Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics (eBook)

Regulatory writing fundamentals.- Developing a target.- Getting started.- Regulatory writing tips.- Templates and style guides: The nuts and bolts of regulatory documents.- Document review.- Source documents.- Protocols.- Clinical study reports.- Integrated documents.- Investigator’s brochures.- Investigational medicinal products dossier.- Integrated summaries of safety and efficacy.- Informed consent forms.- Regulatory submissions.- Global submissions: The common technical document.- Clinical trial procedures and approval processes in Japan.- Region-specific submissions: United States of America.

Template contents (S. 34-35)

The purpose of a template is to guide and direct the format and content of a regulatory document. A template should not be thought of as a ?ll-in-the-blank exercise. It may contain boilerplate text (ie, text that describes a concept that does not change and so therefore cannot be modi?ed), and sections completely devoid of text. Neither implies a page of text with ?ll-in blanks. Each document, whether a protocol, investigator’s brochure, clinical study report, informed consent form, or summary document must be considered carefully. The writer needs to consider the appropriate contents – and level of detail – for each section and subsection, even if it is to refer the reader to another section or to state that the expected test or procedure (for example) was not conducted as part of the study. The sponsor should have a policy on whether to permit the deletion of irrelevant sections or subsections as a best practice.

Each template should adhere to regulatory guidances, if applicable. That is, any topics speci?ed in the guidance document should have a place in the template, however, with the exception of the guidance for the outline of the Common Technical Document (CTD) [1], the topics do not need to be in the same order as in the guidance document. See Appendices II, X, and XI for examples of protocol, clinical study report, and investigator’s brochure outlines. Precise heading titles and the order of topics within the template may vary by sponsor and by product. Additionally, the depth of coverage of a topic is subject to interpretation by the sponsor.

Thus, two sponsors can have different interpretations of a single section of a guidance document, or they might choose to implement selective portions of the guidance. The danger, of course, is in not providing information that regulatory agencies expect to ?nd. Guidance documents, while somewhat ?exible, occasionally contain redundant sections. It is possible to avoid the redundancy by simply referring the reader (ie, regulatory reviewer) to another section of the document.

Clearly, the writer needs to read the boilerplate language and ensure that the text is accurate for the study. Boilerplate language should only be incorporated in templates when the language is not expected to change. It is recommended that any variance from approved boilerplate language in the template require a written explanation to the document review committee at the time of document review and approval by the committee.One additional consideration during template development may facilitate the preparation of subsequent documents: Construct templates so that a single document can have multiple uses. For example, develop a format for the nonclinical