The clinical study report (CSR) is a crucial document in the drug development and regulatory submission process.
According to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline E3, a CSR is an integrated report of a study of any therapeutic, prophylactic or diagnostic agent in which the clinical and statistical description, presentations and analyses are provided in a single report, incorporating tables and figures into the main text of the report and in appendices.
The CSR conducted upon human beings is a detailed report should include an explanation of the critical design features, the plan, methods and conduct of the study, individual patient data and details of analytical methods.
Why to write CSR reports:
As per ICH – “Whether the trial is completed or prematurely terminated, the sponsor should ensure that the clinical trial reports are prepared and provided to the regulatory agency(ies) as required by the applicable regulatory requirement(s)”
The CSR will support a future marketing authorisation application.
When to submit CSR reports:
Sponsors must submit the CSR summary within one year of the end of the clinical trial involving adults and within six months of end of trial involving paediatric patients to regulatory authorities and ethics committees.
Formats for CSR submission: Most pharmaceutical companies have their own CSR templates and guidance documents within which ICH E3 is contextualised and interpreted.
• Full study report (Complete E3 report) – for all ICH regions
• Abbreviated reports and Synopses reports are acceptable by US FDA.
The content of CSRs is detailed in the ICH guideline E3
Refer below document for detailed guidelines.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e3-structure-and-content-clinical-study-reports
