How frequently is the sponsor expected to submit safety information to the investigators in clinical trials?

29 Jan How frequently is the sponsor expected to submit safety information to the investigators in clinical trials?

According to the European Commission CT-3: “Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use”:

The sponsor must ensure that all SUSARs are reported to the authorities as soon as possible; within seven days for fatal and life-threatening SUSARs and within 15 days for other SUSARs.

The sponsor should also inform all investigators. The purpose of informing the investigators is to inform the investigators about safety issues in light of the reported SUSARs.

The information must be concise and practical and where possible should be aggregated in a line listing of SUSARs in periods as warranted by the nature of the protocol/project and the volume of SUSARs generated. This line listing should be accompanied by a concise summary of the evolving safety profile of the product.

However, the CT-3 guidance does not stipulate a maximum number of days/weeks/months within which the investigators are to be informed of specific safety information.

GCP 5.16.2 does not include specific timeline either but only that the sponsor should promptly notify all concerned investigators of findings that could adversely affect the safety of subjects or impact the conduct of the trial or alter the IRB/IEC’s approval/favourable opinion to continue the trial.

Only U.S. regulations (21 CFR 312.32(c)(1)) give a clear, 15-day timeline for reporting SUSARs to clinical trial investigators.

Therefore it is recommended that the sponsor has a procedure describing the reporting process of safety data to the investigators. It should include a clear instruction on which information should be sent to the investigators within which timeline, and which other information can wait and be sent out as regular line listings in periods.

National requirements must always be followed; e.g. for trials conducted under an IND in US, the US requirement as stated in 21 CFR 312.32 applies.

PharmaGCP’s Golden Rules contain clear instruction on how investigator and sponsor, respectively, should handle adverse events, for only 15 Euro. https://pharmagcp.com/golden-rules/