Beyond the Template
By Margaret Hall - Unicus Regulatory Services Limited
In all forms of writing addressing the needs of the audience is always of paramount importance. In regulatory affairs we have several audiences to consider, including the regulators, the medical profession and the consumer. Testing the understanding and 'fit for purpose' of the patient information leaflet has to be demonstrated by a test of readability and understanding. It can be argued that the ultimate test of understanding of regulatory documents, such as the Quality Summary, and Preclinical and Clinical Overviews is the ease of review by the regulators and the questions or comments in the Assessment Reports. One of our contributors this month has given helpful advice on a suggested detailed template for a clinical overview based on over 5 years experience of writing such documents. However, as regulatory professionals responsible for the submission are there additional steps to ensure that these key documents meet the purpose? Can we find ways of streamlining internal review and approval before submission, which can so often be tedious and unnecessarily complicated causing stress to writers, document reviewers and approvers? Should such documents be prepared at the end of the project or can such documents evolve as data is generated throughout the project?Key Messages and the Skeleton DocumentIn a regulatory Utopia, where time is not critical and there have been no delays with final reports putting the inevitable pressure on the regulatory department to meet the submission deadline, key text messages and ideas on areas of focus for critical analysis can be added to a framework document at an early stage. Before work gets underway in writing the document, the authors can agree with the project team the purpose of the document, the key messages, together with an outline of the supporting data, and any issues that will deserve special emphasis.This may be done following a brain storming meeting to which outside consultants, such as key opinion leaders, investigators or specialist consultants may be invited. The resulting document outline will be the skeleton, from which the key messages evolve and are increasingly supported by data and more detailed rationales as these become available. For this approach to succeed it is critical that there is complete transparency of the early skeleton document to Senior Management who will ultimately review and approve prior to submission.Obtaining the early agreement on the key messages and issues as well as the overall direction of the document enables everyone to share a consistent vision for the content of the document.Good Project PlanningAt the early stages of writing reviews should focus on strategic input for content and conveyance of key messages. A quality check for grammar and style, check against supporting data and then a presentation check against the template can be carried out at the later stages, but suitable time should be allowed for this in the project plan. Good navigational tools such as hyperlinks and a detailed Table of Contents will be useful to the regulatory reviewer and their importance should not be overlooked. The time required to complete a review/approval cycle can be made more efficient, because there are clearly defined stages of review and responsibilities. Numerous drafts and re-writing of content are not a cost effective way of working especially when time will be critical as often these documents can be the rate limiting factors affecting regulatory submission dates. Nearer to the final deadline no major changes should be needed at high level sign off since the important messages have been agreed beforehand and there should be no surprises. TimelinesRealistic timelines need to be factored in so that the process of writing such documents is fully integrated into the regulatory and publishing plans. These key documents are worthy of special attention and should not be rushed towards the end of the project. Sufficient time for review (internal and/or external) must be built into the overall timetable for the submission which should contain all key dates and reviewer responsibilities. Ensuring that key reviewers are actually available at the time they are required is an important logistical consideration. It is very frustrating when key personnel are not available due to conflicting priorities or a misunderstanding as to the importance of the meeting. It should be agreed what level of approval is needed within the company and how the final sign off is to be achieved. Is this a round table review, telecon or a focused sign-off meeting? From a publishing view point, and looking more frequently towards eCTDs, it is important to work within an agreed document template. Also, document management systems will offer version control and approval mechanisms.Formula for Success
A formula for success would be based on good templates, an excellent writer following agreed key messages with controlled review and quality checks. More time would be nice, but with the skills of the regulatory professional the submission will be achieved. Then, it's just a matter of waiting for the assessment ..
