pipet2pen: Mastering the art of CSR writing - By Ajay K Malik

A clinical study report (CSR) is a “complete” summary of the safety and efficacy data obtained in a clinical study in patients. The investigational drug may be a therapeutic, a prophylactic or a diagnostic agent. A CSR is an “integrated” report since it documents all the information pertaining to a study, including methodology, test article details, patient data and outcome; also attached as appendices are protocol, investigator-related information, sample case report form, tables and figures, statistical methods, statistical reports, etc.

CSRs are generally co-authored, and it’s a team exercise.

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Mastering the art of CSR writing

August 30, 2011 by Ajay K Malik

A clinical study report (CSR) is a “complete” summary of the safety and efficacy data obtained in a clinical study in patients. The investigational drug may be a therapeutic, a prophylactic or a diagnostic agent. A CSR is an “integrated” report since it documents all the information pertaining to a study, including methodology, test article details, patient data and outcome; also attached as appendices are protocol, investigator-related information, sample case report form, tables and figures, statistical methods, statistical reports, etc.

CSRs are generally co-authored, and it’s a team exercise.

An eCTD submission or an FDA marketing application may contain multiple CSRs along with clinical summaries and narratives.

Before attempting to assemble a CSR, it is helpful to go through a checklist of items needed to prepare this document. Susan Caldwell on her blog Biotech Ink Blot lists 48 pieces of information that should be available to a medical writer to complete the task.

The design of a CSR is very similar to a peer-reviewed manuscript except that its format is based on the ICH-E3 guidelines and the targeted audience is FDA. ICH-E3 provides a skeleton (template or sections) specifying where each piece of information should go, and the regulatory agency (US FDA, EU, etc.) specifies the format.

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