Module 5 Presentations

Quality Systems

• Key processes not documented or reflective of current practice/legislation or what’s actually happening. • Uncontrolled documents used for key processes such as adverse event collection. • Failure to implement in-process checking procedures (quality control). • Key staff with no training or no evidence of training in relevant GCP aspects, including the UK legislation.

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Investigational Medicinal Product (IMP)

• No/incomplete records to confirm who got what, when. • Emergency unblinding access not available or tested by the PI prior to participants being supplied with the trial medication. • Accountability records do not reflect how the IMP was provided and used, therefore can’t reconstruct how it was managed during the trial adequately. • IMP held outside pharmacy not stored adequately (i.e. inadequate temperature monitoring, unsecure/inappropriate access, inadequately identified as trial medication etc.).

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