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Essential Elements
1. Monitoring the progress of trials and the safety of participants
2. Plans for assuring compliance with requirements regarding the reporting of adverse events (AEs)
3. Plans for assuring that any action resulting in a temporary or permanent suspension of an NCI-funded clinical trial is reported to the NCI grant program director responsible for the grant
4. Plans for assuring data accuracy and protocol compliance
1. Monitoring the progress of trials and the safety of
participants.Description of these monitoring processes should include a
number of elements. Who actually monitors the trials? How often are the data
examined in the course of trial conduct? What do the monitors look for? What
procedures are in place to insure adequate feedback of information to
researchers and medical decision-makers, so that trials involving excessive
risk in relation to anticipated benefits are terminated appropriately? What is
the oversight or supervisory role of institutional committees, if appropriate?
What procedures does the institution have for coordinating multi-center
trials, if applicable?
In relation to who actually has responsibility for monitoring a trial, DSM
plans should explain how the institution averts or manages any conflict of
interest implicit in having a principal investigator (or a direct report of
the PI) as the only monitor of trials that pose significant risk to study
subjects.
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2. Plans for assuring compliance with requirements
regarding the reporting of adverse events (AEs). The plan should describe
the processes and oversight that the institution has in place for assuring
that AE reporting requirements are actually met. For multi-center trials
coordinated by the institution, the plan should outline procedures by which
the institution establishes a central reporting entity that collects and
reports AEs to all necessary destinations, including co-investigators at
participating institutions.
The requirements for proper reporting of AEs on clinical trials are complex
(summarized in the Appendix). Possible destinations for AE reports include the
institutional IRB, the sponsor (if an IND is involved), the FDA (for AEs from
commercially available agents), and, if gene transfer is involved, the NIH
Office of Biotechnology Activities (OBA). Note that current federal
regulations almost always require reporting of AEs in all categories of
clinical trials to the institutional IRB, in addition to what is specified in
the Appendix.
Note also that there is no requirement that individual AEs be reported
in real time to the NCI, unless NCI is also the IND sponsor of the study (see
the Appendix). Where appropriate, investigators should summarize toxicities or
adverse consequences of interventions as part of the progress reports in their
non-competitive (Type 5) or competitive (Type 2) renewal applications.
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3. Plans for assuring that any action resulting in a
temporary or permanent suspension of an NCI-funded clinical trial is reported
to the NCI grant program director responsible for the grant.These actions
include, for example, any FDA actions that affect NCI-funded trials (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-053.html).
It also includes actions by an IRB or by a commercial sponsor, or by the
investigator him/herself, if an NCI-funded trial is involved.
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4. Plans for assuring data accuracy and protocol
compliance. Institutions should describe what quality-control procedures
are in place for assuring data accuracy and completeness in studies funded by
NCI.
If an IND is in place, quality-control procedures are generally stipulated by
the IND sponsor and may be simply referenced or summarized in the DSM plan.
For studies not done under an IND, the institution should describe whatever
procedures are in place to assure data integrity and protocol adherence.
Appropriate procedures may range, for example, from regular data verification
and protocol compliance checks performed by a data manager and a principal
investigator, to a formal external data-audit process by an agent external to
the institution.
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