Suggest a correction

Notifications of unexpected serious adverse drug reactions

Health Products (Clinical Trials) Regulations 2016

Match the official source exactly.

What needs fixing?

Wrong or mistyped textWrong structure or numberingWrong title or detailsDuplicated content

Proposed text

—(1) Where any USADR occurs in a subject during a clinical trial which results in death or is life‑threatening, the sponsor must ensure that —(a)all relevant information about the USADR is —(i)recorded; and(ii)reported to the Authority as soon as possible and in any event not later than 7 days after the sponsor first becomes aware of the event; and(b)any additional relevant information about the USADR is —(i)recorded; and(ii)sent to the Authority within 8 days of making the record referred to in sub‑paragraph (i).(2) Where any USADR occurs in a subject during the clinical trial, other than a USADR referred to in paragraph (1), the sponsor must ensure that all relevant information about the reaction is —(a)recorded; and(b)reported to the Authority as soon as possible and in any event not later than 15 days after the sponsor first becomes aware of the event.(3) Upon a request made by the Authority, the sponsor must furnish to the Authority a report of —(a)the sponsor’s assessment of the risks associated with a USADR; and(b)the steps proposed to be taken —(i)to mitigate the risk; and(ii)to inform the person whose consent is required for a person to be a subject or to continue to be a subject in the clinical trial, of the risk.(4) The sponsor must furnish the report referred to in paragraph (3) as soon as possible and in any event no later than 14 days after the Authority’s request.

What's the problem? (required)

Source link (optional)

Describe the problem (and edit the text or pick an issue type) to submit.

Suggestions are submitted anonymously. No account or personal information is required or sent.