Students' guide to documentation in clinical trials.

Heck J, Rath AK, Wons K, Schumacher C, Kutschenko A, Noltemeyer N, Ulaganathan S, Voßiek LJ, Hijma H, van Smeden J, Schröder C, Stichtenoth DO, Wedemeyer H, Schindler C, Bosch JJ

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.