Adverse Events and IND Safety Reports
Documenting and Reporting Adverse Events
- Protocol Directors or their designee must document all adverse events (AEs) in the participant’s study records in a narrative summary or on a case report form.
- Reporting to Industry / Cooperative Group / NCI Sponsor:
- In general, report Serious Adverse Events (SAEs) to the study sponsor within 24 hours. Refer to the protocol document for sponsor specific reporting procedures.
- Discuss specific questions with the protocol’s Medical Monitor, CRO, or other sponsor contact.
- Reporting to the Stanford Cancer Center DSMC (all trials):
- Report SAEs Grade 3 and above to the CCTO Regulatory Manager using the Adverse Event Communication Form. A description of the SAE must be attached.
- Reporting to the Stanford IRB (all trials):
Report unexpected problems (UPs) to the CCTO Regulatory Manager using the Adverse Event Communication Form. The CCTO Regulatory Manager will confirm that the report must be submitted to the IRB. Study staff will report to the IRB using eProtocol. - Reporting to the FDA (Sponsor-Investigator Trials only):
Report SAEs that are unexpected and at least possibly related to the investigational agent or device to the CCTO Regulatory Manager using the Adverse Event Communication Form. Attach a completed FDA Form 3500A. The CCTO Regulatory Manager will submit the report to the FDA, or will assist the study staff to complete the submission.
AE Resources
- Adverse Event Communication Form Oct 2007
- Adverse Event SOP Sep 1, 2009
- FDA Form 3500A
Managing and Reporting IND Safety Reports
IND Safety reports notify investigators of adverse events at other study sites. Under 21CFR 312.32 sponsors are required to notify all participating investigators of any adverse event that is at least possibly related to the investigational agent that is serious and unexpected.
Reporting IND Safety Reports (Outside Safety Reports):
- Reporting to the Stanford Cancer Center DSMC (all trials)
- Sponsors or the sponsors’ designee should send a copy of IND Safety Reports to the CCTO Regulatory Associate at CCTO-Safety@stanford.edu, or MC 5548.
- Original documents should be received by the site study coordinator and kept in the site regulatory binder.
- Reporting to the Stanford IRB
- The study Protocol Director or his/her designee should review each IND safety report to determine if it meets the IRB definition of a unexpected problem (UP). See: Events and Information that Require Prompt Reporting to the IRB.
- Report UPs to the CCTO Regulatory Manager using the Adverse Event Communication Form. The CCTO Regulatory Manager will confirm that the report must be submitted to the IRB. Study staff will report to the IRB using eProtocol.
Trial Administration