As a regulatory writer, you must stay updated on new policies and evolving best practices for highly technical documents. Continuing education is important for both maintaining and advancing your career . That includes brushing up on everything from medical device writing to pharmaceutical writing. Below, we review the expectations for protocol writing, then follow up with four best practices for success as a regulatory writer who specializes in these types of documents.
It’s easy to get lost in the minutiae of technical documents such as clinical protocols. Remembering the document’s ultimate purpose can help. Clinical study protocols describe everything from a clinical trial’s methodology to statistical considerations. As a “road map” to the clinical trial, a protocol’s ultimate purpose is finding a safe and effective drug for a specific indication.
Create realistic timelines for the type of protocol you’re writing. When setting writing and review expectations, don’t forget to account for multiple reviews! Delays are common, as are edits and adjustments after reviews. By setting a generous, realistic timeline in the beginning, you can avoid frustration and disappointment toward the end of the protocol writing process.
Also, set up granular timelines so that you’ll know immediately if the document goes off schedule. You can set up timelines for each task ranging from “Protocol Draft1” to “Final Team Review Comments” to “Publishing.”
If necessary, negotiate with stakeholders and be clear about the need for a realistic timeline. Sometimes this requires a bit of give and take. Other times, explaining the timeline can be an opportunity to educate your team on the process.
The need for template‑driven protocol development has been well established and is documented in clinical literature. At the industry level, a consistent template can aid submissions, ensure “mapping” between the protocol and the expected data presentation, and enhance readability and consistency for regulatory agency reviewers. However, the template you use may depend on factors such as the clinical trial phase.
The National Institutes of Health (NIH) and the US Food and Drug Administration (FDA) protocol template and e‑protocol writing tool, released in 2017, provide NIH‑funded researchers with structured, detailed guidance for trial design and protocol development for phase II and III clinical trials.
The TransCelerate Common Protocol Template is another useful starting point for many protocol writers. In December 2017, TransCelerate BioPharma issued Release 5 of its common protocol template (CPT) with the stated goals of aligning with the Guideline for Good Clinical Practice, ICH, and European Union requirements and following clinical data standards.
The CPT is a Microsoft (MS) Word document template with headings, instructions for authors, and sample text. It specifies 3 components:
Quality and accuracy are incredibly important in protocol writing (as in all medical writing). As technology and consulting firm Kinetiq noted in a white paper entitled “ Best Practices in Clinical Research Protocol Writing: Eight tips from an IRB member ,” one of the most valuable ways to ensure these is to ask a medical communication colleague who is not involved in the primary research to provide a peer review of the protocol.
But this advice comes with a caveat. Clinical protocols are proprietary documents and should never be shared with anyone who has not signed a confidentiality agreement. Nonetheless, asking a colleague to review the document may help you identify inadequate detail, vague descriptions, or issues with study design or endpoints. If a fellow medical writer or editor is not able to make sense of specific aspects of the protocol, regulatory agencies might have the same problem.
Protocol writing is a rigorous and challenging niche, even for experienced regulatory writers. Success requires a commitment to ongoing learning , fastidious attention to detail, and a strong adherence to ethics and transparency.
April 5, 2021 at 9:00 AM
