Clinical study reports and other regulatory documents

Clinical study reports (CSRs) are documents submitted to regulators to obtain marketing licenses for drugs and biologics and are a key source of detailed trial information, providing much more information than other sources, particularly adverse event data. CSRs can be long (up to 10,000s of pages), but they are generally highly structured, and where they exist, they are likely to be the most comprehensive and complete single source of information about a trial. A key resource for Cochrane Review Group staff and authors is:

 Using clinical study reports in Cochrane Reviews Starter Pack   

The Starter Pack includes key resources, such as guidance, training and support, as well as examples of published Reviews that have used clinical study reports.

Cochrane Scientific Committee recommendation (see the meeting minutes and supporting document from February 2018 and Full statement, February 2018):
Committee members agreed this data was important in tackling reporting bias. Further development of methods and tools were required that identifies where more evidence is needed as well as where Cochrane should concentrate its energies. The report’s findings were accepted in principle by the Committee. However, further consideration of roll out and implementation within the main body of Cochrane required the input of both Governing Board (resources) and Editorial Board (implementation requirements).

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