Reporting Requirements

Each sponsor has unique reporting requirements for events that occur during the clinical trial and need to be reported to the sponsor by individual site PIs. These reports are in addition to those that a study team must make to the IRB. The PI is ultimately responsible for ensuring that the sponsor’s reporting requirements are followed; however, the study team must be knowledgeable of the sponsor’s reporting requirements to ensure compliance. The sponsor’s reporting requirements are located in the protocol, clinical trial agreement, or other sponsor correspondence.

The sponsor will define which events need to be reported to the sponsor and at what frequency. The sponsor should also provide instructions for reporting (e.g., electronic entry on a sponsor’s website or via electronic data capture system). The sponsor’s time frame for reporting should be taken seriously and reported to the IRB as noncompliance if it is not followed.

Adverse Events

Adverse events (AEs) must be recorded locally and then considered for sponsor and/or IRB reporting. All AEs don’t need to be reported to sponsors and IRBs; thus, the number of AEs recorded locally will be greater than the number of AEs reported. Sponsors may require reporting of AEs of specific grade or severity and/or interest to the sponsor or FDA (usually called adverse events of special interest (AESI). AESIs will be defined in the protocol and are events that the sponsor or FDA are monitoring for importance. CTAC recommends transcribing all adverse events to an AE log with each entry graded, attributed, signed, and dated by the PI or medically qualified designee. The AE log could include a column listing the date the event was reported to the sponsor and/or IRB.  

Protocol Deviations and/or Noncompliance

CTAC recommends transcribing all protocol deviations to a log with each entry signed and dated by the PI or designee. The log could include a column listing the date the event was reported to the sponsor and/or IRB. Report deviations to the sponsor within the sponsor’s required time frame. Periodically review the log for patterns of similar deviations that could represent a problem.

Monitoring Reports

The sponsor may require study teams to report adverse events or deviations found on routine monitoring visits that do not meet the IRB’s reporting requirements. It is important for the study team to be knowledgeable of the sponsor’s reporting requirements included in the protocol, clinical trial agreement, or other sponsor’s correspondence. The more stringent reporting requirement should be followed.