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All clinical research projects must adhere to the regulatory and reporting requirements of their sponsors and Institutional Review Boards (IRBs). All drug and device studies must also adhere to the requirements set forth by the US Food and Drug Administration (FDA).

Each of these entities has its own requirements, so be sure to understand each of them individually and plan accordingly. These requirements can be a lot to manage, so creating a shared calendar for your team can be very useful.

The Principal Investigator (PI) is responsible for all regulatory and reporting requirements but, with proper training and oversight, may delegate these responsibilities to members of his/her study team. These duties are documented in the Delegation of Responsibilities Log.

The Partners Human Research Committee (PHRC), the Partners IRB, requires all studies to report unanticipated problems and adverse events (AE) in a timely manner. Adverse Events are “any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease…whether or not associated with the subject’s participation in the research.”

Internal adverse events that are unexpected and related/possibly related to the research, and external adverse events that are serious, unexpected and related/possibly related must be reported to the IRB within 5 working days/7 calendar days of the date the investigator first became aware of them.

Adverse events that are expected (i.e. documented in the protocol) are not reported to the IRB.

For investigator-monitored studies, a cumulative report of all adverse events must be submitted at continuing review. The Adverse Events Tracking Log should be used to record these events.

The Partners Human Research Committee (the Partners Institutional Review Board) also requires all studies to submit all amendments (changes to the protocol) and deviations for review. A deviation is any alteration/modification to the PHRC-approved research without prospective PHRC approval.

A major deviation is any alteration/modification to the PHRC-approved research that has the potential to negatively impact subject safety or integrity of study data (ability to draw conclusions from the study data), or affect the subject’s willingness to participate in the study. A minor deviation is any deviation from the PHRC-approved research that does not have the potential to negatively impact subject safety or integrity of study data (ability to draw conclusions from the study data), or affect subject’s willingness to participate in the study.

Unapproved major deviations must be reported to the PHRC within five (5) working days of the date the investigator becomes aware of the unapproved deviation.

Unapproved minor deviations are to be recorded by the investigator in a protocol specific Minor Deviation Log and submitted to the PHRC at continuing review. For research limited to the use of medical records or excess human material, in lieu of a Minor Deviation Log, unapproved minor deviations may be described in the Protocol Deviations section of the continuing review form.

The PHRC requires all studies to submit a Continuing Review on a regular basis as determined by the IRB. The IRB will send a Continuing Review notice 90, 60 and 30 days prior to its due date, however it is the responsibility of the study team to manage the Continuing Review submission process. Be prepared to provide your study’s enrollment data, unanticipated problems and safety data to complete this report.

The US Food and Drug Administration (FDA) requires reporting of protocol amendments and adverse events and has annual reporting requirements for all holders of INDs and IDEs that are separate from the Continuing Review requirements of the IRB. These reports must be submitted to the FDA annually +/- 2 months.

Non-federal sponsors will also have their own reporting requirements. Be sure to gain a firm understanding of what is required of you by when as soon as you are notified of funding. This will help significantly in your planning process.

Studies that are registered with ClinicalTrials.gov require updates every six months.

Finally, if your study has a Data Safety and Monitoring Board (DSMB) you may also have to report to them regularly. Be sure to check your DSMB’s charter to ensure adherence to their designated plan.

Learn More

The Division of Clinical Research (DCR) at Mass General helps to connect investigators and study staff members to a variety of courses, services and resources that provide assistance with every step of the clinical research process. These include offerings from the DCR itself, as well as associated research institutions and organizations. Mass General resources are listed first; DCR programs are noted in parentheses.

Courses

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Additional Support

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