Module 5 Presentations

Participant Confidentiality

• Participant details (name, date of birth, hospital number, address) sent outside the investigator institution without specific consent of the participant (i.e. in the informed consent). • Consent process was not consistent with that approved by the REC. • Wrong or unapproved informed consent form used. • Participants not re-consented in a timely manner. • Consent taken by staff not delegated or trained. Informed Consent

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Pharmacovigilance

• Serious Adverse Events (SAEs) not identified or recorded or reported within stipulated timeframes.

• Approved Reference Safety Information (RSI) not used when making expectedness assessments.

• SUSARs not reported within regulatory timeframes to MHRA and REC.

• Failure to monitor pregnancy to outcome.

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