ON-DEMAND - Study Essential Documents and the Regulatory Binder (SPRING 2023)
Full course description
Course open to all faculty, fellows/residents, staff working on clinical research projects at Stanford.
By completing this course, you will:
- Understand what essential documents are and the laws and guidelines that govern their content
- Differentiate between the different types of essential documents and recognize the different common definitions.
- Be able to follow best practices for creating and maintaining your study's essential documents.
- Identify the elements monitors and auditors look for when reviewing your study's essential documents.).
Speaker: Maya Berdichesky, DMD, Trial Innovation Network CTSA Hub Liaison Manager, Spectrum
Certificate Program CORE
Competency: CT Operations
As of Nov 2018, this course is now an ON-DEMAND/ self-paced course.
Enrollment will open on Apr. 1, 2023
There are four components to receive completion.
1) Launch the course
2) Enter three takeaways
3) Complete the quiz by Jun 30, 2023
4) Complete the Evaluation by Jun 30, 2023