Prior to starting your project, there are several key elements which will require addressing. As will any process based project, first and foremost, we will need to fully understand the overall objective which you or the sponsor needs to attain. The overall scope and key project milestones including original project plan, data to be analysed and the anticipated approval process.
In simple terms, writing scientific documents involves the analysis of data and then presenting it using text, tables and graphs. When analysing the large amounts of highly technical data we normally facilitate a meeting between the functional experts. The conclusions raised by the medical writer in collaboration with the functional team will then be assessed by the project reviewer.
Creating the first draft
Creating the first draft may involve input from different specialities such as biostatistics, pharmacokinetics, clinical and nonclinical studies, regulatory compliance and safety. At this stage a medical writer would create bullet points for the first draft from the data received from the functional experts. Each separate section is then supplemented with position statements.
Supplementary to primary core text, documents may also contain a number of appendices. In order to achieve and maintain a high consistency between the various documents a pre-designed template and a style guide is applied. This style guide varies depending on the type of the document.
Consistency is a cornerstone of any medical document. It can be easily lost when different members of a functional team are working on the numerous sections of multiple documents.
The review process
Drafts of regulatory or clinical documents are typically reviewed by a senior medical writer and a subject matter expert. As part of a QA checklist they will check the content by comparing the translation with the source data and suggest changes/corrections using a commenting track changes tool. The medical writer will then review the suggestions and either accept or reject them. Suggestions which raise debate are discussed during a review meeting.
Once all the queries have been resolved, the new version of the document will need to be checked again. When several documents with multiple appendices are created, this process can easily take several rounds of checks.
Formatting and editing
The style guide, template and approval requirements all come into play when formatting the document. The various considerations including font size, line and paragraph spacing, headers and footers, numbering, etc. must not be overlooked. It is, however, It is recommended to implement formatting requirements at the same time as the document is written as it would speed up the process at the editing stage.
Editing of the document is normally performed by another specialist to ensure there are no punctuation, grammar or style mistakes and that the QRD has been adhered to.
Approval and sign off
As a scientific document, it will now need to be approved by a designated expert. Adequate time should be allocated for this to ensure high quality of the final document.