Review is the most crucial stage of document development, ensuring the quality and credibility of the final document. It is an integral part of the medical writing process and requires clear communication between the writer and the reviewer(s). There are two sides to this story. Miscommunication can make the review process frustrating for both the writer and the reviewer(s).
Thus, both parties must ensure that the review process runs smoothly and efficiently. The document development process is not about "us" versus "them," but about reaching a common goal within a clearly defined timeline: ensuring fit-for-purpose documents are submitted to health authorities, journals, etc., ideally resulting in authorization approval.
In order for a document to reach the target audience, it must undergo both content review and peer review. Prior to the document hitting the reviewers, the document must pass these three significant checks:
Internal review
QC Personal
Proofreading
INTERNAL REVIEW Managing and coordinating the internal review phase is a crucial part of medical writing. Before sharing the document with the client for their review, it must undergo content review and peer review internally. It is important for the medical writer to include the opinions of experts. A medical writer is responsible for ensuring that the document is error-free, including grammar, spelling, formats, citations, cross-references, and indexes. It is imperative that the final draft aligns with the client's style guide.
QC PERSONAL
An effective review always starts with a fresh eye, which is always beneficial to the document's quality. In the absence of a separate QC reviewer, the medical writer can perform QC themselves. In order to avoid conflict, it is possible to share the revised document with the QC specialist who reviewed the first draft.
Tools used to perform QC
Every organization has their own standards for producing documents (style guide, author-specific instructions etc.). SOP has detailed instructions available to follow while undertaking any document for review. SOP also supplement a checklist which is a live document and should be filled mentioning the concerns and other aspects of the document.
Software tools can speed up and greatly assist in the organisation and the conduct of document review; Usually, documents are distributed in Microsoft Word format and reviewed by using tools available in Microsoft Word. These review tools, e.g. tracked changes and comments are not only widespread and broadly accepted; they are also easily customizable with macros.
Creating checklist
Creating a checklist is based on the type of document and sharing it with the reviewer. Consider the formatting, style, correct use of grammar and punctuation, consistency of data, the main body of the document, conclusions etc. Use the resources available in ICMJE guidelines, AMA manual style guidelines etc.
PROOF-READING
Proofreading means checking errors in the draft carefully before it is published or shared. It's the last step in the writing process to make sure the document is error-free, including spelling, punctuation, and formatting mistakes. Proofreading is essential for any text that will be shared with an audience, whether it’s an academic paper, an online article, or a printable flyer. Editing can involve major changes to content, structure and language, but proofreading focuses only on minor errors and inconsistencies
Steps involved
Before proofreading, finalize the text
Take a small break, then read the document again
You can identify errors by printing your document and then reading it
Try to use an inbuilt application i.e. spell check or grammar check
Finally, take this document to the reviewer
Content editing | Revisions to an early draft of a text often involve significant changes in the content and the addition, deletion, or moving of entire sections. |
Line editing | Use language effectively to communicate your story, ideas, or arguments. |
Copy editing | The process of polishing individual sentences to ensure correct grammar, clear syntax, and consistency in style, often in accordance with a particular style guide. |
Proof reading | Misspellings, punctuation, and stylistic inconsistencies should be checked for any remaining errors. Additionally, proofreaders check the formatting (e.g. page numbers and line spacing). |
Summary
Review is a skill that can be taught and learned. As professional medical writers and communication experts, we should take the time to acquire this skill. Reviewers should be particular on how to provide clear, specific, constructive, actionable, and relevant comments, thereby helping each team member meet his/her full “reviewer potential”.
References
Trilogy Writing & Consulting GmbH. Help Reviewers Tell You What They Want - Trilogy Writing & Consulting GmbH. [online] Available at: <https://www.trilogywriting.com/publications/help-reviewers/> [Accessed 31 July 2022].
Schulz, K.F., Altman, D.G., Moher, D. et al. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med 8, 18 (2010). https://doi.org/10.1186/1741-7015-8-18
Icmje.org. n.d. [online] Available at: <http://www.icmje.org/recommendations/archives/2008_urm.pdf> [Accessed 31 July 2022].
McCombes, S., n.d. A quick guide to proofreading. [online] Scribbr. Available at: <https://www.scribbr.com/language-rules/what-is-proofreading/> [Accessed 31 July 2022].
Freyr - Global Regulatory Solutions and Services Company. n.d. Medical Writers Part 2: How to Handle Draft Preparation and Internal Review. [online] Available at: <https://www.freyrsolutions.com/blog/medical-writers-draft-preparation-internal-review> [Accessed 31 July 2022].
MS-MC-BL-22-7