Students’ guide to documentation in clinical trials

European Journal of Clinical Pharmacology, vol. 78, pp. 1861–1862

Abstract

PURPOSE: In the wake of the coronavirus disease 2019 (COVID-19) pandemic, support in clinical trials by students of human medicine and related disciplines has become of even greater importance than in pre-pandemic times. Documentation in clinical trials adheres to the principles of Good Clinical Practice (GCP), and healthcare professionals involved in the conduct of clinical trials-including students-are obliged to perform documentation in accordance with GCP principles. Unprecedented challenges have arisen with regard to the appropriate training of students as training courses in presence had largely to be suspended due to social-distancing regulations during the heyday of the COVID-19 pandemic. Therefore, novel training formats and self-study training materials for students working in clinical trials are urgently warranted. METHODS: To overcome this shortcoming and to define a common quality standard, an interdisciplinary, multiprofessional (physicians, study nurses, medical students), and binational (Germany, The Netherlands) expert panel convened and devised the Students' guide to documentation in clinical trials. RESULTS: Following a brief description of the different roles in clinical trials (e.g., sponsor, (principal) investigator, monitor) and an introduction into the principles of GCP, the documentation of adverse events, concomitant medication, medical history, and quality control are comprehensively discussed. The Guide concludes with a trilingual medical dictionary (English, German, Dutch) and with recommendations of pertinent literature for further reading. CONCLUSION: Serving both as textbook for self-training and as (quick-) reference work for the daily routine, the Guide has specifically been designed to complement, but not to replace practical training courses for students. While primarily addressed at students of human medicine and related disciplines, the Guide can also be of high relevance and utility to other healthcare professionals involved in the conduct of clinical trials.

Authors 15

1. Johannes Heck corresponding

   Medizinische Hochschule Hannover

   Affiliation as printed

   Center for Clinical Trials, Hannover Medical School, Hannover, Germany. heck.johannes@mh-hannover.de

   Institute for Clinical Pharmacology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany. heck.johannes@mh-hannover.de

   Center for Clinical Trials, Hannover Medical School, Hannover, Germany

2. Ann-Kathrin Rath

   Medizinische Hochschule Hannover

   Affiliation as printed

   Center for Clinical Trials, Hannover Medical School, Hannover, Germany

   Department for Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany

3. Katrin Wons

   Medizinische Hochschule Hannover

   Affiliation as printed

   Center for Clinical Trials, Hannover Medical School, Hannover, Germany

4. Carsten Schumacher

   Medizinische Hochschule Hannover

   Affiliation as printed

   Center for Clinical Trials, Hannover Medical School, Hannover, Germany

5. Anna Kutschenko

   Medizinische Hochschule Hannover

   Affiliation as printed

   Center for Clinical Trials, Hannover Medical School, Hannover, Germany

6. Nina Noltemeyer

   Medizinische Hochschule Hannover

   Affiliation as printed

   Center for Clinical Trials, Hannover Medical School, Hannover, Germany

7. Sarana Ulaganathan

   Medizinische Hochschule Hannover

   Affiliation as printed

   Center for Clinical Trials, Hannover Medical School, Hannover, Germany

8. Luca Jan Voßiek

   Medizinische Hochschule Hannover

   Affiliation as printed

   Center for Clinical Trials, Hannover Medical School, Hannover, Germany

9. Hemme J. Hijma Aachen Centre for Human Drug Research (CHDR)

   Leiden University Medical Center · Centre for Human Drug Research

   Affiliation as printed

   Centre for Human Drug Research, Leiden, The Netherlands

   Leiden University Medical Center, Leiden, The Netherlands

10. Jeroen van Smeden Aachen Centre for Human Drug Research (CHDR)

    Leiden University Medical Center · Centre for Human Drug Research

    Affiliation as printed

    Centre for Human Drug Research, Leiden, The Netherlands

    Leiden University Medical Center, Leiden, The Netherlands

11. Christoph Schröder

    Medizinische Hochschule Hannover

    Affiliation as printed

    Institute for Clinical Pharmacology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany

    Institute for Clinical Pharmacology, Hannover Medical School, Hannover, Germany

12. Dirk O. Stichtenoth

    Medizinische Hochschule Hannover

    Affiliation as printed

    Institute for Clinical Pharmacology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany

    Institute for Clinical Pharmacology, Hannover Medical School, Hannover, Germany

13. Heiner Wedemeyer

    Medizinische Hochschule Hannover

    Affiliation as printed

    Department for Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany

14. Christoph Schindler

    Medizinische Hochschule Hannover

    Affiliation as printed

    Center for Clinical Trials, Hannover Medical School, Hannover, Germany

15. Jacobus J. Bosch Aachen Centre for Human Drug Research (CHDR)

    Leiden University Medical Center · Medizinische Hochschule Hannover · Centre for Human Drug Research

    Affiliation as printed

    Center for Clinical Trials, Hannover Medical School, Hannover, Germany

    Centre for Human Drug Research, Leiden, The Netherlands

    Leiden University Medical Center, Leiden, The Netherlands