SIX BEST PRACTICES FOLLOWED IN REGULATORY WRITING

 

Regulatory writing is the development of preclinical and clinical research proceedings into documents following the guidance standards and description required for validation of a product in the clinical study. Experts from medical and scientific disciplines are generally employed to play this major role. The regulatory writer mainly focuses on writing the technical documents related to clinical trials, their results, background, pre-trial and safety information. Following are the below mentioned good practices essential while drafting the technical documents;

·         Clear information for clinical study

The ideas have to be clearly explained and expressed in simple terms so that it is clearly understood by the target audience such as the clinical site staffs, investigators and regulatory authorities. Regulatory writer should have prime focus on the objectives of the clinical study with supported objective evidence. Application and benefits of the clinical study including its future outcomes should be clearly mentioned by the writer in an easily understandable way.  All the steps should be supported by evidence so that the document is comprehensible to the target audience. Other qualities include a carefully defined purpose, flawless sentences, coherent organization and appropriate word choice.

·         Simplicity in writing

One of the main secrets in regulatory writing is to write the clinical document in a simple easy-to-understand manner so that it is clearly understood by the target audience without facing any difficulty. The document should include all the necessary information in simple terms so that it appeals a larger audience easily. However, few complexities cannot be avoided but too many complexities throughout the story are often questionable. Simplicity in writing means to convey the message in simpler and clearer terms when the writer has sufficient knowledge of the purpose of the study.

·         Flawless writing

Proper flawless writings are authenticated, convincing and well- researched. Critical regulatory writers inculcate the practice of repeated reviewing and proofreading. Repeated reading helps to eliminate common errors and improper punctuation. Spelling error does not stop acceptance from the regulatory submission, however, the professionalism of the submitting party may be questioned by the reviewers.

A standard format or style guide is available for managing the submission. The template has built-in styles for headers and footers, tables and figure titles along with headers that should be used while preparing the regulatory documents. The information needs to be properly organized, easily readable and properly sanctioned. While the writing is presented in electronic formats, navigation has to be ensured for quick and easy identification of the specific points chosen by the reviewer.

·         Adequate context

Majority of the reviewers are from various disciplines, hence it is not likely that a particular reviewer will read the entire document from beginning till end. The reviewer reads the document at specific points relevant to their discipline. It is crucial for the writer to keep this in mind and should always cross reference important information required for context at multiple places across the document. Too much redundancy is not at all acceptable in regulatory writing.

·         Uniformity in writing

The writing has to be exclusive and be unity of voice. It has to be expressed in such a manner as if only one person has documented it. If there is lack of cohesion and no unity of voice, the reviewer considers the writing as “out of the story” and has the opinion of rejecting the submission instead of accepting the submission of the document.

·         Uniform writing with team effort

Regulatory writing encompasses a team effort where various scientific and medical experts provide ideas before documentation. Experienced regulatory writers are skilled to understand, interpret and represent complicated statistical analysis and scientific data and provide effective guidance. The document should have clarity and detailed description of the study so that it gives an overview of the study concerned.

·         Perfect understanding of the regulatory topic

It is commonly misinterpreted that a relevant degree or years of experience is essential to be efficient for writing a particular regulatory topic. However, fundamental and clear understanding of the topic is a requisite rather than technical expertise.

Regulatory writing is an important sphere of WorkSure^® where the scientific and medical documents related to the clinical study are well written for the targeted audience.  These include various brochures, protocols (with detailed technical/laboratory/medical procedures and safety reporting) and amendments, Case Report Forms (CRF), Informed Consent Forms (ICF), Clinical Study Report (CSR), clinical trials, marketing application approval with clarity and precision.