As a clinical researcher, you should always be ready for an audit. This TRIUM training will uncover the secret to become ‘audit proof’ at any time.
The only evidence for regulatory compliance whiles ensuring subject safety and well-being and quality data are the essential – and source documents related to the clinical trial. After an introduction on audits, expectations and behaviors, a practical session using a real TMF will follow. The trainer, who is also an auditor in real life, will review the TMF together with the participants whiles acting and asking questions as if she was auditing. Participants will learn hands-on how the documents need to be aligned and ‘tell the story’ of the trial to any stakeholder.
At the end, you will receive a certificate and handy hand-outs for use in the field.
Note: Upfront approval from the sponsor for the use of the TMF will be assured. A CDA will be required to sign for any participants not working on the trial for which the TMF is used.
By the end of this TRIUM Training you should be able to:
- Define audits and explain the difference with inspections
- List the organizational and behavioral expectations to ensure a successful audit
- Critically assess your TMF for being ‘audit proof’
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.