Webinar: Research Document Management
January 26, 1:00 pm to 3:00 pm
One event on January 26, 2021 at 1:00 pm
One event on April 28, 2021 at 1:00 pm
In this workshop offered by Penn State’s Institutional Review Board (IRB), participants will review the good clinical practice (GCP) definitions and regulations for research data management and define source documentation and list examples. Presenters will discuss the type of essential documents as described in ICH GCP 8. The presenters will list how essential documents are maintained by the site and/or sponsor throughout the course of the trial and will outline the guidelines for data quality (ALCOA) and discuss source document creation, case report forms, electronic data entry, research charts and EMR as source documentation.
Additionally, those attending will be able to prepare and organize regulatory file materials, subject files and identify deviations to appropriate management of data and files.
Registration is required, and the Zoom link will be provided after registration.