Reporting Requirements


Each sponsor has unique reporting requirements for events that occur during the clinical trial and that 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 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 will generally be located in the protocol, clinical trial agreement, or other sponsor correspondence.

Defining Reporting Events and Time Frame 

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

Adverse Events

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.  Paper copies of reports made to the sponsor should be kept with the research records.

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.

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.  Generally speaking, the most stringent documented requirement (that err on the side of more reporting) should be followed.   If the monitor asks the PI to report something to the IRB that does not fall within the documented sponsor reporting requirements, talk to the monitor about the Emory and Western IRB reporting requirements.  If the monitor or sponsor is persistent about reporting to the IRB, then the study team must submit the report to the IRB.