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Library: Tips & Tricks

In the following, you will find a collection of tools, links, tips & tricks that we use and like to share with you. The topics are grouped in main sections; within each section there is a series of contributions set in ‚accordion‘ (expanding when you click on the item’s headline). Within a contribution you will find links either to other URL or to pdf’ed texts for download. This is a continuous project that will be updated regularly, also based on your feedback, comments and suggestions.

Tips & Tricks | MS OFFICE

Microsoft Office (MSO) still is the most frequently used tool for medical writing. MSO contains a wide variety of options, many of which are hardly known or used. This has two implications: i) not considering certain settings may cause problems and ii) learning to use certain options may make your writing work much easier. In the following we present a list of tips & tricks that might be useful. This list is growing steadily and will be updated regularly: therefore, keep posted!

Usually MSO-Winword written texts are subject to review by several parties and reviewers will highlight their comments and corrections by ‚Review-tracking‘. Setting changes to be tracked may inadvertently also update (without change) and therefore highlight within-text references and links upon saving the reviewed document e.g. Table-of-Contents, references to endnotes or footnotes, links to captions (Table or Figure Headings), etc. In this way, the tracked review document gets crowded with redundantly highlighted pseudo-updated links.

This can be easily avoided by having you and the reviewers make following change to the WINWORD-settings:
FILE | Options | Advanced | General | Web Options | Files | „Update Links on save“ ticked NO.

{21.Apr.2018 | ACPS-CdM}

When managing projects and trials you are likely to build up a vast collection of files. You should facilitate finding and sharing these files by setting and adopting strict rules on how to name files and how to set subdirectories to separate your files within the project’s main directory (e.g. administration | plan | application for approval | on-study trial documents, etc.).

Managing this structured collection of files becomes easier by setting a TOC in the root of the project’s main directory with all files linked and grouped by subdirectory. This also helps verifying whether your collection is complete and up-to-date. This can be done by creating a tabulated TOC with MSO-Excel. You can do this manually (which is rather tedious), but you can also do this ‚quick-&-simple‘ using the ‚IMPORT/EXPORT | Filename Lister‘ command in the Power Utility Pak Version 7 (PUP v7) add-in for Excel (download: ‚The Spreadsheet Page‚). This add-in contains several further tools and functions that makes working with MSO-Excel easier.

{21.Apr.2018 | ACPS-CdM}

Tips & Tricks | File Management Tools

There are many hurdles and challenges when trying to manage files and/or collections of files orderly and efficiently. Many providers offer services to sort this out, usually at high cost.
At ACPS we have found, tested and validated several tools that do the job reasonably well without being complicated or being expensive. We’re happy to share this with you. On the other hand: if you have a suggestion on how to improve/expand the list: give us a sign!

When managing projects and trials you are likely to build up a vast collection of files. You should facilitate finding and sharing these files by setting and adopting strict rules on how to name files. This may be tedious if you have collected files from a collaborating party who used other file name conventions.

You should solve such inconsistencies by renaming the files. This could be done manually, but would be tedious. A nice and easy-to-use tool for bulk renaming of files with a broad range of options is JOE Bulk Rename Utility (TGRMN) – Give it a look!

{21.Apr.2018 | ACPS-CdM}

When transmitting files to collaborating parties or authorities you should adopt a procedure that ensures (‚verifies‘) that the files received were not tempered with and are essentially the same as the files you sent out.

This could be done manually by reading out the files‘ HASH Checksums and by comparing these IDs between sender and recipient. When transmitting many files, this would be hardly possible while tedious. Possibly this is the reason why verification of file exchanges is rarely done.

ExactFile (download) is a nice and easy-to-use tool for two-sided verification of file transfers even if consisting of a complex collection of many files in several subdirectories – Give it a look!

{21.Apr.2018 | ACPS-CdM}

Tips & Tricks | Templates

Ishikawa diagrams (also called fishbone diagrams, herringbone diagrams, cause-and-effect diagrams, or Fishikawa) are causal diagrams created by Kaoru Ishikawa that show the causes of a specific event. Fishbone Diagrams are a nice way of visualising (primary | secondary) cause-effect relationships often used in quality management plans and reports; in this context they are often referred to as one of the one of the seven basic tools of quality control: The defect is shown as the fish’s head, facing to the right, with the causes extending to the left as fishbones; the ribs branch off the backbone for major causes, with sub-branches for root-causes, to as many levels as required.

In quality management of clinical trials they are relevant while mentioned in EMA/269011/2013 („Reflection paper on risk based quality management in clinical trials“ – Nov.2013): « The establishment of priorities will guide the analysis and evaluation of risks. Qualitative or quantitative process methodologies based on risk categories can be used. Well established methods, like fishbone diagrams or Failure Mode and Effects Analysis (FMEA), take into account likelihood of occurrence, impact, and detectability of risks and can be useful tools ».

There seems to be a misunderstanding here: such diagrams do not ‚analyse‘; if anything, they visualise the author’s analysis with the risk that the analysis is simplified in structure and wording such that it can be squeezed into such display.

Irrespective of these constraints, such displays are useful while looking ’nice‘ (‚professional‘?) and while following the lead of pertinent guidelines. Accordingly, they are worthwhile considering: useful templates can be found at template.net: 14+ Fishbone Diagram Templates – PDF, DOC. template.net also presents further templates that are useful for quality management plans & reports: 26+ Root Cause Analysis Templates10+ GAP Analysis Tools & Templates.

{ACPS-CdM | 05.Jun.2018}

Tips & Tricks | Medical Writing

High-level scientific journals are likely to check manuscripts submitted for publication of the results of clinical trials in terms of compliance with the so-called CONSORT-Guidelines. Also, the CONSORT initiative has launched recommendations (SPIRIT) on the content of trial protocols since it expects the protocol to be made accessible to the reviewer and reader of a result’s publication.

These guidelines have not been conceived and have only been partly adjusted to the content and format of early clinical development studies (phase I-II). Nevertheless, there are several items that you ought to pay attention to in order to avoid being CONSORT-downgraded. In the following we list the pertinent links to these rulings:

{21.Apr.2018 | ACPS-CdM}

English is the leading language in medical writing. In a collaborative global environment this often results in contributions with different English spellings depending on whether a contributor is based in the US or the UK. This doesn’t look ’nice‘. It helps if you can set rules upfront, but it is unlikely that all contributors will adhere. Therefore, you may left with a linguistic chimera that requires substantial editing.

To this purpose, it helps to know the differences and how to align them to one cohaesive either US- or UK-English version. In this regard we found help (and consolation) on WIKIPEDIA under ‚American and British English spelling differences

{21.Apr.2018 | ACPS-CdM}

In US-English, „two spaces after period“ are not uncommon. This „two-space“ rule was established during the days of typesetters, when additional space was needed to show the difference between the spacing between words (which was smaller) and the spacing between sentences (which was larger). When typewriters came around, they had only one font and all the letters were monospaced, or took up the same amount of space. People mimicked what they believed to be the format they’d grown used to by adopting two spaces after a period—and that’s how the so-called two-space rule was born.

Modern word processing programs not only offer a wide selection of fonts, but fonts are generally programmed to space characters proportionally. Also, most computer fonts will automatically give you enough room between sentences with just one space. Furthermore, „two spaces after period“ are really bizarre when you set your paragraph alignment ‚justified‘. In consequence, even in the US today the „two spaces after period“ rule is definitely out! Some nice readings on this topic can be found at: „How Many Spaces After a Period?“ by Brian A. Klems | „Sentence spacing“ at Wikipedia | „One space or two after a full stop?“ by Jacob Funnell, etc.

In a multi-national environment with strong US impact, you may still encounter „two spaces after period“ advocates and/or by copy-&-paste contributions, your collaborative texts may have both rulings.
You can sort this out by simply forcing the „one space after period“ rule: MSO-Word:
Edit | Replace | period-space-space > period-space | replace all. However, if your reader (client/sponsor) insists on keeping the „two spaces after period“ rule, then you may have to do the reverse (cautiously!).

Whatever the preference, we advise you also to adjust the related spelling check options:
File | Options | When correcting spelling and grammar in Word | Writing Style | Settings | Grammar Settings | Grammar and Style options | Spaces required between sentences > select: 1, 2, or don’t check.

{21.Apr.2018 | ACPS-CdM}