Organising the review process in Microsoft Word<sup>®</sup>

Organising the review process

in Microsoft Word

Correspondence to:

Alexander Nürnberg

CRS Clinical Research Services

Mannheim GmbH, Richard-

Wagner-Strasse 20, 67269

Grünstadt, Germany

alexander.nuernberg@crs-group.de

Alexander Nürnberg

CRS Clinical Research Services Mannheim GmbH,

Grünstadt, Germany

Abstract

Regulatory documents are prepared in a highly col-

laborative process within tight timelines. The time

and the resources required for collecting input,

organising document review, and processing the

reviewers’ responses often dwarf those invested in

the actual writing. In our company, I have devel-

oped Microsoft Word

macros to manage and

document the review process. This solution, com-

bined with the modifications of the review work-

flow, is efficient and, as it relies on the features

already contained within Microsoft Word, does

not require additional software.

Keywords: Macros, Document review, Microsoft

Word

Review is the key process in document develop-

ment, which ensures the quality and the credibility

of the document.

It is also one of the most time-con-

suming steps for medical writers,

2,3

which has, if

poorly organised, a high potential for introducing

errors and inconsistencies into the document.

Software tools can speed up and greatly assist in

the organisation and the conduct of document

review;

yet, software solutions that meet the

medical writers’ expectations are remarkably scarce.

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 customi-

sable with macros. We, therefore, decided to adapt

them to our needs, aiming at a solution that:

• Is intuitively clear and does not need initial (or

worse, on-going) training;

• Promotes a strict separation between the review

itself and its implementation, with the

reviewers concentrating on the content and

the medical writers caring for the implemen-

tation, proper wording, and consistency check;

• Guides the reviewers through the document,

focusing them on relevant issues;

• Allows a parallel review and an unproblematic

consolidation of the reviewers’ responses;

• Provides a clear documentation of the review

process, discussions, and resulting decisions;

• Facilitates review organisation and processing

by the medical writers;

• Leaves the ultimate control over the document

in the hands of the medical writers.

Our solution consists of changes in the review pra c-

tice and the progr amming adaptations of the com-

menting functionality in Micr osoft Word, involving

rules for tagging comments and a set of macros.

Changes in review practice

We have abandoned the ‘track changes’ mode, which

is an excellent tool for indicating changes in a single

distributed copy, but is not practical if several

review ers are involv ed in the revie w. Instead, we dis-

tribute document copies that permit commenting

only and ask the review ers to provide their opinions

as comments in the document. This wa y, the

medical writer retains ownership of the document.

Upon review completion, comments from the

returned copies are automatically transferred into

the master document without producing conflicting

insertions and deletions. The resulting master docu-

ment containing all the comments represents a clear

record of the review process. This document can

then be conveniently processed by using dedicated

macros.

Tagging a comment

A comment in Microsoft Word conveys three major

pieces of information: the comment itself, the

author, and the scope (i.e. the marked text to

which the comment is attached). For an efficient pro-

cessing, we additionally specify the addressee, the

relevance, and the status of a comment by

DOI: 10.1179/2047480613Z.000000000166 Medical Writing 2014 VOL. 23 NO. 1

introducing standard descriptive phrases (tags) into

the comment’s body.

Addressee

The addressee of a comment is given by a boldfaced

upper case expression like ‘@SOMEBODY:’

(Figure 1A and B). By using this tag, we provide

guidance for the reviewers, denoting the comments

that need special attention. As the tags are in bold

uppercase, we reduce the risk of the comments or

the questions being missed. Unified abbreviations

implemented in the macro, e.g. @ALL,

@INVESTIGATOR, or @STAT, contribute addition-

ally to the clarity. In the end, this approach saves

the reviewers’ time, especially when the documents

contain numerous comments (a typical situation in

the early stages of document development).

Relevance

The relevance (in our parlance ‘rating’) is shown in the

first line of a comment as boldfaced ‘Ra ting:’ followed

by one of the fiv e categories (in descending order):

critical, major, minor, note, or editing (Figure 1B

and C). Assigning relevance to the comments and

the quest ions allows us to prioritise their processing

and to quantify document quality. In addition, we

introduced escalation rules, e.g. the critical comments

must be immediately clarified with the team, the

major comments need to be confirmed and follow ed

up, the minor comments requir e confirmation only

if declined, and the notes can be implemented or

rejected at the medical writer’s discretion.

Status

We specify the processing state of a comment by

assigning the ‘ status’ using four categories: done,

pending, declined (rejected), and confirmed

(Figure 1B and C). Similar to the rating, this tag

can be smoothly added or changed by a macro.

Replies

Although Microsoft Word provides functionality for

replying to a comment, such replies appear as

normal comments, with the only visible difference

being an ‘R’ added to the author’s initials (It has

been changed in the newest version, Microsoft

Word 2013, where the replies are displayed as a

discussion tree. Comments can be also marked as

‘done’ in this version.). Often, however, people

add replies as a new comment, sometimes at a

rather arbitrary location. In either case, the original

comment and several replies form a bewildering

array, which becomes even more disorganised if

several unrelated issues are discussed within one

page.

Our strategy is therefore to discuss each issue

within one comment, keeping the discussion

thread together. For this, we place a new reply

directly at the end of the initial comment and any

previous replies therein. Each reply starts with a

boldfaced expression ‘REPLY(Initials):’ (added auto-

matically) and is followed by the actual reply

(Figure 1B and C). Of note, our macro prevents

addition of the eighth reply, notifying the user that

a telephonic conference may be a better solution.

Managing comments

Although it is already a great improvement when a

comment clearly states what has to be done and who

has to do it, the full effect of these ideas is only seen

on a document-wide macro solution. Such a macro

analyses the comments within the document,

Figure 1: Examples of Microsoft Word comments in our format. (A) A comment addressed to a bioanalyst and a study

nurse during an internal review. (B) A comment from a sponsor that we rated as ‘critical’ and redirected to the bioanalyst.

The bioanalyst replied, declining the proposal. Hence, the status of the comment is ‘declined’. (C) A comment to the

statisticians during an internal review. There are two replies from the statisticians. Note that we set the user initials in

Microsoft Word to ‘company name/initials’ to distinguish in a better manner between the internal and the external

comments and to provide clarity for our customers.

Nürnberg – Organising the review process in Microsoft Word

14 Medical Writing 2014 VOL. 23 NO. 1

extracting information on the addressees, the

ratings, the status, and the replies. The extracted

information can be used in several ways.

Comments can be selected on the basis of their

tags (Figure 2). The macro allows a flexible combi-

nation of tags, e.g. selection of all the comments to

the investigator that are pending and critical, and

do not contain replies. The selected comments can

then be exported into a Microsoft Word or Excel

file, with the tags and the replies displayed in

separate columns (Figure 3). We use these lists

for documentation of the review process, for over-

views, for preparing telephonic conferences and

meetings, and as supportive documents for the

reviewers.

Alternatively, the comments can be selectively

deleted from the document. We routinely remove

unrelated comments from the distributed copies,

leaving the complete set of comments in the

master document only. This approach is especially

useful for an interim clarification of a single issue:

in this case, we can easily create an ad hoc copy of

the document that contains only issue-specific

comments.

Other applications of the macro include quality

metrics, with the overall number and relevance of

the comments being measures of document

quality, estimation of the remaining work load

using the status tag, and work allocation. The

macro can also control the proper implementation

of the reviewers’ comments, e.g. requiring that all

the declined comments are replied or that all the

critical and major comments are processed. Finally,

small and handy tools incorporated into the

macro, e.g. predefined replies or copy/paste of the

entire comment, provide go od assistance and

enhance productivity.

Summary

Certainly, the presented approach requires accus-

toming and some tuning of the review workflow,

but its benefits clearly stand out: document develop-

ment becomes more standardised and efficient.

Although we mostly use these tools internally

(external reviewers are invited but not required to

mark comments in our way), this approach has

been already accepted by several sponsors due to

its obvious benefits. Other companies also use

macro-assisted approaches in a similar manner

with a noticeable increase in the productivity and

the streamlining of the review process (Gwyn

Hopkins, personal communication). One macro of

particular interest in this context extends the

compare/combine functionality of Microsoft Word

to be able to combine the comments of several docu-

ments in one go, again demonstrating the power of

macro programming and its opportunities.

Figure 2: ‘Comments manager’ used for selection of comments on the basis of five attributes.

Nürnberg – Organising the review process in Microsoft Word

15Medical Writing 2014 VOL. 23 NO. 1

In conclusion, the author wants to encourage

medical writers to use macros in their daily work

and to invite them to discussions and exchange of

ideas. Macros are useful for a variety of tasks per-

formed by medical writers, saving time, resources,

and improving document quality. They can also

promote new ideas: forcing people to manually

add predefined text expressions in a specific

format most probably would have failed, whereas

the same ideas provided as easy-to-use menu

buttons were highly appreciated.

Acknowledgements

I thank Dr Gwyn Hopkins and Nadja Faißt for dis-

cussion and comments on the manuscript. I am also

grateful to all my colleagues who supported these

ideas. A special thanks goes to Anja Lerps,

Hannelore Putz-Gei ßler, and Tanja Knerr for

testing the macro and providing suggestions.

Conflicts of interest and disclaimers

The author is an employee of CRS Clinical Research

Services Mannheim GmbH. This is an independent

publication and is not affiliated with, nor has it been

authorised, sponsored, or otherwise approved by

Microsoft Corporation.

Permissions

The screenshot of Microsoft Word shown in Figure 2

is used with permission from Microsoft.

Supplementary material

Online supplementary material 1 of a demon-

stration file, containing the simplified macros

described above, is available.

References

1. Van Der Geest T, Van Gemert L. Review as a method

for improving professional texts. J Bus Tech Commun

1997;11(4):433–50.

2. Bernhardt SA. Improving document review practices

in pharmaceutical companies. J Bus Tech Commun

2003;17(4):439–73.

3. Cuppan GP, Bernhardt SA. Missed opportunities in the

review and revision of clinical study reports. J Bus Tech

Commun 2012;26(2):131–70.

Author information

Alexander Nürnberg is a medical writer at CRS Clinical

Research Services Mannheim GmbH.

Figure 3: An example of an exported comment. For clarity, the macro exports the whole paragraph surrounding the comment’s scope. The scope (i.e. the marked text to which the

comment is attached) is then automatically highlighted.

Nürnberg – Organising the review process in Microsoft Word

16 Medical Writing 2014 VOL. 23 NO. 1