Good Documentation Practices for Clinical Study Files
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
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
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.
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