university of florida health cancer center new investigator welcome packet · 2020-04-10 ·...
TRANSCRIPT
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University of Florida Health Cancer Center
New Investigator Welcome Packet
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Table of Contents Getting Started .......................................................................................................................................................... 4
Privacy Training: HIPAA ........................................................................................................................................ 4
Good Clinical Practice (GCP) Training ................................................................................................................... 4
Cancer Therapy Evaluation Program (CTEP): Registration and Credential Repository (RCR) ............................ 4
Institutional Review Board Training ..................................................................................................................... 5
Apply for UF Health Cancer Center Membership ................................................................................................ 5
Research Oversight System ...................................................................................................................................... 6
Disease Site Groups (DSG) .................................................................................................................................... 6
Scientific Review and Monitoring Committee (SRMC) ........................................................................................ 6
Institutional Review Board (IRB) .......................................................................................................................... 7
Data Integrity and Safety Committee (DISC) ....................................................................................................... 7
Study Activation Process .......................................................................................................................................... 8
Contracts & Budgets ................................................................................................................................................. 9
Cooperative Group Trials vs. Industry Sponsored Trials vs. Investigator Initiated Trials .................................. 9
Medicare Coverage Analysis ................................................................................................................................. 9
The Office of Clinical Research (OCR) ................................................................................................................... 9
University of Florida Division of Research Operations & Services - Conflict of Interest .................................. 11
Data Reporting Requirements ............................................................................................................................ 11
IIT Project Management ......................................................................................................................................... 12
Concept Development Group (CDG) Pre-Review Process ................................................................................. 12
Protocol Development, Activation and Management....................................................................................... 13
Research Support Services ..................................................................................................................................... 14
Biostatistics & Quantitative Sciences Shares Resource (BQS SR) ..................................................................... 14
Cancer Population Sciences Navigator ............................................................................................................... 14
Clinical Trials Auditing and Monitoring .............................................................................................................. 14
Cooperative Research and Consortiums ................................................................................................................ 15
New Cancer Investigator Training Checklist .......................................................................................................... 17
UFHCC Disease Site Group: Documentation of Membership ................................................................................ 19
New Cancer Clinical Investigator – Recommended Training ................................................................................. 20
Guidance: Investigator Oversight & Responsibility ............................................................................................... 21
How to Access Online GCP Training through CITI .................................................................................................. 24
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Introduction
Welcome to the UF Health Cancer Center. We are dedicated to providing the residents of Florida with leading-edge cancer care and conducting original research for the prevention, early diagnosis and treatment of cancer.
Cancer is the leading cause of death for Floridians. Our state has the second highest cancer mortality rate in the nation, and the age group at the highest risk of developing cancer — 65 and older — is projected to grow by 25 percent over the next two decades. Therefore, our efforts to serve Florida with innovative research and leading cancer care have never been more critical.
By leveraging all the resources of the University of Florida campus, the UF Health Cancer Center stands alone in the state in our unique ability to blend comprehensive patient care and innovative research in a collaborative, multidisciplinary environment. We participate in research that has a direct impact on improved patient outcomes, allowing patients access to the very latest cancer fighting technologies and drugs. Our clinical enterprise uses a comprehensive care model, with multidisciplinary cancer programs offering advanced treatment options such as minimally invasive and robotic surgery, proton and intensity-modulated radiotherapy, hematopoietic stem cell transplantation, chemotherapy, targeted therapy and immunotherapy in conjunction with precision medicine, as well as access to clinical trials.
The UFHCC catchment area is comprised of 22 counties with high rates of cancer and cancer risk factors, including smoking, among residents who face disadvantages due to race/ethnicity, poverty, rurality, older age and poor health literacy. To address the health challenges specific to the UFHCC catchment area, and to better understand contributors to the burden of cancer, UFHCC Investigators are engaged in population-based and cancer control research through the Cancer Population Sciences division.
The mission of the UFHCC Clinical Research Office (CRO) is to help deliver new and promising cancer treatments in order to improve the lives of the patients at the UF Health Cancer Center. The UFHCC CRO provides support to UF Health Cancer Center investigators for the development and implementation of cancer clinical trials. The primary goal of the UFHCC CRO is to facilitate the conduct of high-quality clinical research while adhering to the highest ethical standards and maintaining compliance with all governing bodies. The UFHCC CRO can assist investigators with protocol development, startup and activation, regulatory affairs, subject screening and recruitment, clinical research coordination, data abstraction, information dissemination and serving as liaison with sponsors and regulatory bodies. The CRO also provides quality assurance, education and training to bolster data integrity and subject safety.
The UFHCC has implemented several policies and procedures to guide and prioritize cancer relevant research. This document will introduce materials relevant to investigators and research staff, to the processes and committees involved in the conduct of research studies associated with the UFHCC.
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Getting Started The following training and/or registrations are required for all investigators BEFORE engaging in any clinical research activities associated with the UFHCC.
Privacy Training: HIPAA If you have not already done so, please complete the HIPAA & Privacy – General Awareness Training at: http://mytraining.hr.ufl.edu/ (Course#: PRV800)
Good Clinical Practice (GCP) Training Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the performance of a clinical research trial. The principles of GCP help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting. GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical research. All individuals who are involved in clinical trials with the UFHCC CRO must complete GCP Training every 3 years (or earlier if the Certificate of Completion notes an earlier expiration).
CITI GCP Training can be accessed through the myUFL portal.
• https://my.ufl.edu > Main Menu > My Self Service > Training and Development > CITI Training > Agree to Continue to CITI
• Once on the CITI site, select UF Courses > Under My Learner Tools for UF select “Add a course” • Scroll down to Question 5 and select: CITI Good Clinical Practice Course
Email certificate of completion to [email protected]
Step-by-step instructions are available on the UFHCC CRO Website.
Cancer Therapy Evaluation Program (CTEP): Registration and Credential Repository (RCR) All clinical investigators, will need to obtain a CTEP Identity and Access Management (CTEP-IAM) Account. If you are population science (CPS) investigator, please email [email protected] to determine if a CTEP-IAM account will be required. Until you have an active CTEP registration within the UFHCC Portfolio, you will not be able to participate as a Principal Investigator or Sub-Investigator for trials associated with the NCI NCTN Cooperative group (SWOG, ECOG-ACRIN, ALLIANCE, COG, NRG, etc. type groups.)
• Step 1: o If you already have an NCI# or CTEP registration, ensure that log in is available in the RCR
system: https://www.ctepcore.nci.nih.gov/iam/index.jsp > Reset Password, if needed.
(CTEP instructions continued on next page…)
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o If you have not previously registered with CTEP and/or obtained an NCI#, go to:
https://www.ctepcore.nci.nih.gov/iam/index.jsp Request New Account Complete Registration request Obtain NCI#.
RCR Registration Requirements:
• Step 2: Email the following documents and/or questions to [email protected]: o NCI # (This number can be found in CTSU.org>my Account or by the UFHCC CRO
Regulatory Team); o GCP Certificate of Completion; o Signed and dated CV, updated to reflect current role(s); o A copy of your medical license.
• Step 3: Additional updates will be made to your Registration Packet by the UFHCC Core
Regulatory Staff. Once complete, you will be contacted to review, sign and submit the registration at: https://ctepcore.nci.nih.gov/rcr/lsUsersrc.action
For any questions or help with completing your CTEP-IAM registration, email [email protected] or [email protected] for assistance.
Institutional Review Board Training If you are involved with research with human subjects, human tissue and/or specimens, or data, you must complete all training required by the UF IRB-01: http://irb.ufl.edu/index/requiredtraining.html
Apply for UF Health Cancer Center Membership UF Health Cancer Center (UFHCC) membership is required for all University of Florida investigators holding a faculty appointment and actively engaged in, or who demonstrate interest in, cancer-focused basic, clinical, translational, and population-based research. UFHCC members are dedicated to providing leading-edge cancer care and conducting original research for the prevention, early diagnosis and treatment of cancer. Eligibility and privileges are based on individual’s current level of cancer-focused research and affiliation with UFHCC.
Applications for and additional information regarding UF Health Cancer Center Membership can be found on the UFHCC Members Overview webpage.
Contact: [email protected].
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Research Oversight System The Research Oversight System helps to facilitate high-quality research, while adhering to the highest ethical standards and maintaining compliance with all governing bodies.
Disease Site Groups (DSG) The UFHCC DSGs are the units whereby research portfolios are organized, managed, and executed. DSGs are both disease specific (e.g., thoracic, breast, or gynecological) and disease agnostic (e.g., experimental therapeutics group or cancer population sciences). Each DSG is charged with developing and maintaining a portfolio of trials that brings forward scientific hypotheses developed in the UFHCC Research Programs, meets the needs of our patient population without unjustified competition or overlap, and successfully reaches the study accrual goals. All new interventional trials must be reviewed and approved by the applicable DSG prior to SRMC submission. DSG approval attests to the projected annual accrual, allocation of UFHCC CRO resources, presence or absence of competing studies, and overall endorsement of support from the group. In addition, the DSGs are responsible for evaluating the impact of the proposed study on the patient population at UF Health and/or the UFHCC catchment area.
A list of current DSGs, contact information for DSG Research and Clinical leaders, as well as the DSG Submission Form can be found on the UFHCC CRO Website.
Contact: [email protected]
Scientific Review and Monitoring Committee (SRMC) SRMC is responsible for reviewing the scientific merit, methodology, validity of statistical analyses, and adequacy of the protocol-specific data safety monitoring plan (DSMP), as well as assessing project feasibility, risk level, and determining the scientific priority of appropriate studies. All cancer-relevant studies conducted at the UFHCC or supported with institutional resources, and meeting review requirements (see SRMC Manual) must be reviewed and approved by the SRMC prior to study initiation.
The UFHCC SRMC ensures prioritization of studies and monitors all cancer-relevant studies for expected progress relating to accrual goals and performance standards. In this capacity, the SRMC has the authority and charge to close any study failing to meet accrual goals. Additionally, they may require change to or closure of trials that have become obsolete by new advances in the field and, therefore, whose scientific rationale has become superseded by changes in clinical practice.
SRMC works closely with the Data Integrity and Safety Committee (DISC) to ensure the scientific integrity of investigator-initiated research conducted through the UFHCC while ensuring the safety and rights of research participants.
Contact: [email protected]
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Institutional Review Board (IRB) UF researchers work with several IRBs that are responsible for the ethics review of all research that involves human subjects. There are two local IRBs on the health science center campus (IRB-01 and -02). In addition, researchers may also submit to the Western IRB, and/or utilize the ceded IRB process.
The IRB review focuses on study ethics and subject safety, and their assessment is separate, but complimentary, to the roles of the SRMC and DISC.
Additional information regarding the UF IRBs can be found at: www.irb.ufl.edu
Data Integrity and Safety Committee (DISC) The DISC serves as the independent committee charged with review of interventional Investigator Initiated Trials (IITs) that do not have an external SRMC-approved DSMB. The DISC concentrates on the review of safety, Adverse Events, Unanticipated Problems, study endpoints, protocol compliance, and data integrity. Some cooperative group, industry-sponsored, and other studies with an established SRMC approved DSMP/DSMB are not subject to DISC oversight.
Contact: [email protected]
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Study Activation Process The figure below provides an overview of the steps involved in the protocol start up process:
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Contracts & Budgets Conducting clinical research is a resource intensive endeavor; contracts and their associated budgets are an integral mechanism for obtaining sufficient funding to support a clinical research study.
Cooperative Group Trials vs. Industry Sponsored Trials vs. Investigator Initiated Trials Federal cooperative group trials are generally conducted under a master contract that covers the conduct of all trials from that cooperative group. While often limited contractual work is required prior to initiation of these studies, the budgets are generally nonnegotiable and often do not fully cover the costs of conducting the trial. Examples of Cooperative Group trials include those found on the CTSU.org website: NRG, Alliance, SWOG, ECOG-ACRIN, COG, ETCTN, etc.
Generally, for industry-sponsored trials, the Sponsor will provide a budget that fully covers the estimated cost of conducting the trial at UFHCC. The Office of Clinical Research (OCR) Coverage Analysis and Budgeting Team is available to help research teams develop and/or negotiate clinical research budgets to come to an agreement on funding. Examples of industry sponsors include: AbbVie, Merck, Inc., Pfizer, etc. All contracts are executed through the OCR and the Division of Sponsored Research (DSP).
Funding for investigator-initiated studies (IITs) can come from a variety of sources, including federal or foundation grants, pharmaceutical collaborations, philanthropic funds, etc. IITs are considered integral to our mission and the UFHCC CRO Project Management Office (PMO) is available to help design IITs and assist in identifying sufficient funds to enable study conduct.
Medicare Coverage Analysis An important aspect of contract and budget development is a Medicare Coverage Analysis. This analysis helps to determine which protocol-required procedures can be billed to the subject’s insurance. While UFHCC and CRO staff will consult National Comprehensive Cancer Network (NCCN) guidelines to help justify whether a procedure is considered “standard of care” or “routine cost”, PI’s may need to assist in these determinations and/or provide peer-reviewed literature as evidence of the standard practice for a particular disease.
The Office of Clinical Research (OCR) The OCR uses a team-based approach to facilitate research and collaboratively problem-solve the issues that can arise during trial start-up and conduct. OCR support teams can provide assistance with the following activities:
Budgeting The OCR Coverage Analysis and Budgeting Team is available to help develop and/or negotiate clinical research budgets
Contact: [email protected]
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Contracting The OCR Contracting team represents the University of Florida in the preparation, negotiation, and activation of all sponsored agreements and Confidentiality Disclosure Agreements (CDAs), sub-awards and other contractual agreements under the purview of the OCR.
Contact: [email protected]
ClinicalTrials.gov Facilitation The UF ClinicalTrails.gov program was developed to improve UF clinical research processes and ensure compliance with ClinicalTrials.gov federal registration, record maintenance, and result-reporting requirements
Contact: [email protected]
Intellectual Property Protection Patentable inventions and other marketable forms of intellectual property may result from research conducted by personnel of the University. The OCR Contracting team represents the University of Florida in the preparation, negotiation, and activation of all sponsored clinical research agreements. These agreements often include intellectual property language terms and conditions.
Contact: [email protected]
OnCore & Study Participant Management OnCore is a web-based clinical trial management system that manages multiple aspects of clinical research, including protocols, participants, sponsor invoicing, data, and specimens. The OCR OnCore Support team provides OnCore training and consults, along with customer support though telephone/email conversations or the OnCore web-based self-service ticket system.
Contact: [email protected]
Sponsor Invoicing & Receivables The OCR Financials team is responsible for invoicing industry clinical research sponsors and managing Accounts Receivable for 214-Fund industry-funded clinical research studies.
Contact: [email protected]
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University of Florida Division of Research Operations & Services - Conflict of Interest The UF Division of Research Operations and Services (DROS) mission is to facilitate research within applicable regulatory requirements, including ensuring that all identified individual and institutional conflicts of interest are appropriately, managed, reduced or eliminated.
The UF Conflict of Interest (COI) policy, training and forms can be found on the DROS website: http://research.ufl.edu/research-operations-services/conflict-of-interest-and-outside-activities.html
Contact: Mike Scian – Assistant Direct & COI Administrator, Research Operations and Services
Data Reporting Requirements The UFHCC is responsible for reporting information about protocol activity to the National Cancer Institute (NCI), as well as other federal and state agencies. It is critical that information be timely and accurate. To this end, all study status and accrual information must be entered into OnCore, the Cancer Center’s Clinical Trials Management System (CTMS). Reporting requirements will vary dependent upon the type of the study (e.g. interventional, observational, ancillary, etc.) as well as whether or not a trial is under DISC oversight. Regardless, it is the responsibility of the Principal Investigator (PI) and their research staff to ensure that reporting is in compliance with UFHCC Standard Operating Procedure (ADM-004).
Expectations and instructions for required data reporting can be located on the UFHCC Research Policies and Helpful Documents webpage.
Contact: Ashley Anderson – Assistant Director, Clinical Research Administration & Compliance
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IIT Project Management UF Investigator-Initiated Trials (IITS) are trials that are proposed, written, and developed by UF Investigators. IITs are institutional priorities, and the UFHCC Project Management Office (PMO) provides concept development support as well as protocol development, activation and management support to Investigators interested in developing an IIT. If you are a CPS Investigator, similar support is provided to you through the CPS Navigator service – more information can be found on the CPS Navigator website: https://cancer.ufl.edu/research/research-support/cps-navigator/.
Concept Development Group (CDG) Pre-Review Process The UFHCC has a pre-review process for all cancer-relevant IIT’s categorized as “interventional treatment” or otherwise involving investigational drugs, devices or medical procedures. This review by the Concept Development Group (CDG) is required for any IIT planning to utilize UFHCC CRO resources. CRO resources include PMO services, dedicated Coordinator or data entry support, regulatory management, monitoring oversight, financial or other in-kind support. If you are a CPS investigator, please contact the CPS Navigator to better determine if your trial would require CDG review.
The aims of CDG review is to:
1. Improve the feasibility, scientific merit and ultimate success of the IIT 2. To expedite the startup process 3. To maximize staff and investigator effort in protocol
Protocol concepts must be first endorsed by the respective DSG research leader, and the endorsed pre-review form should then be submitted to [email protected]
Contact: Erin Monari – Protocol Development Manager
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Protocol Development, Activation and Management Once a project has been approved by the CDG, the UFHCC Project Management Office (PMO) can assist with the further development and execution of the trial. PMO resources are limited and will be assigned by the Director of the Clinical Research Office based upon the CDG approval and prioritization score. Requests for PMO development, activation and management services should be submitted via the CRO IIT Project Management Services Request Form on the UFHCC CRO Website.
PMO Protocol Development support can include but is not limited to:
• Protocol and Informed Consent Form authoring • Assistance with FDA IND/IDE document submission • Assistance with study submission to the Feasibility Group, DSG, SRMC, IRB, DISC and
ClinicalTrials.gov • Case Report Form design • Assisting with funding submissions • Facilitation of bio statistical support
PMO Activation and Management Support can include but it not limited to:
• Conduct initial protocol training for Principal Investigator and applicable study staff • Manage Protocol amendments (including revisions and clarification memos) and Informed
Consent Form revisions • Triaging and archiving of all communications with external collaborators • Maintenance of protocol records within ClinicalTrials.gov, etc.
A full description of PMO Project Development, Activation and Management services can be on the UFHCC CRO Website: https://cancer.ufl.edu/wordpress/files/2019/02/IIT-Process-v3-2018-06-14.pdf
Contact: Alisha Daniels – Assistant Director of Project Management and Regulatory
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Research Support Services
Biostatistics & Quantitative Sciences Shares Resource (BQS SR) As a part of the Division of Quantitative Sciences, BQS SR provides statistical and analytic collaborative support to UF Health Cancer Center members for short and moderate term projects, including the development of research projects. BQS SR Services include assistance with research project conceptualization, study design, basic data management, and statistical analyses and interpretation.
A full description of the services and support provided by BQS SR, as well as instructions for how to request support services can be found on the UFHCC CRO Website: https://cancer.ufl.edu/research/shared-resources/biostatistics-core/
Contact: Ji-Hyun Lee, DrPH – Director of the Division of Quantitative Services.
Cancer Population Sciences Navigator The CPS Navigator acts as a resource for CPS investigators and their study teams, providing assistance with navigating study activation and ongoing review processes. Based within the UFHCC Clinical Research Office, the CPS Navigator is available to assist CPS investigators navigate the required regulatory and ancillary committee reviews, assist in developing effective recruitment and accrual plans, and connect investigators and study teams with resources available within the community and the UFHCC.
A full description of the services and support available through the CPS Navigator can be found on the UFHCC Research Support webpage.
Contact: [email protected]
Clinical Trials Auditing and Monitoring The Clinical Trials Auditing and Monitoring Team (CTAT) provides ongoing auditing for a myriad of trial designs. Audits may be conducted randomly or for cause, and are intended to evaluate overall study conduct and compliance with the protocol, effectiveness of current training, education and monitoring practices. For additional information regarding this process, please refer to the UFHCC Clinical Trial Audit Manual, found on the UFHCC Website.
Contact: [email protected]
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Cooperative Research and Consortiums Cooperative research groups and consortiums provide a larger network of physicians, research professionals and resources, all with a shared goal to conduct original research for the prevention, early diagnosis and treatment of cancer. The UFHCC memberships include (but are not limited to) the following groups:
Blood and Marrow Transplant – Clinical Trials Network (BMT-CTN) The BMT CTN was established in October 2001 to conduct large multi-institutional clinical trials to address important issues in hematopoietic stem cell transplantation (HSCT), thereby furthering understanding of the best possible treatment approaches.
NRG Oncology NRG Oncology is a non-profit research organization formed to conduct oncologic clinical research and to broadly disseminate study results for informing clinical decision making and healthcare policy. It brings together the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG)
Children’s Oncology Group (COG) The Children’s Oncology Group is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. COG unites over 10,000 research experts in childhood cancer from around the world in our efforts to understand the causes of cancer and find more effective treatments for the children we care for.
Academic and Community Cancer Research United (ACCRU) ACCRU is a cancer research network that includes clinicians and researchers from more than 110 leading academic medical centers and community oncology practices in the United States and internationally.
Gynecologic Oncology Group (GOG) Foundation The GOG Foundation, Inc. (GOG Foundation) is an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The mission of the GOG Foundation is to conduct clinical and translational research that positively impacts women through the prevention and treatment of gynecologic malignancies.
National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation The Mission of NSABP Foundation, Inc. is to design and conduct practice changing cancer research, including clinical trials and laboratory studies in the medical, surgical and prevention settings in order to improve the survival outcome and quality of life of patients with breast and colorectal cancer, and to disseminate the results of NSABP collaborative research to benefit the worldwide community.
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Contact Us
Full contact information for the UFHCC CRO can be found on our website: https://cancer.ufl.edu/
UF Health Cancer Center Clinical Research Office
P.O. Box 103633 Gainesville, FL 32610-6366
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New Cancer Investigator Training Checklist UF Health Cancer Center Clinical Research Office
INSTRUCTIONS: Please ensure that the following items are completed and all applicable certificates of completion and/or requested documents are submitted to the listed contact BEFORE engaging in any clinical research activities associated with the UFHCC. (Examples include but are not limited to: obtaining informed consent or signing off on drug orders.)
Training Task Date Completed
Privacy Training: HIPAA & Privacy – General Awareness (PRV800) (~25-30 minutes) myUFL > My Self Service > Training and Development > myTraining
Email certificate of completion to [email protected]
Good Clinical Practice (GCP) Training (~4 – 6 hours – does not need to be completed in one sitting) myUFL > My Self Service > Training and Development > CITI Training > Agree to Continue to CITI > Click on Main Menu > Select UF Courses > Under My Learner Tools for UF select Add a Course > scroll down to Q5 > select CITI Good Clinical Practice Course > Submit
Email certificate of completion to [email protected]
Register with Cancer Therapy and Evaluation Program (CTEP) / Obtain a CTEP-IAM account (If you are a CPS investigator, please contact [email protected] to determine if a CTEP-IAM account is necessary.) Step 1: Obtain NIH IAM account: https://ctepcore.nci.nih.gov/rcr Request New Account obtain NCI #
Step 2: Email the following documents to [email protected] : • NCI # (this can be found in CTSU.org > my account) • GCP Certificate of Completion • Signed and dated CV – updated to reflect current role(s) • A copy of your medical license
Step 3: Additional updates will be made to your Registration Packet by the UFHCC Core Regulatory Staff. Once complete, you will be contacted to review, sign and submit the registration at: https://ctepcore.nci.nih.gov/rcr/lsUsersrc.action
As applicable, request addition to applicable NCTN Cooperative Groups Before enrolling subjects on cooperative group trials, you must be credentialed and added to the appropriate Cooperative Group roster, please email [email protected] or the appropriate area manager for assistance:
• Blood and Marrow Clinical Trials Network (BMCTN) – Christina Cline ([email protected])
• NRG Oncology - Tonia Toon ([email protected]) or Alison Ivey ([email protected]) • Children’s Oncology Group (COG) – Gigi Moore Higgs ([email protected])
UF Health Cancer Center Clinical Research Office
P.O. Box 103633 Gainesville, FL 32610-6366
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Investigator Name Signature and Date
Verification of completion of training by the Associate Director of Clinical Research is required for all individuals planning to serve as Principal Investigator on a Clinical Trial facilitated through the UFHCC.
Associate Director for Clinical Research, Date UFHCC
Please send completed checklists to [email protected] and [email protected].
Complete COI Training and Submit COI Forms per the UF Division of Research Operations and Services Website: http://research.ufl.edu/research-operations-services/conflict-of-interest-and-outside-activities.html
IRB Training (IRB803) (~30 minutes) myUFL > My Self Service > Training and Development > myTraining
Register for a myIRB account https://myirb.ufl.edu
Confirm membership within applicable Disease Site Group(s). Before engaging in any research activities, you must be added to each applicable Disease Site Group (DSG). A complete list of DSGs and their Leaders can be found online at: https://cancer.ufl.edu/research/clinical-trials-office-2/disease-site-groups/
Please provide signed DSG Membership Documentation Form(s) to [email protected] and [email protected] to initiate addition to the relevant study teams.
Complete UFHCC Membership Application Website: https://cancer.ufl.edu/members/membership-application/uf-health-cancer-center-membership-application/
For assistance email [email protected]
If dual appointed with the Malcom Randall VA Medical Center, and interested in participating in research performed at the VA, contact Theresa Smith ([email protected]) www.nffre-research.org .
Addition to existing IIT’s performed at the VA will be managed by the Project Management Office ([email protected])
If you need to transfer a research grant from another institution contact UFHCC Grant Support at [email protected] for assistance.
UF Health Cancer Center Clinical Research Office
P.O. Box 103633 Gainesville, FL 32610-6366
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UFHCC Disease Site Group: Documentation of Membership This form serves as documentation that the DSG Research leader indicated has reviewed with the Investigator
expectations for DSG membership, the schedule for applicable DSG/Tumor Board meetings, and a review of current and upcoming trial discussions and/or recruitment issues.
Please return signed form(s) to [email protected] and [email protected].
DSG Research Leader Contact Information
Gastrointestinal Thomas George, MD, FACP [email protected] (352) 273 – 6900
Genitourinary Paul L. Crispen, MD [email protected]
(352) 265 - 8240
Thoracic Fredric J. Kaye, MD [email protected] (352) 273 - 7766
Gynecologic Merry Jennifer Markham, MD [email protected]
(352) 273 - 7832
Sarcoma / Cutaneous Christiana M. Shaw, MD [email protected] (352) 265 – 0761
Breast Karen Daily, DO [email protected]
(352) 273-7832
Neurology David Tran, MD [email protected] (352) 273 - 9000
Head and Neck Natalie L. Silver, MD, MS [email protected]
(352) 273-5199
Hematologic Malignancies Nosha Farhadfar, MD [email protected]
Pediatrics Sridharan Gururangan, FRCP
(Edin.) [email protected] (352) 273 - 9000
Experimental Therapeutics Group
Thomas George, MD, FACP David DeRemer, Pharm.D., FCCP, BCOP
[email protected] (352) 273 – 6900 [email protected] (352) 294 – 8891
Cancer Population Sciences Diana Wilkie, Ph.D, RN, FAAN Janice Krieger, Ph.D
[email protected] (352) 273 – 6401 [email protected] (352) 273 - 0240
DSG Research Leader Printed Name Signature and Date
____________________________________ _______________________________________ New Investigator Printed Name Signature and Date
UF Health Cancer Center Clinical Research Office
P.O. Box 103633 Gainesville, FL 32610-6366
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New Cancer Clinical Investigator – Recommended Training UF Health Cancer Center Clinical Research Office
The following trainings and reading are HIGHLY RECOMMENDED by the UFHCC Clinical Research Office and are available at no cost, online or through the UF Health e-learning platform: myTraining.
Sponsored Projects Overview An introductory course designed to provide a “big picture” view of the University of Florida’s research enterprise. This session discusses UF’s mission with a special focus on the Research component. It also covers UF’s organization structure, the role of the research administrator, and the importance of maintaining our “culture of compliance.”
Course #: UF_RSH_100_OLT
Financial Conflict of Interest This course features updated information related to the National Institute of Health regulations. A conflict of interest, in basic terms, is described as a situation in which a person serves or represents two distinct entities (or persons) and must choose between two conflicting interests.
Course #: UF_DSR810_OLT
CTSI Informed Consent Training Obtaining informed consent from each potential subject is required by law before a person may participate in a clinical study. This training is intended to give research team members certain skills when designing, constructing and obtaining an informed consent.
Course #: UF_CTS800_OLT
Investigator Responsibility of Informed consent
It is the responsibility of the Investigator to ensure that all aspects of a clinical trial are carried out in a safe and ethical manner, while maintaining compliance with federal, state, and local regulations. A cornerstone of these activities is the informed consent process. This training reviews the process for teaching, training, and supervising those who will be responsible for obtaining informed consent.
Pre-requisites: CTS800 CTSI Informed Consent Training
Course #: UF-CTS801_OLT
Clinical Trial Endpoints for the Approval Cancer Drugs and Biologics: Guidance for Industry Provided by the FDA, this guidance provides recommendations on endpoints for oncology clinical trials submitted to the FDA, and provides background information and discusses general regulatory principles
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Guidance: Investigator Oversight & Responsibility
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How to Access Online GCP Training through CITI
Log into MyUFL (www.my.ufl.edu) and navigate to the main menu, by selecting the menu icon in the top right corner.
1. Select “My Self Service” from the 2. Select “Training and Development” Main Menu from the Self Service Menu
3. Then select “CITI Training” and follow the prompts to continue to the CITI Website.
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Once you’ve logged on to the CITI website from myUFL, you will see a welcome screen similar to this:
Select “View Courses
Select “Learner Tools”
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You will see a page like this:
Select “Add a Course”
SCROLL DOWN TO QUESTION #5
Do not answer Questions 1 -4
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Select “CITI Good Clinical Practice Course”
Select: not at this time
Scroll down to SUBMIT
For questions 7, 8 and 9 select: “Not at this time”