Clinical Research Operations

Multi-Institutional Adverse Events Reporting and Management

Purpose: Steps to be completed when adverse events occur at participating sites including expedited adverse events in a multi-institutional study in which the CCR coordinates/sponsors.

STEP 1: Adverse Event Documenting

1. All adverse events must be documented in source documentation.

STEP 2: Adverse Event Recording

1. All adverse events must be entered into C3D.
   • Note: Exceptions will be those adverse events listed in the protocol as not required to be captured.

STEP 3: Adverse Event Reporting

A. Adverse Event Reporting to NCI IRB

1. Sites should be aware of the expedited NCI IRB reporting requirements listed below. All NCI protocols must include an Adverse Event Reporting section. For expedited reporting of adverse events and deaths, the CCR protocol PI will report to the NCI-IRB:
   • All serious adverse events (SAEs) that are notin the consent form, but are possibly, probably or definitely related to the research. An SAE is defined as an untoward medical occurrence that:
     • resulted in a death;
     • was life-threatening;
     • required or prolonged hospitalization;
     • caused persistent or significant disability/incapacity;
     • resulted in congenital anomalies or birth defects; or
     • required intervention to prevent permanent impairment or death.
   • All other deaths not included in the SAE category above.
   • All deaths that occur within 30 days of the last dose of study drug or treatment.
   • All grade 3 and 4 (CTCAE) events that are not in the consent and that are possibly, probably or definitely related to the research, but not included in the SAE category above.
   • Reports must be received by the NCI-IRB within 7 days of notification of the event.
2. External participating sites should complete the CCR Expedited Adverse Event form provided and send to the Study Coordinator either by email or fax.
   • Note: All adverse events entered on the NCI IRB Expedited AE form should be entered in C3D.
3. The CCR Study Coordinator should submit the external site’s copy of the SAE in the CCR Integrated Medical Research Informational System (iRIS) to the NCI CCR IRB.

B. For CTEP-Sponsored Studies (via AdEERS)

1. See protocol for expedited AE reporting requirements to CTEP.
2. All expedited adverse event reporting to CTEP must be done via AdEERS: https://webapps.ctep.nci.nih.gov/openapps/plsql/gadeers_main$.startup
3. The participating sites should copy the CCR Study Coordinator (entering the email address) and the CCR Principal Investigator on all AdEERS reports.
4. All adverse events entered in to AdEERS must also be entered in to C3D by the time of the next data submission to CTEP.

C. For Other Non-CTEP-Sponsored Studies

1. Follow protocol instructions on reporting adverse events.

D. Participant Site Reporting

1. Follow local IRB policy to report Expedited AEs.

STEP 4: File Expedited Adverse Event Documentation

1. The Coordinating Center should file copy of Expedited AE in their master regulatory binder and in their regulatory binder for that site:
   • Include all related correspondence
   • Include documentation of submission to NCI CCR IRB, and confirmation of receipt
   • Include documentation of submission to local IRB, if applicable.