
ON-DEMAND- Study Essential Document and the Regulatory Binder (Winter 2021)
Started Dec 10, 2020
Full course description
Course open to all faculty, fellows/residents, staff working on clinical research projects at Stanford.
By attending this workshop, 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, Quality and Compliance Manager, Stanford Center for Clinical Research
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Certificate Program CORE
Competency: CT Operations
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ENROLLMENT/ATTENDANCE DETAILS
As of Nov 2018, this seminar is now an ON-DEMAND/ self-paced course.
There are three components to receive completion.
1) Launch the course
2) Complete the quiz by Mar. 31, 2021
3) Complete the Evaluation by Mar. 31, 2021