The Clock and What Starts It

Part of Sub-Investigator (SUBI) Training: Adverse Events and Attribution.

About 2 minutes. Free, in your language, no account needed.

Awareness starts it, not paperwork

For a serious adverse event, the reporting timeline begins when the site becomes aware, typically within 24 hours to the sponsor.

Awareness includes a phone call from a participant, a letter from another hospital, or a colleague mentioning an admission.

A weekend does not pause it

The clock runs in calendar time. Sites need a route that works on a Friday evening, and knowing that route is part of your role.

Report on incomplete information

Waiting for the discharge summary before making an initial report is the most common way a timeline is missed.

Report what you know, mark it as initial, and follow up. An incomplete report inside the window is correct; a complete one outside it is not.

What the initial report needs

An identifiable participant, an identifiable reporter, a suspect intervention, and an event. That is the threshold.

Everything else follows.

Follow-up is part of the obligation

Outcome, resolution date, treatment given, and the final causality assessment. A serious event reported and never followed up is an open item in the safety database.

Events found in records after the fact

A hospitalization discovered weeks later when notes arrive is reported when you become aware of it, with the actual event date and the awareness date both recorded.

Do not backdate the awareness to look compliant. The gap is explainable; a false date is not.

Pregnancy and other special situations

Most protocols require reporting a pregnancy in a participant or a partner on their own timeline, whether or not it is an adverse event. Overdose, medication error and lack of effect often have specific rules too.

Know which special reporting your protocol requires before one arrives.