Module 5 Presentations

05/07/2024

The investigator shall:

Report to the Sponsor all SAEs unless the protocol provides differently within 24 hours of knowledge (CT-3, Section 4.3, paragraph 29)

Report to the Sponsor SAEs occurring to a

Record all AEs (including laboratory abnormalities) unless the protocol provides differently

Not actively monitor subjects for AEs once the trial has ended, unless provided otherwise in the protocol.

subject after the treatment of that subject has ended if he/she becomes aware of them.

The Organisation for Professionals in Regulatory Affairs

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Sponsor’s responsibilities

The Sponsor shall keep records of all AEs reported by the investigator.

The Sponsor must report all suspected unexpected serious adverse reactions (SUSARs) to the MHRA and to the Ethics Committees (ECs). Unblinded reports.

The Sponsor should send only blinded line listings to the investigators.

The Organisation for Professionals in Regulatory Affairs

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