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.
Reviewing the Purpose of Protocol Writing
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.
4 Best Practices for Protocol Writing
1. Begin with the end in mind.
The clinical study protocol is the written plan intended for research personnel. It will be used by a variety of stakeholders during the clinical trial process. The clinical investigators will be responsible for implementing the protocol exactly as intended. The institutional review boards (IRBs) will rely on the protocol to ensure the well-being
of subjects in the trials. Other stakeholders include data managers, the clinical study manager, and the statistician, among others involved in the study. Eventually, the clinical study protocol will also serve as an outline to help summarize the study in scientific manuscripts, presentations, or in documents that communicate the results of clinical trials to patients.
As you plan and write the protocol, remember to keep the document’s end purpose(s) in mind. The protocol should spell out all the critical details about the research, including:
- Background and rationale for conducting the study
- Objectives and endpoints
- Study design and methods
- Patient populations – that is, who will be enrolled in the trial
- Overall organization of the trial; for example, how often subjects will be seen and what evaluations and medications they will receive
2. Be realistic with your timelines.
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.
3. Use the right template.
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.
NIH and FDA Protocol Template
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.
TransCelerate Common Protocol Template
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:
- Core backbone headings (level 1 headings that are intended to always be used)
- Libraries (repositories for specific content)
- Appendices (headings/locations for information that may be deleted if not used)
4. Engage in quality control.
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.
