ON-DEMAND - Study Essential Documents and the Regulatory Binder (SUMMER 2023)

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

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Certificate Program CORE

Competency: CT Operations

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ENROLLMENT/ATTENDANCE DETAILS

As of Nov 2018, this course is now an ON-DEMAND/ self-paced.

Enrollment will open on Jul. 1, 2023 

There are four components to receive completion.

1) Launch the course

2) Enter three takeaways

3) Complete the quiz by Sept 30, 2023

4) Complete the Evaluation by Sept 30, 2023