Documentation and (e)CRF Best Practices

Description
Operational

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.

Learning objectives

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
Training design
Classroom Training
Training duration
4 hour
Training Language
English
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Isabelle De Bock
Isabelle De Bock has almost 17 years of clinical research experience in the medical device industry. While she started as an international CRA, Isabelle held many other roles and responsibilities within the clinical landscape varying from project lead and clinical manager to compliance manager responsible for SOP maintenance, training, audit support & inspection readiness. Prior to joining TRIUM in September 2019 as Manager Operations, Isabelle was a dedicated supervisor for about 5 years, managing an international group of monitors and building up from scratch an in-house CRA team, having line management responsibilities for more than 15 employees at once.  Isabelle is used to work in a global environment across different departments & multiple regions around the globe. She holds a master degree in Biology, did 2 years of PhD scholarship at the University of Leuven and obtained a Teacher Degree as well prior to joining the clinical research world.