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A Beginner’s Guide to Key Clinical Documents in Drug Development

Drug Development
Workshop profile:
This workshop is designed for people who are new to medical writing in general, and those who are new to regulatory writing.
For new medical writers, the number of documents prepared during the course of drug development can be overwhelming. The objective of this workshop is to give new medical writers an overview of some of the key clinical documents that they may be asked to prepare. The workshop will explain the purpose of the different documents, how they all fit together, and how this affects the way that each document is written.
The role of each of the documents listed below in the drug development process will be described in the order they are developed: • Investigator’s brochure (IB) • Investigational medicinal product dossier (IMPD) • Clinical study synopsis • Clinical study protocol (statistical analysis plans, case report forms, patient information and informed consent forms) • Clinical study report (CSR) • Paediatric investigation plan (PIP) • Common technical document (CTD) clinical overview (Section 2.5) and clinical summary (Section 2.7) • Summary of product characteristics (SPC) • Patient information leaflets (PILs) • Risk management plan (RMP) • Periodic safety update report (PSURs) and drug safety update reports (DSURs) For each type of document, the following will be summarised: • The purpose of the document: who will use it and how • How the purpose affects the writing • Who is involved in producing it and the role of the medical writer in its preparation • Where the information in each document comes from • How it fits with the other documents • Similarities and differences to other documents