
n_C
ode
field
nam
e w
as c
hang
ed to
A
E_A
ttrib
utio
n_C
ode
to b
e co
nsis
tent
with
CTE
P te
rmin
olog
y.
Not
App
licab
le
Not
App
licab
le
3.
The
attr
ibut
e fo
r the
Cou
rse_
ID fi
eld
was
cha
nged
from
Var
char
2(10
) to
Num
ber(
6).
Not
App
licab
le
Not
App
licab
le
Se
e Se
ctio
n 5.
2 fo
r add
ition
al in
form
atio
n.
4.
The
AE_
Oth
er_S
peci
fy fi
eld
was
add
ed to
col
lect
Adv
erse
Eve
nts
whe
n th
e op
tion
'Oth
er, S
peci
fy' i
s sel
ecte
d w
ithin
a C
TC c
ateg
ory.
M
anda
tory
N
ot R
equi
red
Req
uire
d on
ly fo
r pro
toco
ls
activ
ated
on
or a
fter J
anua
ry 1
, 20
02.
5.
Gra
de 3
Adv
erse
Eve
nts w
ith a
n at
tribu
tion
of U
nrel
ated
or U
nlik
ely
was
add
ed a
s a re
porti
ng re
quire
men
t.
Man
dato
ry
Not
Req
uire
d R
equi
red
only
for p
roto
cols
ac
tivat
ed o
n or
afte
r Jan
uary
1,
2002
.
New
repo
rting
requ
irem
ent o
nly.
See
Sect
ion
1.6.
4 fo
r add
ition
al in
form
atio
n on
Adv
erse
Eve
nt R
epor
ting
Req
uire
men
ts.
TRIA
L_C
OM
MEN
TS T
able
(CD
US
Not
ice
of M
odifi
catio
ns, S
ectio
n 1.
7)
Th
e G
en_T
ox_C
omm
ents
fiel
d na
me
was
cha
nged
to G
en_A
E_C
omm
ents
to
be
cons
iste
nt w
ith C
TEP
term
inol
ogy.
N
ot A
pplic
able
N
ot A
pplic
able
PHAS
E1_E
ND
_PO
INTS
Tab
le (C
DU
S N
otic
e of
Mod
ifica
tions
, Sec
tion
1.8)
Th
e To
x_Ty
pe_C
ode
field
nam
e w
as c
hang
ed to
AE_
Type
_Cod
e to
be
cons
iste
nt w
ith C
TEP
term
inol
ogy.
N
ot A
pplic
able
N
ot A
pplic
able
New
Info
rmat
ion
to b
e C
olle
cted
: New
Tab
les
(CD
US
Not
ice
of M
odifi
catio
ns, S
ectio
n 2)
PATI
ENT_
RA
CES
Tab
le (
CD
US
Not
ice
of M
odifi
catio
ns, S
ectio
n 2.
1)
Th
e PA
TIEN
T_R
AC
ES ta
ble
was
cre
ated
to c
olle
ct m
ultir
acia
l pat
ient
cl
assi
ficat
ion.
•
Patie
nts a
re c
lass
ified
by
all r
acia
l cat
egor
ies t
hat a
pply
(e.g
., a
patie
nt o
f Eur
opea
n an
d C
hine
se o
rigin
is c
lass
ified
as [
01] W
hite
an
d [0
5] A
sian
). •
Rev
ised
Rac
e C
odes
and
des
crip
tions
and
new
Eth
nici
ty C
odes
and
de
scrip
tions
are
ava
ilabl
e.
• R
ace
and
ethn
icity
info
rmat
ion
are
now
add
ress
ed a
s sep
arat
e da
ta
elem
ents
. Eth
nici
ty in
form
atio
n is
col
lect
ed in
the
PATI
ENTS
tabl
e.
Man
dato
ry
Man
dato
ry
Req
uire
d fo
r all
prot
ocol
s.
For p
roto
cols
app
rove
d on
or
afte
r Jan
uary
1, 2
002,
race
and
et
hnic
ity in
form
atio
n m
ust b
e bo
th c
olle
cted
and
repo
rted
acco
rdin
g to
the
new
gu
idel
ines
.
Rac
e an
d et
hnic
ity in
form
atio
n fo
r pro
toco
ls
appr
oved
prio
r to
Janu
ary
1, 2
002
can
cont
inue
to b
e co
llect
ed u
sing
the
old
guid
elin
es, h
owev
er th
is in
form
atio
n m
ust b
e m
appe
d ac
cord
ing
to S
ectio
n 2.
1.
See
Sect
ion
1.3.
6 fo
r rac
e co
de in
form
atio
n,
Sect
ion
2.1.
4 fo
r eth
nici
ty v
alue
s, an
d Se
ctio
n 1.
3 fo
r inf
orm
atio
n on
the
PATI
ENTS
tabl
e.
CTE
P H
ome
Page
: http
://ct
ep.c
ance
r.gov
/ A-
4 M
ay 3
, 200
2
Rep
ortin
g R
equi
rem
ents
D
escr
iptio
n of
Cha
nge
CD
US-
Com
plet
e C
DU
S-Ab
brev
iate
d Le
gacy
Dat
a R
equi
rem
ents
C
omm
ents
BAS
ELIN
E_A
BN
OR
MAL
ITIE
S Ta
ble
(CD
US
Not
ice
of M
odifi
catio
ns, S
ectio
n 2.
2)
Th
e B
ASE
LIN
E_A
BN
OR
MA
LITI
ES ta
ble
was
cre
ated
to c
olle
ct b
asel
ine
abno
rmal
ities
foun
d du
ring
a pa
tient
’s in
itial
his
tory
and
phy
sica
l ex
amin
atio
n.
Man
dato
ry
Not
Req
uire
d R
equi
red
only
for p
roto
cols
ac
tivat
ed o
n or
afte
r Jan
uary
1,
2002
.
Bas
elin
e ab
norm
ality
info
rmat
ion
is
subm
itted
usi
ng th
e N
CI C
TC.
Bas
elin
e ab
norm
ality
info
rmat
ion
is
man
dato
ry w
hen
the
Bas
elin
e_A
bnor
mal
ities
_Fla
g in
the
PATI
ENTS
tabl
e is
'Yes
.'
LATE
_AD
VER
SE_E
VEN
TS T
able
(C
DU
S N
otic
e of
Mod
ifica
tions
, Sec
tion
2.3)
Th
e LA
TE_A
DV
ERSE
_EV
ENTS
tabl
e w
as c
reat
ed to
col
lect
Adv
erse
Ev
ents
not
ass
ocia
ted
with
spec
ific
treat
men
t cou
rses
(i.e
., an
adv
erse
ev
ent o
bser
ved
in a
pat
ient
that
no
long
er re
ceiv
es tr
eatm
ent).
Man
dato
ry
Not
Req
uire
d R
equi
red
only
for p
roto
cols
ac
tivat
ed o
n or
afte
r Jan
uary
1,
2002
.
Valu
e R
evis
ions
(C
DU
S N
otic
e of
Mod
ifica
tions
, Sec
tion
4)
1.
O
ff_T
X_R
easo
n fr
om th
e PA
TIEN
TS T
able
– T
he v
alue
'Tox
icity
/Sid
e Ef
fect
/Com
plic
atio
ns' w
as re
vise
d to
'Adv
erse
Eve
nt/S
ide
Effe
ct/C
ompl
icat
ions
' to
be c
onsi
sten
t with
CTE
P te
rmin
olog
y.
'Cyt
ogen
etic
resi
stan
ce' a
nd 'D
isea
se p
rogr
essi
on b
efor
e ac
tive
treat
men
t' w
ere
adde
d to
the
Off
_TX
_Rea
son
list o
f val
ues.
'Pat
ient
de
clar
ed in
elig
ible
' was
rem
oved
from
the
Off
_TX
_Rea
son
list o
f va
lues
.
Not
App
licab
le
Not
App
licab
le
Not
App
licab
le.
2.
Th
erap
y_C
ode
from
the
PRIO
R_T
HER
API
ES T
able
– T
he v
alue
as
soci
ated
with
Med
DR
A C
ode
9001
14 w
as c
hang
ed fr
om 'G
ene
Ther
apy'
to 'G
ene
Tran
sfer
.' In
add
ition
, sev
eral
new
val
ues h
ave
been
ad
ded
to th
e Th
erap
y_C
ode
list o
f val
ues.
Not
App
licab
le
Not
App
licab
le
Not
App
licab
le.
See
Sect
ion
4.2
for t
he a
dded
Th
erap
y_C
odes
.
3.
U
nit_
Cod
e fr
om th
e C
OU
RSE
_AG
ENTS
Tab
le –
seve
ral n
ew v
alue
s ha
ve b
een
adde
d to
the
Uni
t Cod
e lis
t of v
alue
s. N
ot A
pplic
able
N
ot A
pplic
able
N
ot A
pplic
able
. Se
e Se
ctio
n 4.
3 fo
r the
add
ed U
nit_
Cod
es.
4.
R
ace_
Cod
e fr
om th
e PA
TIEN
T_R
AC
ES T
able
– T
he p
atie
nt
Rac
e_C
ode
listin
g w
as re
vise
d.
Not
App
licab
le
Not
App
licab
le
Not
App
licab
le.
See
Sect
ion
1.3.
6 fo
r Rac
e_C
odes
.
5.
Et
hnic
ity_F
lag
from
the
PATI
ENTS
Tab
le –
New
cod
es w
ere
adde
d fo
r use
with
the
Ethn
icity
_Fla
g.
Not
App
licab
le
Not
App
licab
le
Not
App
licab
le.
See
Sect
ion
2.1.
4 fo
r Eth
nici
ty_F
lag
valu
es.
6.
M
edic
al D
ictio
nary
for R
egul
ator
y A
ctiv
ities
(Med
DR
A) T
erm
inol
ogy:
A
ll re
fere
nces
to In
tern
atio
nal M
edic
al T
erm
inol
ogy
(IM
T) c
odes
and
te
rms w
ere
repl
aced
with
cod
es a
nd te
rms f
rom
the
Med
ical
Dic
tiona
ry
of R
egul
ator
y A
ctiv
ities
(Med
DR
A).
Not
App
licab
le
Not
App
licab
le
Not
App
licab
le.
See
Sect
ion
4.5
for a
com
plet
e lis
t of a
ffec
ted
field
s.
CTE
P H
ome
Page
: http
://ct
ep.c
ance
r.gov
/ A-
5 M
ay 3
, 200
2
Rep
ortin
g R
equi
rem
ents
D
escr
iptio
n of
Cha
nge
CD
US-
Com
plet
e C
DU
S-Ab
brev
iate
d Le
gacy
Dat
a R
equi
rem
ents
C
omm
ents
Cha
nges
to F
ield
Attr
ibut
es (
CD
US
Not
ice
of M
odifi
catio
ns, S
ectio
n 5)
1.
Th
e D
ose_
Am
ount
fiel
d in
the
CO
UR
SE_A
GEN
TS ta
ble
was
cha
nged
fr
om N
umbe
r(20
) to
Num
ber(
20,3
) to
subm
it up
to th
ree
deci
mal
pl
aces
.
Not
App
licab
le
Not
App
licab
le
Not
App
licab
le.
2.
Th
e C
ours
e_ID
fiel
d in
the
TREA
TMEN
T_C
OU
RSE
S,
CO
UR
SE_A
GEN
TS, a
nd A
DV
ERSE
_EV
ENTS
tabl
es w
as c
hang
ed
from
Var
char
2(10
) to
Num
ber(
6).
Non
-num
eric
val
ues w
ill n
o lo
nger
be
acc
epte
d fo
r thi
s fie
ld.
Not
App
licab
le
Not
App
licab
le
Not
App
licab
le.
3.
Th
e U
nit_
Cod
e fie
ld in
the
CO
UR
SE_A
GEN
TS ta
ble
was
cha
nged
fr
om V
arch
ar2(
5) to
Var
char
2(12
). N
ot A
pplic
able
N
ot A
pplic
able
N
ot A
pplic
able
.
New
and
/or R
evis
ed B
usin
ess
Rul
es (
CD
US
Not
ice
of M
odifi
catio
ns, S
ectio
n 6)
Plea
se re
fer t
o Se
ctio
n 6
of th
e C
DU
S N
otic
e of
Mod
ifica
tion
date
d M
ay
3, 2
002
for a
com
plet
e lis
t of a
ll ne
w a
nd/o
r rev
ised
bus
ines
s rul
es. A
ll pr
evio
us v
ersi
ons a
re o
bsol
ete.
Cla
rific
atio
ns/N
ew In
stru
ctio
ns fo
r Dat
a Su
bmis
sion
s (C
DU
S N
otic
e of
Mod
ifica
tions
, Sec
tion
7)
Res
pons
e In
form
atio
n (C
DU
S N
otic
e of
Mod
ifica
tions
, Sec
tion
7.1)
1.
Pa
tient
resp
onse
info
rmat
ion
is n
ow m
anda
tory
whe
n th
e va
lue
'Oth
er'
is se
lect
ed fo
r the
pat
ient
’s th
erap
y re
spon
se ('
Oth
er' i
s gen
eral
ly
sele
cted
for p
roto
cols
that
do
not u
se tr
aditi
onal
resp
onse
crit
eria
).
Man
dato
ry
Not
Req
uire
d R
equi
red
only
for p
roto
cols
ac
tivat
ed o
n or
afte
r Jan
uary
1,
2002
.
Entry
of r
espo
nse
info
rmat
ion
is d
one
usin
g th
e TR
IAL_
CO
MM
ENTS
tabl
e,
Gen
_Res
pons
e_C
omm
ents
fiel
d.
2.
Pr
ogre
ssio
n is
repo
rted
rega
rdle
ss o
f it o
ccur
ring
afte
r a re
spon
se (e
.g.,
Less
than
Par
tial R
espo
nse,
Par
tial R
espo
nse,
Com
plet
e R
espo
nse)
. C
larif
icat
ion
Onl
y N
ot A
pplic
able
.
3.
Th
e O
bser
ved_
Dat
e fie
ld is
man
dato
ry fo
r all
CD
US-
Com
plet
e re
spon
ses s
ubm
itted
, inc
ludi
ng S
tabl
e D
isea
se.
M
anda
tory
N
ot R
equi
red
Not
App
licab
le.
The
Obs
erve
d_D
ate
for S
tabl
e D
isea
se is
re
porte
d as
the
date
the
test
or p
roce
dure
was
pe
rfor
med
indi
catin
g th
e pa
tient
had
Sta
ble
Dis
ease
.
Trea
tmen
t Cou
rses
AE
Expe
rienc
ed F
lag
(CD
US
Not
ice
of M
odifi
catio
ns, S
ectio
n 7.
2)
1.
Th
e co
des (
1) Y
es, (
2) N
o, a
nd (3
) Too
Ear
ly to
Eva
luat
e ar
e th
e va
lid v
alue
s ava
ilabl
e fo
r the
TR
EATM
ENT_
CO
UR
SES
AE_
Expe
rienc
ed fi
eld.
The
def
initi
on o
f 'N
o' h
as b
een
refin
ed to
in
dica
te th
at th
e pa
tient
did
not
exp
erie
nce
any
adve
rse
even
ts th
at
are
requ
ired
to b
e re
port
ed v
ia C
DU
.
Cla
rific
atio
n O
nly
Not
App
licab
le.
CTE
P H
ome
Page
: http
://ct
ep.c
ance
r.gov
/ A-
6 M
ay 3
, 200
2
Rep
ortin
g R
equi
rem
ents
D
escr
iptio
n of
Cha
nge
CD
US-
Com
plet
e C
DU
S-Ab
brev
iate
d Le
gacy
Dat
a R
equi
rem
ents
C
omm
ents
Subg
roup
, Tre
atm
ent A
ssig
nmen
t Cod
es, a
nd C
orre
lativ
e St
udy
IDs
and
Des
crip
tions
(C
DU
S N
otic
e of
Mod
ifica
tions
, Sec
tion
7.3)
Su
bgro
up C
odes
, Tre
atm
ent A
ssig
nmen
t Cod
es, a
nd C
orre
lativ
e St
udy
IDs
and
thei
r des
crip
tions
are
now
ass
igne
d by
CTE
P st
aff d
urin
g pr
otoc
ol
abst
ract
ion
and
revi
ew.
Cla
rific
atio
n O
nly
Not
App
licab
le.
Afte
r pro
toco
l app
rova
l, C
TEP-
assi
gned
Su
bgro
up C
odes
, Tre
atm
ent A
ssig
nmen
t C
odes
and
Cor
rela
tive
Stud
y ID
s and
thei
r de
scrip
tions
are
subm
itted
to th
e in
vest
igat
or
and
CD
U c
onta
ct fo
r not
ifica
tion.
Subg
roup
and
Tre
atm
ent A
ssig
nmen
t Cod
es
are
sent
with
eac
h si
te’s
qua
rterly
Lis
t of
Expe
cted
Pro
toco
ls.
Smar
t Loa
der R
emin
der,
War
ning
, and
Sus
pens
ion
Proc
ess
(CD
US
Not
ice
of M
odifi
catio
ns, S
ectio
n 7.
4)
Th
e C
DU
dat
a re
subm
issi
on ti
mel
ine
was
mod
ified
to re
quire
ver
ifica
tion
and/
or re
subm
issi
on o
f file
s with
reje
ctio
n er
rors
. If n
o ve
rific
atio
n an
d/or
re
subm
issi
on is
rece
ived
by
CTE
P, th
e fo
llow
ing
corr
espo
nden
ces w
ill
occu
r: •
A re
min
der n
otic
e w
ill b
e se
nt 5
wor
king
day
s afte
r the
reje
ctio
n no
tice
is se
nt.
• A
war
ning
not
ice
will
be
sent
10
wor
king
day
s afte
r the
reje
ctio
n no
tice
is se
nt.
• A
susp
ensi
on n
otic
e w
ill b
e se
nt 1
5 w
orki
ng d
ays a
fter t
he re
ject
ion
notic
e is
sent
.
The
timel
ine
for s
endi
ng n
otic
es li
sted
abo
ve w
ill b
egin
on
the
subm
issi
on
due
date
for t
he d
ata.
If n
o fil
e is
rece
ived
for a
n ex
pect
ed p
roto
col,
then
not
ices
are
sent
ac
cord
ing
to th
e fo
llow
ing
timel
ine:
•
A la
te n
otic
e w
ill b
e se
nt 1
wor
king
day
afte
r the
due
dat
e.
• A
war
ning
not
ice
will
be
sent
10
wor
king
day
s afte
r the
due
dat
e.
• A
susp
ensi
on n
otic
e w
ill b
e se
nt 1
5 w
orki
ng d
ays a
fter t
he d
ue d
ate.
Cla
rific
atio
n O
nly
Not
App
licab
le.
Ref
eren
ce R
emov
ed (C
DU
S N
otic
e of
Mod
ifica
tions
, Sec
tion
7.5)
An
inva
lid fo
otno
te w
as re
mov
ed fr
om p
age
11 o
f the
CD
US
Inst
ruct
ions
an
d G
uide
lines
. C
larif
icat
ion
Onl
y N
ot A
pplic
able
.
Reg
iste
ring
Gro
up ID
(C
DU
S N
otic
e of
Mod
ifica
tions
, Sec
tion
7.6)
Col
lect
ion
of th
e R
eg_G
roup
_ID
was
exp
ande
d be
yond
Inte
rgro
up tr
ials
to
incl
ude
all t
rials
with
Coo
pera
tive
Gro
up p
artic
ipat
ion.
M
anda
tory
M
anda
tory
R
equi
red
for a
ll pr
otoc
ols.
CTE
P H
ome
Page
: http
://ct
ep.c
ance
r.gov
/ A-
7 M
ay 3
, 200
2
Rep
ortin
g R
equi
rem
ents
D
escr
iptio
n of
Cha
nge
CD
US-
Com
plet
e C
DU
S-Ab
brev
iate
d Le
gacy
Dat
a R
equi
rem
ents
C
omm
ents
Reg
iste
ring
Inst
itutio
n ID
(C
DU
S N
otic
e of
Mod
ifica
tions
, Sec
tion
7.7)
A W
eb si
te w
ill b
e av
aila
ble
to a
ssis
t lea
d G
roup
s in
iden
tifyi
ng th
e co
rrec
t R
eg_I
nst_
ID fo
r pat
ient
s reg
iste
red
outs
ide
the
lead
Gro
up o
n In
terg
roup
tri
als.
Cla
rific
atio
n O
nly
Not
App
licab
le.
Phas
e I E
nd P
oint
s (C
DU
S N
otic
e of
Mod
ifica
tions
, Sec
tion
7.8)
Inst
ruct
ion
for t
he P
HA
SEI_
END
_PO
INTS
tabl
e w
as m
odifi
ed to
incl
ude
colle
ctin
g ei
ther
the
reco
mm
ende
d Ph
ase
2 do
se o
r the
min
imum
eff
ectiv
e do
se d
epen
ding
on
prot
ocol
obj
ectiv
es.
Cla
rific
atio
n O
nly
Not
App
licab
le.