In clinical research, we have a saying: ‘When it is not documented, it did not happen’. But how can we make sure we documented everything and done it as per applicable regulatory body expectations? Not an easy task, and we are here to help!
This TRIUM Training explains in detail good documentation practices and how to prepare, manage and store the trial related Trial Master File (TMF) from both a site and a sponsor perspective. Topics include Source Documentation development, use and monitoring, (electronic) Case Report Form ((e)CRF) development and review, Source Data Verification (SDV) and Source Data Review (SDR).
Case studies, opportunities for discussion and exercises are part of the design to ensure proper understanding of each key stakeholder’s part in the process, tips and tricks development, knowledge and skills retention and fast transformation of the content into practical application.
At the end, you will receive a certificate for attendance and handy hand-outs for use in the field.
By the end of this TRIUM Training you should be able to:
- List the global legislation and guidelines regulating the document management and data handling procedures
- Prepare, manage and store the TMF for your clinical trial(s)
- Develop and/or review source documents and CRFs according applicable legislation expectations
- Conduct SDR and SDV activities that ensure compliance confirmation or early issue detection
- Share tips and tricks on quality document management
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.