CHÉOS Lunch and Learn: Good Documentation Practices and the value of learning from quality reviews
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April 7 @ 12:00 pm - 1:00 pm
Jasmine Grant, MEd., CCRP
Lead, Research Training Program
Cancer Clinical Research Unit
Princess Margaret Cancer Centre
The necessity of Good Documentation Practices in clinical research and the value of learning from quality reviews
Documentation is at the centre of clinical research activities and workflows for investigator sites, which is necessary for analysis of study results and meeting regulatory requirements. Proper documentation of source data is essential for the reconstruction and validation of the activities carried out by the clinical research teams. Adequate and complete documentation of protocol-related tests and procedures is important for the safety of research participants, and serves to substantiate the integrity of study data to sponsors and other stakeholders. The source data are entered into the Sponsor database according to the protocol, sponsor requirements, and Good Data Management practices.
In this session, we will:
- Review clinical research source data and documents
- Review Good Documentation Practices
- Review Good Data Management Practices in the electronic database/e-CRFs
- Review common audit findings experienced at academic sites