Policy and Procedure: Adverse Event Reporting

Policy for CRC Only Studies

All CRC adverse events and/or protocol deviations will be reported to the CRC within 15 days of the event. One point that should be noted is that the threshold for adverse event reporting at the CRC is lower than that of the IRB. Adverse events are reported through several mechanisms. These include direct adverse events reporting to the Fletcher Allen Health Care (FAHC)/University of Vermont IRB as well as the internal FAHC reporting system including the Fletcher Allen Health Care Event Reporting Form (SAFE form) or other forms which outline the event and grade its severity.

The Compliance Specialist and/or Research Subject Advocate will review the reports and forward them to the CRC Program Director, Administrative Director and protocol Principal Investigator. The Compliance Specialist and/or Research Subject Advocate will make a recommendation to the Principal Investigator as to whether the event is likely to require immediate reporting to the IRB. All local deaths while on active treatment should be reported to the IRB within 24 hours. For the full IRB reporting requirements, see the above link. In addition, all adverse events will be reported to the IRB as part of the Annual Safety Report, regardless of severity.

Policy for Multicenter Studies at the CRC

For subjects enrolled locally in protocols conducted at the UVM CRC that are part of multicenter projects, the above policies still apply. We anticipate reporting of all adverse events including significant protocol deviations and/or other unanticipated problems. In addition, there are several other policies set forth by the RSA office.

For subjects enrolled at other sites for multi-center protocols that are active on the UVM CRC we do not require a filling of all adverse events. Due to the cumbersome nature of all adverse events including protocol deviations, and/or unanticipated problems that may exist and vary among centers in muticenter studies, the RSA office does not require a comprehensive listing of all AE’s that take place at other sites. However, principal investigators, or their designees, should file any serious and/or unexpected adverse events from protocol participating sites with the RSA office.

Procedure

Principal Investigators or Clinical Coordinators are required to forward copies of all serious adverse events as well as non-serious adverse event reports submitted to the IRB to the RSA Office in the CRC. Under the current guideline, the RSA must receive these reports within 15 days of an event.

And/Or

CRC staff are required to forward completed SAFE/ Medication/IV event forms to the CRC Nurse Manager and the RSA office. Under the current guideline, the RSA must receive these reports within 15 days of an event.

The RSA office will forward copies of the SAFE or Medication/IV Event form to:

• CRC Program Director
• CRC Administrative Director
• Protocol Principal Investigator

The RSA may provide recommendations to the Principal Investigator for reporting requirements of all adverse events that are submitted. These may include, but are not limited to, reporting to the UVM/FAHC IRB, Food and Drug Administration, Department of Health and Human Services, CRC Scientific Advisory Committee or other appropriate agencies. The RSA will confirm that additional reporting is completed.

The RSA will generate an annual Adverse Event Report to review and evaluate safety of research participants. This report will be distributed to the protocol Principal Investigator, UVM/FAHC IRB, and the Scientific Advisory Committee (SAC).

Contact:

Peter Cherouny , Research Subject Advocate
Office:    Baird 796, Tel. (802) 847-5111
email:    peter.cherouny@vtmednet.org

 

Last modified June 23 2011 11:27 AM