ae presentation and world tour-final version … clinical_research... · life threatening where can...

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Learning Adverse Events Through A World Tour

Learning Adverse Events Through A World Tour

Patty GauppBeth Ann Newman

ObjectivesObjectives

Define Adverse EventIdentify Adverse EventsUnderstand how to locate policies relatedUnderstand how to locate policies related to adverse eventsUnderstand the Elements of an Adverse Event

What is an adverse event?What is an adverse event?

An unfavorable and unintended medical experience which occurs during the clinical trial treatment period

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Key Points When Identifying Adverse Events

Key Points When Identifying Adverse Events

Note the start date of study treatmentKnow that events that occur during the course of study treatment even if they are not related to the study drug are considered adverse eventsInclude Labs and other diagnostic testingAdverse events can be symptomatic or asymptomaticA pre-existing condition that worsens during a study is also considered an adverse eventInclude concurrent condition or illness

Where can I find my Policy and or Standard Operating Procedure?

Where can I find my Policy and or Standard Operating Procedure?

MD Anderson Policy for Adverse EventsIntranetIntranet

• Human Subject Research Manual• Chapter 15

SponsorCheck sponsor policies

Critical Elements of an Adverse Event

Critical Elements of an Adverse Event

ExpectedEvent is known to occur and is listed in the protocol, informed consent, and investigator’s brochurebrochure

UnexpectedNot known to occur and is not listed in the protocol, informed consent, and investigational brochure

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Critical Parts of an Adverse EventCritical Parts of an Adverse Event

The eventStart and Stop DatesGradeRelationship to study treatmentAction TakenBaselineIntermittentComments

Critical Parts of an Adverse EventCritical Parts of an Adverse Event

• Grading- Example

Test your Knowledge-Which Grade is Temperature of 100.5˚F?

Grade 1

Common Toxicity Criteria (CTC)Common Toxicity Criteria (CTC)

What is it?A uniform system to grade adverse events

Why do we use it?Facilitate evaluation of new cancer therapies, treatment modalities and supportivetreatment modalities, and supportive measures and to standardize reporting of adverse events across groups and modalities

2 VersionsVersion 2 developed in 1982Version 3 updated in 2002

• Use version 3 with all new protocols

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Link to Online Common Toxicity Criteria

Link to Online Common Toxicity Criteria

http://ctep.cancer.gov/reporting/ctc.html

Before we begin our tripBefore we begin our trip

One more thing you need to knowAdverse Event Tracking

• Evidence must be present in medical records• A Log is always helpful

Sample LogSample Log

These columns indicate the critical elements of an Adverse Event. Can you tell me what they are?

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Case StudyCase Study

You have a patient who completed day 1 of study drug on protocol abc. Day one is today 6/1/2007. You and the Principal Investigator will be leaving Houston and t li t i t i d thtraveling to various countries around the world. In each country, you have a task to fulfill.

InstructionsInstructionsYou will have 3 minutes at each country. You will be assigned a country or station to begin with.When time is called, move to the next country or station on your listcountry or station on your list.Note the best answer possible. If you do not know the answer, ask for help or refer to your research training manual.

A Little FunA Little Fun

At the destinations, there may be a photo, a landmark, or an event which is unique to the country. If you know what it is, write it on the front of your travel kit.

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United StatesUnited StatesThe patient reported having the following event prior to receiving her first dose of study drug. Record this on your log.

Xerostomia (Dry Mouth) Grade 1Start Date: 5/30/2007Stop Date: _________Relationship to Study Med: 1. UnrelatedAction on Study Med: 1. NoneComments: Baseline Event

United StatesUnited States

Baseline Events

Adverse Event CTC Grade

Start Date StopDate

Relationship Action Comments

Xerostomia 1 05/30/2007 Unrelated None Baseline

Bon Voyage!Bon Voyage!

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Return to United StatesReturn to United States

Reminders and TipsReview your log for completion and any errors.If using a Log, remember to have PI assignattribution and sign and date.Remember patient safetyMark your CTC manual for commonly used pagesMark your CTC manual for commonly used pages or use online resources.When filling out Case Report Forms- remember to be accurate.Don’t forget your laboratory adverse events.

??Questions????Questions????Questions????Questions??

Your world tour planning experts United States Adverse Event CTC

Grade Start Date Stop Date Relationship

to Study Drug 1. Unrelated 2. Unlikely 3. Possible 4. Probable 5. Definite

Action 1. None 2. Medication 3. Procedure 4. Hospitalization

Comments

Italy Landmark ___________________________ Adverse Event CTC




Comments

India Landmark ___________________________ Adverse Event CTC




Comments

LEARNING ADVERSE EVENTS THROUGH A WORLD TOUR

Our mission is to provide you with the

most comprehensive and complete planning and travel services so that you can

have the adventure of a lifetime that is exciting, comfortable, and worry-free.

We look forward to showing you the world and teaching you a bit about adverse events along

The way.

Egypt Landmark _____________________________ ___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ Iraq Landmark _____________________________ A or B Australia Landmark _____________________________ a. _____________________________________________________________________________ b. _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ c. _____________________________________________________________________________ _____________________________________________________________________________ Brazil Landmark ____________________________ a. _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ b. _____________________________________________________________________________ _____________________________________________________________________________ c. _____________________________________________________________________________ _____________________________________________________________________________

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Serious Adverse Events

Serious Adverse Events

Cecilia Duron, RN, CCRCSr. Clinical Research Monitor

Lourdes Zanoria, RN, CCRPClinical Research Monitor

ObjectivesDefine Serious Adverse Event (SAE)Understand how to locate policies and standard operating procedures that apply to reporting SAEsId tif SAEIdentify SAEsDemonstrate documentation of the SAE in the medical recordDemonstrate the proper completion of MDACC internal SAE form

What is a Serious Adverse Event?

Any adverse experience that results in anyof the following outcomes:• Death• Life threatening• Life threatening• Hospitalization or prolongation of existing

hospitalization• Disability or incapacity• Congenital anomaly or birth defect• Medically significant

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How do I remember?Fred Doesn’t Have Any

FatalDisabilityHospitalizationAnomalyAny

Money Left

AnomalyMedically SignificantLife Threatening

Where can I find the rules?

• Human Subjects Research Manual Chapter 15

• Sponsor policiesC d f F d l R l ti d• Code of Federal Regulations and International Conference on Harmonization

This is where you can findMD Anderson Policies and Forms

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Definitions to Know

• Expected• Unexpected• Relationship

– Definite– Probable– Possible– Unlikely– Unrelated

Serious Adverse Event(SAE)

Expected Versus Unexpected• Expected

– Known to Occur and is Listed in the Investigational

• Unexpected– Not listed in

Investigational Brochure, Informed g

Brochure, Informed Consent, or General Investigational Plan

,Consent, or General Investigational Plan

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Is this a Serious Adverse Event?

• John Doe is on protocol ID-12345 and is on Day 3 of study drug.

• He has not complained of any side effects related to the drug.

• Mrs. Doe calls to report that Mr. Doe died in a car accident.

Is this an Expected Event?

Is this a Serious Adverse Event?

• Jane Smith is on Protocol 123ABC

• Yesterday she started protocol treatment

• This morning Jane was hospitalized after having two seizures

Is this an Expected Event? Where would I check?

Where do I go from here?

• Record

• Report

• File

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Record

1. Document in the medical records

2. Choose and Complete appropriate forms

Record

Death or

Serious, Unexpected, and Related

All Other Serious Adverse Events

Choose one of thePrompt Reporting Forms

1. Internal SAE2. Internal SAE Addendum3. Departmental External SAE

Choose A Log

1. Internal SAE Log2. External SAE Log

MD Anderson Prompt Reporting Timeframes

Death Within 24 Hours of awareness

Other- Serious, Unexpected Related

Within 5 working DaysUnexpected, Related, and External Death

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Reminder

• Protocol Contracts as well as Sponsors can have additional requirements regarding Serious Adverse Event ReportingReporting.– Be sure to check these for your protocols

Which Form and When?

• John Doe is on protocol ID-12345 and is on Day 3 of study drug. This is an internal protocol. There is

t id

Death or

Serious Unexpected and Related

no outside sponsor.• Mrs. Doe calls to report

that Mr. Doe died in a car accident.

• The event is unexpected and resulted in Death.

Choose one of thePrompt Forms


Which Form and When?• Jane Smith is on Protocol

123ABC which is sponsored by LM Pharmaceutical, which provides their own form.

Death or

Serious Unexpected and Related

• Yesterday she started protocol treatment

• This morning Jane was hospitalized after having two seizures. Seizures are not expected in this protocol.

Choose one of thePrompt Forms


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Prompt Reports

– Drop Box for Office of Protocol Research (OPR) is located:

• 11th floor, Faculty Center. • Sundial, 3rd floor, Main Building• Refers to all MDACC protocols• Place in envelope

– Sponsor Reporting (refer to protocol and sponsor policies)

Which Form and When?• Mark Apple is on Protocol

123456 at MD Anderson.• He was hospitalized this

morning for low hemoglobin and is

Serious Adverse Event that does not require

prompt reporting

hemoglobin and is receiving a transfusion.

• The event is listed in the investigational brochure as an expected event.

Choose A Log

1. Internal SAE Log2. External SAE Log

File

– A copy is to be maintained in the Regulatory BinderBinder

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Activity Instructions

• Split into groups • Each group will have 3 case studies

– 1 source documentation1 f diti– 1 for auditing

– 1 for SAE form completion

• Discuss findings with your team

Sample of SAE DocumentationDoll, Barbie000123

Telephone Note for protocol 2010-142312/3/2007- Received phone call from Ms. Doll at 14:32 stating she went

to New Way Hospital ER on 12/1/2007, due to complaint of extreme fatigue. She stated she was admitted to the hospital and given 2 blood transfusions. Ms. Doll stated that she felt better and was discharged home on 12/3/2007 She told me that the hospital gavedischarged home on 12/3/2007. She told me that the hospital gave her a copy of the labs results to fax to me. I provide her with my fax number. Ms. Doll last received study drug on 11/16/07 and is scheduled for follow up on 12/10/07. She was instructed to notify me of any other hospitalizations or problems that should occur before her scheduled follow up visit. Mary Jane, RN 111222

12/4/2007 @ 11:00 Received Ms. Doll’s lab results via fax and upon review, she had a Hemoglobin level on 5.0 G/DL (Grade 4) upon admission. Dr. Mathews reviewed the lab results and stated the low hemoglobin level is probably related to study drug and is not an expected adverse event, according to the protocol. Mary Jane, RN 111222

What have we reviewed?

• Definition of SAE and how to locate reporting requirements

• How to identify an SAEH t l t MDACC i t l SAE• How to complete an MDACC internal SAE form

• Document the event in medical records

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Protecting Our Information

Presented by

Information Security

Roles of Information Security

Partner with YOU to make Cancer HistoryInformation Security Teams:

Risk ManagementComputer Incident Response Team (CIRT)Information Security OperationsAccounts Management

Compliance Matrix

Map of Regulations:HIPAA, TAC 202, BPM, FDA, etc….

Map Regulations to the following:Polic for the Use & Protection of InformationPolicy for the Use & Protection of Information ResourcesInformation Resources Security Operations ManualInformation Security GuidelinesSystem Security Checklist

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Data Classification Guidelines

Data Classification Guidelines & Ratings4 Categories of Data

PublicInternal UseInternal UseConfidentialRestricted Confidential

Accessible via Information Security Department homepage

University of Texas System Policy

In June of 2004, the State Auditor’s Office (SAO) issued the following findings on the protection of research data: • Higher education institutions should do more to protect

h d tresearch data • Security of research data was inconsistent and

sometimes inadequate. • Institutions rely on decentralized departments and

individual researchers to protect research data.

Findings are tracked by the Chancellor and Audit Committee of the Board of Regents.

Lurking Threats

Tampering or theftAlteration, damage, or loss of sensitive research dataUnauthorized access or use of sensitive research dataese c dImproper disposal of digital media containing sensitive research data Sharing passwords and/or system access codes Unauthorized release of sensitive research data or product information, on or off the campus

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Adverse Impact of Poor Research Data Security

Increased legal liability

Loss of revenue, grants, gifts, and donations

Loss of data, information resources related assets, and productivity

Injury to Researcher and M. D. Anderson reputation, bad publicity

Loss of public trust

Default on project(s)

Increased regulation, sanctions and/or legislation

Meeting Requirements

Our challenge is to safeguard Research Data while meeting the requirements of:

Federal research grants, Regulations related to the Responsible g pConduct of ResearchScientific journals.

UTS 165 Research Policy Objectives

Protect the confidentiality and integrity of research data without creating unjustified obstacles to the conduct of research activitiesresearch activities

Establish accountability.Identify sensitive research data based on RiskProtect confidentiality and integrity of research data in accordance with M. D. Anderson Policies and Procedures

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Research Data

Research Data: Recorded information, regardless of form or media in which it may be recorded, which constitute the original observations and methods of a study and the analyses of such original data that are necessary to support Research activities and validate Research findings. Research Data may include but is not limited to: printed records, observations and notes; electronic data; video and audio records, photographs and negatives, etc

UTS 165 Policy Components

5. 2.

1. Accountability

Training andAwareness

4.Security

Safeguards

3. Access Control

DataClassificationProtection of

DigitalResearch Data

Roles & Responsibilities

Each Lead Researcher is responsible for implementing this UTS for all Digital Research Data that is under that Lead Researcher’s control.

Researchers and all others that assist in the Research performed at M. D. Anderson will comply with this UTS and protect Sensitive Digital Research Data with security safeguardsSensitive Digital Research Data with security safeguards

Internal Audit, or a similar function, will monitor the implementation of and compliance with the provisions of this UTS at M. D. Anderson

Information Security, shall provide support, guidance and problem resolution to the UT Institution’s Lead Researcher’s and Researchers with respect to this UTS and M. D. Anderson’s applicable policies and procedures.

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Lead Researchers’ responsibilities

Lead Researchers should manage and monitor access to Sensitive Digital Research Data under their control based on sensitivity and risk and should secure it appropriately (Section 3.1.1)For example:

P id t S iti Di it l R h D t d tProvide access to Sensitive Digital Research Data on a need to know basis.

Use the M. D. Anderson issued identity credentials and Access Management procedures to provide access to computer systems, databases, web applications, etc.

Use Virtual Private Network (VPN) or Terminal Services for secure remote access to M. D. Anderson’s computer systems when access is required from off-campus.

Protect Digital Research Data

A good “Rule of Thumb” is to identify and classify Digital Research Data for which one or more of the following are REQUIRED:

Need for ConfidentialityNeed for Confidentiality

Need for Integrity

Need for Availability

Access Control

Protect Sensitive Digital Research Data from casual viewing by othersKeep people away from your equipment and Sensitive Digital Research Dataand Sensitive Digital Research Data.Use strong passwordsLaptop security

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Are you a Computer Hacker’s Target?

Be suspicious if anybody asks you for:Your password, credit #Be suspicious if anybody calls you claiming to represent executive management and asks for confidential informationconfidential informationBlogging –Vehicle for Industrial EspionageBeware of unsolicited technical adviceDumpster divingBe cautious of downloading software from questionable sources

Protect Sensitive Research Data

The following is a representative checklist:Regularly or automatically upgrade and patch Operating Systems,Back up Sensitive Research Data regularly and ensure that it can be reliably restoredand ensure that it can be reliably restored, Use Anti-Virus and Firewall softwareRevision and Change Control procedures for significant changes

Research Source-Data Acquisition

FaxMailPhoneemailPaper RecordsManual data entry from another applicationAutomated import from another applicationTransportable Media

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Protection During Transmission

To protect the security of Sensitive Digital Research Data during electronic communications or transmissionsUse Secure File Transfer Protocol (SFTP)Use encrypted emailUse encrypted emailDo not use non-M. D. Anderson email accounts (e.g. Yahoo, Hotmail)Are only M. D. Anderson approved wireless networks used?

Reduce the Use and Collection of SSN (UTS 165 Section 10)

Discontinue the use of SSN as an individual’s primary identification number unless required or permitted by lawInform individuals when the Institution collects SSNs – provide Voluntary Disclosure NoticeProhibit the sending of SSN over the Internet or by email unless encryptedLimit Access to records containing SSNs to employees with a business need to knowProtect SSNs with security safeguards

Reduce the Use and Collection of SSN #2

Protect the security of records containing SSN during storage.Conditions for sharing SSN with third partiesDisposal of records containing SSNDisposal of records containing SSNDatabase containing SSN must not use SSN as the primary key to a databasePersonnel training – Education Center training moduleRequires employees to report inappropriate disclosure of SSN

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Training & Awareness

Encourage and nurture the growth of information resources security.

FDA Regulated Activities

Subject of 21CFR Part 11 ComplianceElectronic Records:• Confidentiality, • Integrity and,

A il bilit• Availability

Electronic Signatures:• Non-repudiation

Security Risk Assessment

21CFR Part 11 Compliance

Includes:Institution-wide applications such as Clinic Station, PDMS, etcSpecific departmental applications such as T t d M iTracemaster and MosaiqApplications used by individual investigators

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What is a Security Risk Assessment?

To determine the quantitative or qualitative value of risk related to a concrete situation and a recognized threat.MDACC utilizes the qualitative risk assessmentqprocess to provide a measurement of applications and processes in compliance with policy, certifications and laws.

Why are Risk Assessments done?

To protect patient informationTo protect research information To protect the assets of the University of Texas M. D. Anderson Cancer CenterM. D. Anderson Cancer CenterTo ensure applications and supporting infrastructure is meeting regulatory and policy requirementsTo assist project teams with building state, federal, University of Texas and M. D. Anderson security policy requirements into the project

Types of Risk Assessments

Security Risk Assessment• Full Security Risk Assessment of Applications and

Systems

Security Self Assessment (Spreadsheets, etc)• Research Security Check ListResearch Security Check List• Walks one through the Lifecycle of Data Security

o Acquisition, o Storage, o Sharing/Transmission/Sendingo Backup and Recoveryo Disposal

• http://inside.mdanderson.org/departments/infosec/security-resources.html

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NIH Application/System Security Plan (SSP)

National Institute of Health Application/System Security Plan (SSP) Template for Applications and General Support SystemsInformation Security Department has completed the general security informationSystem-specific answers have been left blank http://inside.mdanderson.org/departments/infosec/security-resources.html

Useful Websites

http://onguardonline.gov/index.htmlhttp://irm.cit.nih.gov/security/security-communicating.htmhttp://securitynews.nih.gov/phishing alert.dochttp://securitynews.nih.gov/phishing_alert.dochttp://inside.mdanderson.org/departments/infosec/security-resources.html

How do I contact Information Security?

Most important – (713) 745-9000• Easy to remember – 5-9000

Learn more on our website• inside mdanderson org/infosec• inside.mdanderson.org/infosec

Email us at [email protected] – (713) 745-4118Stop by our office at FBB 2.250

ae presentation and world tour-final version … clinical_research... · life threatening where can...

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