Final report

A final report, also called Clinical Study Report, Final Report or CSR for short, is required for the regulatory compliant completion of a clinical study according to §13 paragraph 9 of the GCP regulation. The final report must make it possible to evaluate the study.

The final report contains in detail an introduction, the research question, a description of the methods used, the study design and all essential results of the clinical study. The results should be statistically evaluated and all primary and secondary questions should be answered so that conclusions can be drawn. With the help of the CSR, the regulatory authorities also evaluate the outcome of the study, which is particularly important for registration studies. Formal requirements apply to the Clinical Study Reports, regardless of whether the study is a commercial or non-commercial study.

The requirements of the authorities are different, so that the BfArM demands a listing of all Adverse Events, Serious Adverse Events, Adverse Reactions, Serious Adverse Reactions and the SAR`s / SUSAR`s. While according to the BfArM, as an alternative to the final report, a publication with a supplementary list of the listed events is possible, according to the PEI a synopsis with all data must be submitted. The requirements of the competent ethics committees are not uniform, so that some ethics committees demand a final report or its synopsis; others, however, accept a publication.

For registration studies, a full CSR is required according to ICH Guideline E3.

The Clinical Study Report can be written either by the investigators, the sponsor or a Clinical Research Organisation (CRO).