Description of naming conventions for clinical study report files, if applicable 11. Names and contact information of sponsor personnel with whom the writer will work to draft the CSR 12. Information on how to store, archive, and circulate draft and final CSR, if applicable 13. The documents that medical writers need to produce a fully ICH-compliant CSR are provided below in two categories, Tools and Administrative Information, and, content : Tools and Administrative Information 1. Protocol number or study number 2.
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This leads to frustration and causes delays in the CSRs development. In turn, delayed CSR completion can extend the actual submission date of the products eCTD/marketing application-because CSRs are required content. Clinical study report project timeline 8. For interim reports, the cutoff date for clinical study data to be presented in the interim report 9. Name, title, and contact information for sponsors representative who will approve and sign CSR 10. Benefits of Certification, by becoming an MWC, you can give an employer or client increased confidence in your credibility and knowledge of medical writing. Show your commitment to continued professional development in the field of medical writing. Clinical study report template in Microsoft, word, if available 6. Adverse event (AE) and/or serious adverse event (SAE) narrative template, if applicable (ie, if there were AEs and/or SAEs reported in the clinical study, and if those events will be written as narratives for inclusion in the CSR) 7. This research established key areas of knowledge, skills, and abilities required for practice within the medical writing community. As a result, it was determined that by passing the Medical Writing Certification Examination, professionals who hold this credential demonstrate their understanding of medical writing core competencies.