Services - ICH-GCP Training

Training Objectives:

• To develop skills in co-ordinating clinical research studies to ICH GCP
• To understand collection of essential documents and maintenance of the TMF
• To review the protocol and its implications on practice and budgeting
• To inspire confidence in communicating with Ethics Committees
• To prepare for sponsor audit and regulatory inspections
• To understand the elements of adverse event reporting
• To understand Source Data Verification in relation to CRF completion
• To understand the purpose of a site initiation in relation to study needs
• To meet and network with others working in a similar environment

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