Full course description
Live Session: Thursday, September 9, 2021 @10:00am - 11:00am, Zoom
REd Synchronous classes are taught by subject matter experts, and provide both fundamental and advanced skills training in flipped classroom format. These classes are offered live (currently, via Zoom), wherein participants will attend and participate in the 1-hour live lecture/presentation. Participants will be required to work pre-class and post-class activities outside the classroom. These activities can include: readings, videos, etc.
Class Description: This class covers the basic requirements for source documentation and record retention in human subject research. Industry standards, GCP, FDA, and local IRB requirements will be reviewed. Strategies for implementing the principles of ALCOA-C in source documentation, suggestions for corrective action plans, and the appropriate use of a note to file vs. a deviation report will be presented.
Class Objectives: At the conclusion of this class, you should be able to:
- Identify regulations, guidelines, standards, and best practices
- Determine how to properly document data and discuss helpful tips
- Briefly outline retention of records
Class Duration: Total duration for synchronous classes are approximately 2 hours. Those two (2) hours will be broken down into:
- A live session which will take approximately 1 hour (45-minute presentation and 15-minute Q&A) and;
- Pre and Post-work activities which will take approximately 1 hour, in total.