Regulatory medical writers are key personnel in delivering quality regulatory documents that advance science and medicine, keeping patients safe and informed about the benefits and risks of pharmaceutical products.
Regulatory writing is an important and challenging medical writing specialty. AMWA’s Value of Medical Writing Workgroup identified quality, timelines, and interactions with stakeholders as common barriers to success.
AMWA’s Measures of Success Toolkit is a collection of resources that explores the regulatory writing environment, offering expert advice on achieving quality, managing timelines, and handling interactions with stakeholders.
Creating High-Quality Regulatory Documents
How do medical writers ensure the quality of the documents they write and edit? Once a quality standard is set, there are several layers of review that help guarantee quality. Medical writers can apply quality metrics and be on the lookout for common quality issues.
Definition of Quality
A high-quality regulatory document is both similar to and distinct from other medical and scientific documents. Readability is key. All documents need to be consistent, cohesive, and succinct. They need to be meticulously organized, formatted, and edited for style, punctuation, and grammar. In addition, regulatory documents also need to meet specific requirements of regulatory agencies.
Layers of Review
When undertaking a review, medical writers can use tools such as AMWA’s Medical Editing Checklist. The most common levels of review for regulatory documents include
Self-Check
Run a spelling/grammar check, update an abbreviation list, check if acronyms are spelled out on the first mention, make sure company style is applied, double-check headers, footers, version information, protocol numbers, and dates. Be sure to take breaks and review with fresh eyes.
Team Review
Identify a team member from each required function who will review the document. Note: It’s important to cover each aspect of the document, but as we will discuss later, multiple reviewers can affect the number of comments, slow the timeline, and dilute the responsibility.
Quality Control Review
Even the best medical writers can miss errors, which is why we always want fresh eyes—someone different from the author—conducting quality control (QC) reviews. Generally, a QC review covers 100% of the document, but it can also be a focused review of a section. The author hands over a document with an explanation of the background, project history, team preferences, common problem areas, a protocol for reporting findings, source documents, previous versions, templates, and style guides. At this stage, a QC checklist should be used, and an appropriate deadline should be agreed upon.
Quality Assurance Review
A quality assurance review is another step that involves checking to see that all the processes were followed and that all QC and team comments have been addressed. The entire document may not require a quality assurance review.
Quality Metrics
Written or verbal complaints from regulatory reviewers could compromise the process and lead to consequences. That is why quality metrics are used to quantify the process by noting such factors as
- The number and substance of QC findings
- The number of consistency errors
- The number of rounds of review required to complete the document
- The number of clarification letters and/or amendments that were necessary
- Formal or informal complaints from team reviewers and feedback from regulatory agents
Common Quality Issues
Some of the most common quality issues found in regulatory documents include
- Lack of organization or clarity
- Language usage errors
- Poorly presented tables and graphs
- Data errors such as inconsistencies and transcription errors
- Incomplete or overly repetitive content
- Incorrect formatting
- Bad or insufficient links
- Lack of adherence to the company style guide or regulatory guidance documents
Timelines for Regulatory Documents
One of the most important tasks for regulatory medical writers is to help organize stakeholders and reviewers to adhere to an appropriate timeline. The timelines for regulatory documents vary and can sometimes be compressed if processes overlap. The Measures of Success Toolkit provides sample timelines for the following common regulatory documents:
- Clinical Study Report: 52–60 working days
- Protocol Amendment (1 draft): 24–40 days
- Investigator’s Brochure (2 drafts): 35–50 days
- CSR that requires senior management review (3 drafts): 43–60 days
Stages can be overlapped and timelines accelerated by using draft data. The benefit of this is a faster turnaround. However, using draft data can be inefficient and may introduce errors and present workflow/version control issues. Our experts recommend consulting with a biostatistics person and delaying QC until final data are available.
Multiple Writers
Sometimes timelines are accelerated by dividing the work between two or more writers. However, this should be done carefully by first finalizing a robust mock meeting to discuss key messages, and clearly dividing responsibilities among writers. Writers should review one another’s work to ensure consistency and quality.
Balancing Quality and Speed
Timelines are important, but it is important to note that moving faster can compromise quality. When timelines are compressed, team reviewers have less time to comment, medical writers get fewer days to reconcile comments and follow up on queries, and the person doing QC has fewer days to review. A rushed project could be costly if time is needed to rework a document after a negative response from a health authority reviewer.
To avoid compromising quality for speed, limit the number of individuals involved with reviews, prioritize and be selective of comments at comment resolution meetings, address comments directly with subject matter experts (SMEs), and include someone who has the authority to determine whether a particular change is necessary.
Although there are ways to accelerate a timeline, our experts do not recommend proceeding without final data, trying to work with too many writers, having project managers or project leaders check in daily, or having multiple reviewers; these can backfire and compromise quality.
Advice from the Experts
The Measures of Success Toolkit includes advice from seasoned professionals who have experience creating quality documents and meeting timelines.
It also includes critical information on how to navigate the process of creating excellent regulatory documents by controlling interactions with key stakeholders.
The Role of Medical Writers and Other Stakeholders
Regulatory medical writers are key to the process of developing regulatory documents by writing clearly, concisely, and consistently. Medical writers also analyze and interpret data while understanding statistical concepts and regulatory requirements.
They also provide leadership by shepherding documents through multiple iterations and reviews by numerous stakeholders.
Clear communication and diplomacy are important for keeping regulatory projects on task. For example, our experts recommend assigning one reviewer to each of the key functions, making sure each function is covered. However, as the old saying goes, too many cooks can spoil the broth. Multiple reviewers can increase the number of comments and lengthen the timeline as the medical writer tries to resolve discrepancies.
When Are Stakeholders Involved?
Stakeholders are involved throughout the process of creating a regulatory medical document, from document planning at a kick-off meeting to document drafting, document reviews, and finalization.
Resources for Regulatory Medical Writers
AMWA has a number of resources targeted and created by and for regulatory medical writers.
The Medical Communicators’ Guide to Regulatory Writing introduces prospective regulatory writers to the skill set, documents, and resources needed for a successful career.
AMWA’s Medical Editing Checklist helps medical communicators in all areas avoid unnecessary errors and meet requirements for the submission of documents.
The Measures of Success Toolkit includes the details of quality, timelines, and stakeholder involvement, providing expert insights into this critical medical writing specialty.
A Relevant Resource for AMWA Members
In any specialty, a targeted checklist can help medical communicators achieve high-quality results.
AMWA’s Clinical Study Protocol Content & Quality Checklist is a tool regulatory medical writers use to ensure that all the required content in a study protocol aligns with the study protocol’s objectives and criteria. It helps medical communicators comply with the specific requirements of regulators.
AMWA acknowledges the contributions of Kavita R. Garg, MPharm, MBA, for peer review in the development of this AMWA resource.
The following checklist is an AMWA Members-Only Resource.
If you're a member of the American Medical Writers Association (AMWA) and don't see the checklist content below, click to submit your AMWA member profile email to download and view it.
