Competency In Regulatory Writing- Skills To Enhance – Pubrica

By Author: Mathew
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Growing demand in clinical studies and research makes the author write a precise document to explain their context to their audience i.e. doctors or drug regulators. Regulatory writing is a technical and scientific document which represents pre and post-clinical research.The writing should be clear and accurate else it fails to make good research reporting results in poorly reporting. Regulatory writers write the clinical document based on the regulation of national authority. These documents include Clinical Study Protocols, Informed Consent Form, Investigator Brochures (IBs), risk evaluation and mitigation plans, the Common Technical Document (CTD), and Clinical Study Reports (CSRs). These writers are may not the original authors. They develop the content or the protocol as per the requirement of the client to communicate with the regulatory agencies or to the doctors. Protocols follow a prescribed format of writing a regulatory document which includes the background, design, participants, treatment and outcome along with the statistical determination of the efficiency.

Regulatory writers should coherently articulate ...
... the modifications in case of performing the changes in the documents. These documents include patient information leaflets and prescribing information, clinical reports, and subject articles. The qualification of Regulatory writers will be Doctorate in life science, medical or paramedical professionals, work as the writers at pharmaceutical companies and clinical research organization. The submission documents are of two types, Common Technical Document (CTD) modules and Aggregate safety reports. Clinical and non-clinical summaries, efficiency of treatment and expert’s report are comes under CTD, whereas, policy papers, periodic reports on adverse drug report and periodic safety reports were placed among Aggregate safety reports.
Usually, the regulatory writers work close with doctors, clinical researchers and statisticians. Technically the regulatory writer should be familiar with concepts and terminologies in medical field along with the good writing skill. Since writing skill is important key factor to impress all the audience. Timeliness and adhering to deadline are also another key factor for being a good writer. Adaptability to fast updates and efficiency in adapting rapid changes in protocols important skills. Regulatory writer should have good grounding knowledge in pharmacology, Drug development process, drug safety and reporting guideline prescribed by various regulatory agencies. Another main key factor must be required by regulatory writer is statistics. Statistics was used in all clinical trials and mostly in writing the research outcome. The statistical results gives interpretation about the reliability and criticality of the research question to the clinician which will get implemented in clinical practice. Every medical writers should have basic understandings about confidence intervals, regression analyses, randomization schemes, P values, and t-tests. The writer should have knowledge about dissection of raw data and communicate effectively in the document. The collection and management of regulatory documents should be familiar to the writer. Along with all these knowledge, the writer should harness the knowledge to enhance the document through their education and experience of regulatory science(Clemow B., 2011). Writer should poses solid background knowledge about writing the respective specialization. Not alone advanced degree, a formal degree with solid background is enough for writing variety of research essentials.

Beyond the education, few other skills should be endorsed by the writer. For example Editorial competence. This refined skill helps the writer in writing the document to reduce errors and ensure comprehensiveness of the document. Computational skills helps the writer to develop the knowledge about the software which helps to extract and analyze the data and it benefits in interacting the results with the other members of the team(Heisel-Stoehr & Schindler, 2012). This skill can be developed by developed by self-learning or onsite experience of the writer in documenting the needs. Regulatory writer with advance knowledge with the statistics is added benefit. This helps in bring out the outcome in more effective way. Above all, the writer should be familiar with the guideline and regulation of the regulatory needs of a government body gives clear image of the work flow in accurate way.

Conclusion :
Regulatory writer was considered as the main communicator among the research group and the governing body. Collaboration of researchers, attention to the details and timeliness are the key skills important the writer. Overall, the writer should have interest in handling data; possess the quality and the achievement will be easily derived.

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