Organise the comments so that they can be processed
When several reviewers comment on one document, their comments have to be collected, sorted, routed and processed before anyone resolves them. A review arrangement has to do this job, and one worked system does it with tags and macros built out of the word processor's own commenting function.
What a review arrangement has to do
Review is one of the most time-consuming steps for medical writers, and if poorly organised it has a high potential for introducing errors and inconsistencies into the document. Software tools can speed up and greatly assist the organisation and conduct of review, yet in 2014 software solutions that met medical writers' expectations were remarkably scarce. Documents are usually distributed in Microsoft Word format and reviewed with Word's own tools, such as tracked changes and comments, which are widespread, broadly accepted and easily customisable with macros. For regulatory documents, the time and resources spent collecting input, organising review and processing reviewers' responses often dwarf those invested in the writing itself. A system for organising review can be built from the word processor's commenting function and a set of macros, and it then needs no software beyond the word processor.
Such a system was designed to meet seven goals: it should be intuitively clear and need no initial or ongoing training; it should promote a strict separation between the review and its implementation, with reviewers concentrating on content while the writer handles implementation, proper wording and the consistency check; it should guide reviewers through the document and focus them on relevant issues; it should allow parallel review and unproblematic consolidation of the responses; it should document the review, the discussions and the resulting decisions; it should make organisation and processing easier for the writer; and it should leave ultimate control of the document in the writer's hands.
Comments rather than tracked changes
Tracked changes are an excellent tool for indicating changes in a single circulated copy, but they are not practical once several reviewers are involved. So the system distributes copies that permit commenting only and asks reviewers to give their opinions as comments, so that the writer retains ownership of the document. On completion, the comments from the returned copies are transferred automatically into the master document without producing conflicting insertions and deletions, and the master document is then a clear record of the review.
Addressee, rating and status tags
A comment in the word processor natively conveys three major pieces of information: its text, its author, and the scope of text it is attached to. For efficient processing, the system adds three more, the addressee, the rating and the status, as standard descriptive phrases inside the comment body.
The addressee is a boldfaced upper-case expression of the form @SOMEBODY:, drawn from a unified set of abbreviations implemented in the macro, such as @ALL, @INVESTIGATOR or @STAT. It points reviewers to the comments that need special attention. The bold upper case reduces the risk of a comment or question being missed, and the unified abbreviations add to the clarity. The approach saves reviewers' time, especially when a document carries numerous comments, as documents typically do in the early stages of their development.
The rating states relevance in the comment's first line as one of five categories, in descending order: critical, major, minor, note and editing. It allows processing to be prioritised and document quality to be quantified, and it carries escalation rules, for example that a critical comment must be clarified with the team immediately, a major comment must be confirmed and followed up, a minor comment needs confirmation only if it is declined, and a note may be implemented or rejected at the writer's discretion.
The status records the processing state in four categories: done, pending, declined and confirmed. Like the rating, it can be added or changed by a macro. In one worked example, a sponsor's comment was rated critical and redirected to the bioanalyst, who replied declining the proposal, so the comment's status became declined.
The recorded author can carry more as well. Setting the word processor's user initials to the company name plus the person's initials distinguishes internal from external comments more clearly and gives the client clarity.
Replies within one comment
Replies can leave comments disorganised. In Word versions before Word 2013, a reply appears as an ordinary comment, distinguished only by an "R" added to the author's initials, and people often add replies as new comments instead, sometimes at a rather arbitrary position. Either way, the original comment and its replies form a bewildering array, and it becomes more disorganised still where several unrelated issues are discussed within one page. So each issue is discussed inside one comment, keeping the discussion thread together: a reply is placed at the end of the initial comment and any earlier replies, and it opens with a boldfaced REPLY(Initials): that is added automatically. The macro also prevents an eighth reply and tells the user that a telephone conference may be a better solution.
What the tagging buys
A comment that clearly states what has to be done and who has to do it is already a great improvement, but the full effect of the tagging is seen only with a document-wide macro. Such a macro extracts the addressee, rating, status and replies from the comments in the document, and the extracted information can be used in several ways.
The macro selects comments by a flexible combination of tags, such as every pending critical comment addressed to the investigator that carries no reply, and exports the selection to a word-processor or spreadsheet file with the tags and replies in separate columns. These lists serve as documentation of the review, as overviews, as preparation for meetings and telephone conferences, and as supporting documents for reviewers. The macro also deletes comments selectively, so that circulated copies routinely carry no unrelated comments while the master keeps the full set, and an ad hoc copy made to clarify one interim issue carries only the comments on that issue. It supplies quality metrics, with the overall number and relevance of comments as measures of document quality, it estimates the remaining workload from the status tags, and it supports work allocation. It can check implementation, requiring for example that every declined comment has been replied to and that every critical and major comment has been processed. Small tools built into it, such as predefined replies and copying a whole comment, provide good assistance and enhance productivity.
What it costs to adopt
The approach requires accustoming and some tuning of the review workflow, and its developer reports that in return document development becomes more standardised and efficient. The tools are used mostly internally: external reviewers are invited to mark their comments the same way but not required to, and several sponsors have accepted the approach. Other companies are reported to use macro-assisted approaches in a similar way, with a noticeable increase in productivity and a more streamlined review process. One macro of particular interest extends the word processor's compare-and-combine function so that the comments of several documents can be combined in one go.
The same developer judges that forcing people to add predefined text expressions in a specific format by hand would most probably have failed, whereas the same ideas offered as easy-to-use menu buttons were highly appreciated.