Why Should You Attend:
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).This webinar will help you understand in detail the new requirements for trial master files (TMF).
Areas Covered in the Webinar
- Trial Master File (TMF) background and rationale
- The essential documents to include in a TMF
- Organizing and maintaining a TMF
- Standard Operating Procedure required to support TMF
- Inspection of TMF records
Agenda
- Trial Master File (TMF) background and rationale
- The essential documents to include in a TMF
- Organizing and maintaining a TMF
- Standard Operating Procedure required to support TMF
- Inspection of TMF records
Who Should Attend
- Lead CRAs
- CRA Managers
- Project and/or Study Managers
- Project and/or Clinical Trial Assistants
- Clinical Operations Administrators
- Quality Assurance Personnel
- Auditors
- Sponsor and CRO personnel involved in set up, maintenance, and auditing of the Trial Master File for sponsors
- Consultants working in the life science, tobacco and related industries who are involved in computer system implementation, validation and compliance
