Students' guide to documentation in clinical trials.

Area of Science:

• Clinical Research
• Medical Education
• Regulatory Science

Background:

• The COVID-19 pandemic disrupted traditional in-person training for students in human medicine and related fields.
• Adherence to Good Clinical Practice (GCP) principles for documentation in clinical trials is mandatory for all involved professionals, including students.
• Social distancing measures during the pandemic highlighted the urgent need for alternative training methods and self-study resources for students in clinical research.

Purpose of the Study:

• To address the challenges in training students for clinical trial documentation during the COVID-19 pandemic.
• To establish a unified quality standard for student training in clinical trial documentation.
• To develop a comprehensive resource for students and professionals involved in clinical trials.

Main Methods:

• An interdisciplinary, multiprofessional, and binational expert panel (Germany and The Netherlands) was convened.
• The panel developed the "Students' guide to documentation in clinical trials."
• The guide incorporates principles of Good Clinical Practice (GCP) and practical documentation aspects.

Main Results:

• The guide provides an overview of roles in clinical trials (sponsor, investigator, monitor).
• Key documentation areas covered include adverse events, concomitant medication, medical history, and quality control.
• The resource includes a trilingual medical dictionary (English, German, Dutch) and literature recommendations.

Conclusions:

• The guide serves as a self-training textbook and a quick reference for daily practice in clinical trials.
• It is designed to supplement, not replace, hands-on practical training for students.
• The guide is primarily for students but offers significant value to all healthcare professionals engaged in clinical trials.