Decoding the role of medical writer: Exploring the key components of research and regulatory documents

Registration ID: IJNRD_212206

Published ID: IJNRD2401086

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Sampreethi Harikeerthi

Medical writing, clinical trial, regulatory documents, drug development

A medical writer involves in writing/preparing various types of documents which includes educational and promotional literature, drug or disease related documents, healthcare websites, health related magazines and articles, regulatory and research related documents. Although they majorly work pharmaceutical and research organisations, there are various streams where a medical writer plays a vital role. This article majorly focuses on the design and components of Protocol, Investigator’s Brochure(IB), Informed consent form(ICF), clinical study reports(CSR), common technical document(CTD) and Case report form(CRF) which are the most prominent documents in the field of medical writing and to provide a basic idea to the aspiring medical writers. A protocol is a document that forms the basis of any research or study. Investigator’s Brochure provides overall information about the investigational medical product its dose, frequency, handling, administration etc. Informed consent form is a voluntary consent/permission given by the subjects to participate in the study. The CTD is a format, that is internationally accepted for the submission of new drug application to the regulatory authority. A CRF is used to collect data from subjects who are involved in the trial. There are also many other documents like IMPDs, research proposals, subject narratives etc. which are beyond the scope of this article. In conclusion, for a medical writer apart from having sound knowledge in medical science and writing skills it is consequential to have thorough knowledge of specific requirements of documents, and being well informed with the relevant guidelines

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Sampreethi Harikeerthi (January-2024). Decoding the role of medical writer: Exploring the key components of research and regulatory documents. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 9(1), a740-a744. https://ijnrd.org/papers/IJNRD2401086.pdf

Volume 9 Issue 1, January-2024

Pages : a740-a744

Paper Reg. ID: IJNRD_212206

Published Paper Id: IJNRD2401086

Research Area: Pharmacy

Author Type: Indian Author

Country: Ranga Reddy, Telangana, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2401086.pdf

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