Guidelines and Recommendations: A Document's Backbone
Dr. Hetal Shah
1 module
English
Lifetime access
Essentials of Regulatory and Research Guidelines for Medical Writing
Overview
A pre-recorded 1-hour 6-minute expert session designed to provide a concise introduction to key guidelines, recommendations, and templates used in medical writing and regulatory documents. This session was part of the OPEN HOUSE Events 2022 at MeWriT Academy and was recorded in December 2022.
Delivered by Dr. Hetal Shah, the lecture covers the backbone of regulatory and research documentation, including ICH, SPIRIT, CTD prism, ICH M4, and reporting guidelines such as CONSORT, STROBE, PRISMA, and CARE. Participants are introduced to guidance documents, templates, and checklists essential for protocols, ICFs, IBs, CSRs, and SAPs. The session also includes rapid-fire questions and quizzes to reinforce learning, making it perfect for aspiring medical writers, clinical research professionals, and life science students seeking a structured understanding of documentation standards.
Key Highlights
Foundational role of guidelines and recommendations in medical documents
Introduction to guidance documents and templates
Overview of ICH and SPIRIT guidelines
Application of guidelines in Protocol, ICF, IB, CSR, and SAP
Brief insight into CTD prism and ICH M4
Introduction to reporting guidelines via EQUATOR Network
Key publication guidelines: CONSORT, STROBE, PRISMA, and CARE
Essentials of ICMJE and GPP for research publication
What you will learn
Guidance, Recommendations & Templates
Learn the purpose of guidance documents and how templatein structured writing.
ICH & SPIRIT Overview
Get introduced to key ICH guidelines and the SPIRIT statement and their role in protocol and clinical research documentation.
Guidelines in Regulatory Documents
Understand how guidelines are applied to core documents such as Protocol, ICF, IB, CSR, and SAP.
CTD Prism & ICH M4 (Brief)
Gain a basic understanding of the CTD structure and the importance of ICH M4 in regulatory submissions.
Reporting Guidelines (EQUATOR Network)
Learn about major reporting standards including CONSORT, STROBE, PRISMA, and CARE and their relevance to research publication.
Publication Ethics & Best Practices
Get introduced to essential publication guidelines such as ICMJE and GPP for ethical and responsible writing.
Rapid-Fire & Knowledge Check-Quizzes
Reinforce key concepts through quick explanations and focused topic coverage & strengthen learning with quizzes conducted during and at the end of the session.
Modules
Guidelines and Recommendations: A document's Backbone
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