Investigator's Handbook
A Manual for Participants in Clinical Trials of Investigational Agents Sponsored by DCTD, NCI
Part D: The Organization of a Clinical Trial
13. Affiliate Investigators
13. Affiliate Investigators
The participation of physicians who collaborate with major institutions in clinical trials is an important component of the NCI program. The contributions of these participants is recognized by NCI, the clinical Cooperative Groups, and many Cancer Centers. To assure and maintain the high quality of clinical research conducted by the clinical trials organizations, it is important to maintain a strong relationship between these affiliate investigators and the research base.
To accomplish this objective, research base administrative policies and procedures are needed that permit all participating investigators to have easy access to accurate and timely information on matters of scientific importance and to conduct treatment research in compliance with Federal regulations. The following guidelines have been provided to assist research bases in formulating specific policies for strengthening the relationship between affiliate investigators consistent with these goals. The content of the following guidelines applies to affiliates of any research base.
We recommend that each research base develop a formal affiliate policy consistent with these guidelines.
13.1 Affiliate Investigators Definition
An affiliate investigator of a research base is a physician who:
- Participates in research clinical trials organized by the research base, and
- Has satisfied all criteria for affiliate membership as defined by the research base.
13.2 Requirements of an Affiliate Investigator
All affiliate investigators:
- Must have demonstrated competence in the treatment of cancer patients as defined by the research base
- Must have the ability to accrue a minimum number of patients as set by the research base
- Must have established a close cooperative professional relationship with the research base through regular participation in group meetings and/or educational sessions sponsored by the research base
- Must have successfully passed a probation period during which time the affiliate investigator has demonstrated:
- Ability to enter patients on protocol
- Ability to comply with the protocol
- Ability to provide accurate and sufficient data to the research base
- Ability to adhere to the procedures and standards of the research base and the CTEP
- Must have an appropriate OHRP assurance for the protection of human subjects (Section 12.1.2).
13.3 Responsibilities of Affiliate Investigators
The affiliate investigator must adhere to the procedures of the research base and CTEP for the conduct of clinical research by:
- Meeting the record keeping policies of the research base
- Making certain that each protocol has the full approval of an authorized IRB prior to involvement of human subjects
- Making certain that each patient signs and is given a copy of the IRB-approved consent form. The consent forms should be maintained on file by the affiliate investigator
- Complying with the policies of CTEP and FDA concerning the use of investigational agents, which include as a minimum:
- Filing a signed FDA Form 1572, http://ctep.cancer.gov/forms/index.html, with CTEP
- Observing DCTD policy and procedures for the proper and secure storage of investigational agents, including maintaining NCI Agent Accountability Records, http://ctep.cancer.gov/forms/index.html (Appendix XII).
- Agreeing that primary medical records of patients may be audited in accordance with the policies of the research base, CTEP, and FDA (Section 16).
13.4 Responsibilities of Research Bases for Affiliates
13.4.1 The Cooperative Groups
The Cooperative Groups have the following responsibilities for their affiliate investigators:
- Maintaining an accurate and up-to-date list of all member institutions and affiliate investigators
- Informing CTEP of important actions regarding membership status of its member institutions and affiliate investigators
- Reviewing performance of all members in periodic and timely fashion (including on-site data audits)
- Assuring that all members, full and affiliate, are in compliance with CTEP policies and DHHS regulations
- Ensuring that each affiliate institution/investigator has registered an appropriate assurance with the OHRP, http://ohrp.osophs.dhhs.gov/index.html.
- Ensuring that full local IRB approval has been obtained prior to allowing registration of patients on any protocol and on a continuing basis
13.4.2 The Principal Investigator Responsibilities for Affiliate Investigators in Cooperative Group Protocols
The principal investigator in Cooperative Groups has the following responsibilities for affiliate investigators:
- Assuring the Cooperative Group that the affiliate member's performance meets the procedures and standards of the research base
- Informing the Cooperative Group of important changes in affiliate member relationships
- Agreeing to site-visit the affiliate as deemed necessary by the Cooperative Group
- Providing the affiliate with accurate and timely information on matters of scientific importance
- Communicating to affiliates in a timely manner all policies (and any changes in policy) on the conduct of clinical research.
13.4.3 Cancer Centers
The Cancer Centers have the following responsibilities for their physician members and for their affiliate institutions:
- Maintaining an accurate and up-to-date list of all members and affiliates
- Informing CTEP of important actions taken regarding membership status of its members and affiliate investigators
- Conducting periodic and timely review of the performance of all members and affiliate investigators (including audits of affiliate data)
- Agreeing to site-visit the affiliate investigator in accord with CTEP policies
- Assuring that all members and affiliate investigators are in compliance with CTEP policies and FDA regulations
- Ensuring that each affiliate institution/investigator has registered an appropriate assurance with the OHRP, http://ohrp.osophs.dhhs.gov/index.html
- Ensuring that full local IRB approval has been obtained prior to allowing registration of patients on any protocol and on a continuing basis
- Communicating to affiliate investigators in a timely manner all policies and changes in policy on the conduct of clinical research.
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