Course Description

Good Documentation Practices for Clinical Study Files

Course Description:

This course examines the Good Documentation Practice (GDP) requirements for clinical investigations and offers recommendations to effectively create and maintain clinical study files.

As numerous critical records, data, and information are collected during clinical studies, proper documentation is crucial to guaranteeing quality and compliance with GDPs.

The content of this course is based on:

  • 21 CFR 820.180
  • 21 CFR 812.140
  • ISO 14155
  • ISO 13485

Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Ensure the traceability of all data and documents in regard to regulatory requirements and quality assurance standards
  • Set up, manage, and maintain clinical study files in compliance with GDPs

Who Should Enroll:

Monitors, study coordinators, clinical research assistants, data management assistants, data and project managers, biostatisticians, and quality assurance and regulatory personnel who handle clinical investigation data and documents are all welcome to participate in this course.

Prerequisite Knowledge/Requirements:

The following courses are required:

  • Introduction to Good Clinical Practice (ID 42)
  • ISO 14155: 2020 - A Summary Review (ID 144)
  • ISO 14155:2020 – GCP Certificate

Subject Matter Expert:
Danielle Giroud

45 min

Related resources:

Case studies:

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Premium Account: € 121.00

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