Summit: Study Documents

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

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About this Course

This course examines the role that essential documents play in a study’s adherence to Good Clinical Practice (GCP) guidelines. It outlines best practices for source documents and weighs the benefits and disadvantages of E-Source and web-based platforms. The course describes the requirements for electronic records and signatures, as well as the obligations for document storage and archiving. It concludes by detailing Good Documentation Practices and proper procedures for data entry.

Language Availability: English

Suggested Audiences: Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Faculty, Principal Investigators (PIs), Quality Control/Quality Management Professionals, Regulatory Affairs Professionals, Research Administrators, Sponsors, Study Sites

Organizational Subscription Price: Included with the Summit: Document Control and Study Documents series, available for $675 per year/per site as a subscription add-on for government and non-profit organizations; $750 per year/per site as a subscription add-on for for-profit organizations
Independent Learner Price: $99.39 per person

Demo Instructions


Course Content

Summit: Study Documents

Learning Objectives:

  • Examine essential study documents.
  • Identify requirements for medical records and source documents, electronic records and signatures, record retention, and data entry.
  • Describe good documentation practices.

Recommended Use: Required
ID (Language): 21541 (English)


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