Who Receives the Report

Part of Pharmacovigilance and Drug Safety (PV) Training: The Reporting Clock.

About 1 minutes. Free, in your language, no account needed.

More than one audience

An expedited report from a clinical trial does not go to one place.

Regulatory authorities in the territories where the trial is running, through the electronic gateways they specify.

Ethics committees or IRBs, according to local requirements, which vary considerably.

Investigators at all participating sites, because a clinician treating participants needs to know what has been seen elsewhere in the study. This is the obligation most often handled poorly, because it is the one with the least automated infrastructure behind it.

Partners, where a safety data exchange agreement exists with a licensee, distributor or co-development partner. The agreement sets the timelines and they are usually shorter than the regulatory ones, precisely so that the partner can meet their own.

Format

Individual case reports are submitted electronically in the ICH E2B format through the relevant gateway. The specifics of which gateway, which profile version and which acknowledgment to expect are operational details that differ by region and change over time.

Acknowledgments are part of the submission

A transmission that failed is not a submission. The acknowledgment confirming receipt is what closes the obligation, and a failed or negative acknowledgment means the report is still outstanding with the clock still running.

Checking acknowledgments is dull and it is the point at which apparently compliant organizations discover months of reports that never arrived.

Keep the distribution list current

Sites open and close. A distribution list built at study start and never revised will send reports to closed sites and miss new ones.