Clinical study report

For the regulatory compliant completion of a clinical study, according to §13 Abs. 9 of the GCP regulation, a summary of defined key points of a clinical study is required, such as: Introduction, research question, description of the applied methods and study design and all essential results of the clinical study. The Clinical Study Report must make it possible to evaluate the study.

The clinical study report should answer all primary and secondary questions so that conclusions can be drawn. With the help of the Clinical Study Report, the regulatory authorities also evaluate the results of the study, which is particularly important for registration studies. Formal requirements apply to the Clinical Study Report, regardless of whether it is a commercial or non-commercial study.

The requirements of the authorities vary, so that the BfArM requires a listing of all Adverse Events, Serious Adverse Events, Adverse Reactions, Serious Adverse Reactions and the SARs/ SUSARs. While according to the BfArM a publication with a supplementary list of the listed events is possible as an alternative to the Clinical Study Report, according to the PEI a synopsis with all data must be submitted. The requirements of the responsible ethics committees are not uniform, so that some ethics committees demand a clinical study report or its synopsis; others accept a publication.

For pivotal studies a full clinical study report is required according to ICH Guideline E3.