For any clinical regulatory writer, compiling the appendices for a clinical study report (CSR) can feel like a daunting task, but it doesn’t have to be. To make this task easier and less time consuming you need to start thinking about it before you even begin to write the CSR.
This blog describes a possible workflow for publishing a final CSR in modular format, ie, individual PDF files for the CSR body (Sections 1 to 15, excluding synopsis), CSR synopsis, and each CSR appendix (16.X.X).
Quanticate's medical writing services include regulatory writing and are industry leading in the pharmaceutical space. We have expensive experience in the creation and submissions of regulatory documents including the generation of Clinical Study Reports. If you have a need for these types of services please Submit a RFI and member of our Business Development team will be in touch with you shortly.
International Council for Harmonisation (ICH) guideline Efficacy 3 (E3) Structure and Content of Clinical Study Reports
ICH E3 Guideline: Structure and Content of Clinical Study Reports Questions & Answers (R1).
FDA Guidance for Industry Providing Regulatory Submissions in Electronic Format – General Considerations (Draft Guidance)
ICH M2 EWG Electronic Common Technical Document Specification and Guidance for Industry
ICH M4 (R3) Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
Authors note: This blog was originally published on 10/05/2011 and has since been updated.
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