A Manual for Participants in Clinical Trials of Investigational Agents ...

3.2.3 Establishment of an Affiliate Program
An affiliate investigator is a physician who participates in a clinical trial organized by a
major institution and has satisfied all criteria for affiliate membership as defined by the
primary institution (see Section 13). Engaging affiliate investigators often contributes to
cancer clinical trial success. The clinical trial site must be as concerned about the quality
of research performed by its affiliate investigators as it is with that of its own staff. The
Principal Investigator must oversee affiliate investigators closely.
CTEP has established a set of guidelines to assist clinical trial sites in developing a
policy toward affiliate investigators (see Section 13). Each clinical trial site participating
in study agent trials supported by CTEP and/or sponsored by DCTD may develop its
own affiliate policy in accord with these guidelines, provided they meet all CTEP
Guidelines.
The most important components of these guidelines are that the clinical trial site should,
(a) define qualifications necessary for affiliate investigators and (b) periodically review
their performance. Such review of performance should include site visits by investigators
from the clinical trial site.
3.2.4 Agent Accountability and Storage
Although FDA regulation holds the investigator accountable for the proper use of
investigational agents and ongoing reporting of study agents with the investigator,
designated staff may assume these responsibilities for investigators. Regardless, a
study’s principal investigator is ultimately responsible for compliance with Federal
requirements (see Section 15).
3.2.5 Reporting of Results to CTEP
Investigators on CTEP-supported studies (or organizations that assume responsibility for
investigators) must provide the following to CTEP:
• adverse events
• protocol amendments
• regular and final study results
• publications
• protocol status changes
The summaries and status of all CTEP studies must be reported via the reporting
mechanism best suited for the study. Section 10 provides additional detail on reporting
guidelines. The Cooperative Groups and Consortia inform CTEP of this information
directly. In all cases, the protocol chair is responsible for reporting to CTEP.
3.2.6 Data Management and Statistics
Since most cancer clinical trials involve professional staff other than the protocol chair,
the institution must integrate proper collection of clinical data into their medical practices.
Data collection is best done as data are generated; this practice promotes protocol
compliance and permits the protocol chair to monitor the study's progress. For these
reasons, data management organized and supported at the department or institution
level is usually more efficient and reliable than that which is left to the individual
investigator. CTEP does not require centralized data management by institutions
performing CTEP-supported trials, but is highly recommended. In the experience of
Section 3 - Investigator’s Manual 2009 8