Managing A Multi-Stakeholder Writing Project

Research and development in the pharma and medical device industries involve many stakeholders (e.g., regulatory affairs, clinical, biometrics, clinical pharmacology, CMC, non-clinical), and thus a regulatory document almost always has multiple authors. Writing a regulatory document with multiple collaborators can be chaotic and time-consuming. Adopting a few of the principles underlying document writing operating procedures used by pharmaceutical companies and clinical research organizations that specialize in medical writing can simplify and expedite the process.

The best practice is a process initiation meeting during which several decisions can be made:

·??????First, the document’s "owner" must be determined. This author can be, but does not have to be, the medical writer. The meaning of document ownership is that the author is responsible for coordinating the writing and review activities of the various stakeholders within the group as well as for external activities such as quality control (QC) and publishing, and submission to the regulatory authorities.

·??????The process for input resolution should be decided upon. For the most part, there should be one or more comment resolution meetings built into the timeline. In addition, there should be a stakeholder who has the authority to make the final decision on the content of the document or on specific sections of the document (e.g., the Safety Physician who has the final say on safety sections across submission documents).

·??????After choosing the document owner, areas of responsibility need to be defined. Who shall be responsible for writing each section? Sometimes, sections can be lifted as they are from source documents, but in other cases de novo text is needed. The responsibility for formulating messages and ensuring their consistency across the program documents is especially important and should be discussed in the kick-off meeting.

·??????Finally, the hardest part is making the decisions pertaining to the work process. Whenever possible, it is advisable to design a timeline comprising a series of meetings (discussion of results, comment resolution, etc.). It is important to know what the preferred mode of communication is for the group and for each collaborator, and what is the best way to communicate with them in order to receive rapid responses. A convenient solution worth considering is storage of data (including drafts) in an online repository accessible by everyone in the group. It is very important to try to get the co-authors (or at least some of them) to commit to timelines of reading and reviewing the drafts. In this context, advance knowledge of any prolonged absences of the co-authors is important and useful. In terms of the process, it is useful to hold rounds of review and revision sequentially, so that each contributor is able to see the input provided by his/her predecessors and the article owner does not have to consolidate the comments of various reviewers. For the sake of this process, it is best when notes are provided in "track changes" mode, with the reviewer's identity and time of review. If the timeline does not allow such sequential reviewing, it is best to conduct concurrent reviews on collaboration platforms such as Veeva Vault or Please Review.