A number of logical steps are supposed to be followed when we consider writing scientific documents, especially documents that are required by pharmaceutical companies (sponsors) for submission to regulatory agencies such as the US FDA, EMEA, MHRA, DCGI etc.
1. Understand your assignment well:
Writing a document is going to become much easier and less time consuming when the writer knows its importance, where it is going to be used and what for. Hence, invest a reasonable amount of time in knowing more about the document if you are not already familiar with it. Also, understand how much data is required to be studied, where it is available and any sponsor specific document review and approval processes that you need to follow.
2. Conducting a literature search:
Even before you start writing the document spend a considerable amount of time in identifying useful valid resources that you can refer to and use to support your document. Conducting a thorough literature search may provide some very useful information which you must properly categorize for future use.
3. Authoring & Compiling:
Writers usually spend most of their time in writing the first version of the draft document. As mentioned earlier, if you have previously spent time in understanding your project well, writing the first version will be less time consuming. It is also useful to find any pre-defined templates if available for the document that you are writing. This will again serve as a model for you to build your work on and will reduce the writing time. Also, follow the required style guides and any sponsor instructions in your first draft. This will significantly reduce revision and document finalization times once the first draft is complete. Should the document contain any appendices, inform the sponsor to provide you the same and as a medical and scientific writer, it is your responsibility to ensure that a document complete will all required appendices is provided to the sponsor.
4. Review:
Review of the core content of the document and of the editorial/formatting are the two important aspects in the review process for any scientific documentation. Review of contents is usually performed by an experienced medical writer with vast experience who is also a subject matter expert. Quality check (QC) of contents should be performed by a peer medical writer through cross-checking the verifiable information with that of the available source of data. It is recommended that you do a thorough “self check” of the first draft of the document before sending it for a peer review.
5. Editing & Formatting:
Any medical writer who wants his work to be respected must learn the art of editing and formatting scientific documents. Proper formatting and editing makes any document more presentable and acceptable in the scientific community. While editing refers to checking the document for the correct use of grammar, tense, punctuation marks, referencing style etc, formatting is the use of correct word font, style, line spacing, header, footer, page numbers and margins. For publication or electronic publishing of your document, copy-editing, proof-reading and checking the formatting requirements are mandatory.
6. Document approval and Sign-off:
Once the first version of the document is ready including the completion of editing and formatting it must be sent to the authorized internal or external approver as applicable. You must provide the approver sufficient time to read the document before it can be approved by signing-off the document.
7. Electronic Publishing:
With the increasing use of the internet and as our lives continue to become more and more digital, it is critical that the modern day medical writer is aware of e-publishing options and the importance of making the document available in a digital format for online access by users. Many software’s are now available that make e-publishing an easy task and you must put in an effort to make yourself familiar with their use.