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You have options!

Your study may not need a full CSR for your marketing application. Depending on the type of study you are conducting, or its intended purpose, it may only be necessary to submit an abbreviated version of the full ICH E3 CSR.

The FDA and EMA have produced a series of guidelines and legislation aimed at clarifying when anything less than a complete CSR may be submitted for their review.

In brief, a full CSR would include both efficacy and safety data, but there are instances when it is preferable to report parts of the study at a later date in a supplemental CSR.

Or, if the efficacy and clinical pharmacology data are not needed to support the efficacy claim of your treatment, you could choose between writing an abbreviated CSR or a synoptic report.

The complete regulatory guidelines and legislation are linked below to help you determine which report is right for your study. The guidelines also recommend that, when in doubt, to consult the relevant regulatory authority.

Each of these options could save valuable time in reporting only the necessary information to the regulatory authorities and help bring your innovative treatment to market sooner.

Further Reading

European Medicines Agency. ICH Topic E 3 Structure and Content of Clinical Study Reports. Note for guidance on structure and content of clinical study reports (CPMP/ICH/137/95). 1996. Click to read [PDF] (Accessed: 17 July 2019).

Food and Drug Administration. Guideline for the format and content of the clinical and statistical sections of an application. 1988. Click to read [PDF] (Accessed: 17 July 2019).

Food and Drug Administration. Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications. 1999. Click to read [PDF] (Accessed: 17 July 2019).

Documents need to be written | Europital can write them for you

Contact David Bruce, our Business Development Manager, to learn more about how we can help you with all your Medical Writing needs.

David Bruce MBA PhD 
Business Development Manager

T: +44 (0) 1743 741728
M: +44 (0) 7850 123151
E: [email protected] 
W: https://europital.com