How to document a clinical study and avoid common mistakes in study conduct?

Abstract

Study conduct is an important and sensitive part of a clinical research project. Adequate planning is paramount to avoid mistakes with potential legal or quality-related consequences. Principal investigators should comply with legal requirements to avoid an early discontinuation of the study. Regulatory binders should be available on-site at any time of the study both in case of an audit and to be consulted by the study team if required. All study activities, from patient eligibility check to data collection through informed consent and study visits, should be carefully planned and scheduled in agreement with the study team prior to first patient enrollment. To allow for a high-quality study, which would deserve to be published in a high-ranked journal, a professional preparation is the key to success.