The MHRA GCP Inspectorate has updated their definition of critical to include, ‘where provision of the Trial Master File (TMF) does not comply with Regulation 31A 1-3, as the TMF is not readily available or accessible, or the TMF is incomplete to such an extent that it cannot form the basis of inspection and therefore impedes or obstructs inspectors carrying out their duties in verifying compliance with the regulations.’
This follows numerous issues with inspector access to TMFs and incomplete TMFs. The TMF provides the basis for inspection by the competent authority (2005/28/EC). The UK Clinical Trial Regulations (2004/1031, Regulation 31A) require that the sponsor must keep a TMF and it must be readily available and shall at all times contain the essential documents relating to the trial.
This course demonstrates how to set up, maintain and manage a document system that meets the required regulatory standards. It gives an overview of the specific requirements in document management and explains the need for an audit trail of documents that is transparent and robust. Delegates are guided through the process of archiving documentation and the preparation for, and participating successfully in, a quality assurance audit or regulatory inspection.
• Summarise the regulatory framework of Good Clinical Practice and the relevant European Directives
• Review the GCP requirements for essential documents
• Describe the significance of document management in clinical research
• Develop a systematic approach for preparing documents for archive
• Identify the requirements for participating successfully in a quality assurance audit or regulatory authority inspection
• Review of the regulatory framework of Good Clinical Practice
• EU Clinical Trials Directive
• GCP requirements for essential documents
• Electronic Records Management
• Audits & inspections
• Investigator archiving
• GCP & RA compliant archiving and retention
• Preparation & tracking of documents for archiving
• Requirements for long term storage of archived documents
• What the inspectors are waiting to see
• How to select a suitable of site company
• Alternative long-term storage media