Summit: Document Control and Study Documents

This series provides instruction for documentation best practices.


About these Courses

This series examines the details of Good Documentation Practices (GDP). The two courses describe the requirements for writing controlled documents and discuss practical ways of maintaining proper systems for managing study documents. The series outlines the role that essential documents play in Good Clinical Practice (GCP). It also details rigorous procedures for creating study documents and entering study data in Electronic Data Capture (EDC) systems.

Language Availability: English

Suggested Audiences: Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Faculty, Principal Investigators, Regulatory Affairs Professionals, Research Administrators, Students, Study Sites


Basic Courses

Summit: Study Documents
New

Provides learners with best practices for creating and maintaining study documents.

study docs course card


FAQs

What courses are included in the Summit: Document Control and Study Document Series?

Summit: Document Control (coming soon) and Summit: Study Documents.

Who should take the Summit: Document Control and Study Document series?

The series is specifically intended for those who are responsible for conducting clinical research. Intended audiences include CRAs, CRCs, CROs, Faculty, Principal Investigators, Regulatory Associates, Research Administrators, Students, and Study Sites.

How long will the courses take a learner to complete?

Each course can be completed in 30-40 minutes.

Are the courses in the series eligible for continuing medical education credits?

These courses do not currently have CE/CME credits available.