What are CRF Completion guidelines?

When a clinical site is recruited to participate in a clinical trial it is common to provide CRF Completion Guidelines - a document which describes the particular data collection requirements for the study. For a study using Medidata Rave this might include guidance on how to log into Rave and navigate the system to perform particular tasks. Typically the guide will be study-specific to familiarize clinical site personnel with key data collection forms and requirements of the protocol.

Support in Medidata Rave

Medidata Rave has a few features which help study builders develop and distribute CRF Completion Guidelines.

First, Rave has an Annotate (or blank Forms) option in its PDF generator which can be useful for generating a visual representation of the forms. Unfortunately the generator does not have an option to include help text entered for forms and fields built into the study design and help text is key information for guidelines. The generator also only outputs PDF files which limits its flexibility because editing PDF files requires special software. The Rave PDF generator can still be a useful starting point and some organizations use it as the basis for their guidelines - adding back the help text and inserting additional pages of information.

The second useful feature is the Rave eCRF itself. Help text entered for forms and fields can be displayed by clicking the help icon next to a field:

But Rave has another trick. The Field and Form help can be turned into a hyperlink that loads another web page or a document in a new window. By prefixing the help text with %% (two percent signs) you can make the help text link a link to a file hosted by Rave:

Or to a file or webpage hosted on some other system.

Here we just link to the Google search page but it could be a link to a document to be loaded in the browser.

Support from Medidata

This feature of Rave makes it easy to create a link from field or form help in Rave to a CRF Completion Guidelines file in PDF format. Clicking the link will open the Guidelines in a new browser window.

There isn't a self-service option in Rave for loading CRF Completion Guidelines (or any other type of file) but customers can request Medidata to load files into their Rave instance for them. This is a good option for study build teams which don't have IT support for hosting files but it does not provide the team with much control for updating the Guidelines.

Since you can host these files externally there are many other options. You could use a general file hosting service such as Dropbox but often there are restrictions on the services which a study team can use.

How TrialGrid can help

TrialGrid provides several features that can help study teams with their CRF completion guidelines.

First, our document generation system can generate Microsoft Word as well as PDF documents. Word is a great basis for CRF Completion guidelines because it's easy to insert additional content. Here is a simple example showing form and field help using a document template we developed for a customer. This page was completely generated by our document generator:

Secondly, TrialGrid projects have a files area where study teams can upload files related to their project. Normally these files are private, only team members can download or view them but last month we added a new feature that allows these files to be made public. A file that has been made public can be viewed by anyone with the link.

Pressing that copy-link button gives you a link you can give to anyone to share the file. This is especially useful for Form level help in Medidata Rave. Pasting this URL into the Form help preceded by %% means that when published anyone clicking the help button in Rave will open the file from TrialGrid without needing a TrialGrid login. An example file name might be:

%%https://beta.trialgrid.io/public/TEST_STUDY/FIXYA/CompletionGuidelines/FIXYA_CRF_Guidelines.pdf

Note that users with this link can't see any other content in TrialGrid.

The benefit of using TrialGrid to host CRF Completion Guidelines in this way is that the TrialGrid Files area is controlled by permissions so only users with rights to modify files and permission to make files public can change them. It is also completely self-service, allowing the team to easily change the guidelines just by switching the file in the TrialGrid system without changing anything in the Rave study design.

Summary

CRF Completion Guidelines are an important support to sites but creating them and making them available online can be a challenge. In this article we showed how to use the HelpText %% feature of Rave to link to Guidelines hosted by Medidata Rave or by other systems. We also discussed the features available in Rave for creating and hosting CRF Completion Guidelines and the features in TrialGrid that support these activities.

If you are interested in better ways to generate and host CRF Completion Guidelines for Medidata Rave studies please get in touch!

The case of the missing characters

Last week a customer reported that we had a bug in our comparison view. Their Custom Functions were showing changes between their library drafts and their study build drafts. Here's an example screenshot. Removed characters are shown in red and characters added are shown in green.

It looked like some spaces were being removed and replaced by a single space.

Looking at the Custom Function in the library it was apparent that it contained a Tab Character. A tab character doesn't have a defined width, it can be represented as one or more spaces. In our Custom Function editor it showed as 4 spaces:

But how had it got there and why was it present in the library but not in the Study Draft?

Tabs in Architect?

An investigation of Rave Architect showed that it was possible to get Tab characters (also known as CHR(9) or \t) into a Custom Function in Architect if (and only if) you paste the code from some other editor. Pressing the TAB key in the Rave Custom Function editor just moves you out of the code editor area so you have to do this with cut and paste.

This tab character has no real effect in Rave Architect, it's just whitespace like a space character but a tab character isn't a space so the TrialGrid compare was showing a difference.

Now we knew that it was possible for a tab character to come from Rave Architect we had an idea why it was in the library draft. But why was it missing in the Study Draft?

ALS files have accents

Architect Loader Spreadsheets (ALS) files are stored in Microsoft Excel 2003-2004 XML format. This is not the same as the .xslx format which is new the Excel default format. The 2003-2004 format stores the sheets and rows in a single XML document and the way the contents are formatted gives you a clue as to what created it. An file exported from Rave Architect looks like this:

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<?xml version="1.0" encoding="UTF-8"?>
<?mso-application progid="Excel.Sheet"?>
<Workbook xmlns="urn:schemas-microsoft-com:office:spreadsheet" xmlns:ss="...">
<Worksheet ss:Name="Sheet1">
<Table>
<Row>
<Cell>
<Data ss:Type="String">Cell Data 1</Data>
</Cell>
</Row>
</Table>
</Worksheet>
</Workbook> 

while a file saved by Excel looks like this:

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<?xml version="1.0" encoding="UTF-8"?>
<?mso-application progid="Excel.Sheet"?>
<Workbook xmlns="urn:schemas-microsoft-com:office:spreadsheet" xmlns:ss="...">
 <Worksheet ss:Name="Sheet1">
  <Table>
   <Row>
    <Cell>
     <Data ss:Type="String">Cell Data 1</Data>
    </Cell>
   </Row>
  </Table>
 </Worksheet>
</Workbook> 

Despite the distinctive formatting differences, these two examples store the exact same data.

Importantly, the Draft where the Tabs had been switched for spaces had the Excel style formatting so we knew it had been modified in Excel before being uploaded to TrialGrid.

Conclusion: Excel eats Tab Characters

Once the finger was pointed at Excel it didn't take long to discover that Excel swaps tab characters for single spaces on save. This was the cause of the characters switching from Tabs to Spaces.

As a result of this finding, we have switched TrialGrid to replace tabs with spaces in Custom Functions. This makes all our comparisons consistent regardless of whether the Draft was loaded direct from Rave or was modified in Excel first.

In our last post I showed the popup compares feature which released in October but it wasn't the only new feature in October. We also released:

• Draft Cloning
• Draft Locking
• Draft Approvals
• Built-in training videos

Draft Cloning

One of the great features of Rave Architect is the ability to make a copy of a Draft and all its Forms, Edit Checks and other design objects.

Now TrialGrid has this feature too!

TrialGrid users get the additional benefit of copying all the Labels and Custom Properties assigned to those design elements. Custom properties can now be defined for Edit Checks, Derivations, Unit Dictionaries, Custom Functions, Matrices, Data Dictionaries and Folders as well as the original Forms, Fields and Drafts.

Draft Locking

TrialGrid maintains an audit trail of changes made to your study drafts and libraries but when you want to make absolutely sure that no changes are made to your Draft or Library you want to Lock it.

Users with permission to lock a Draft can ensure that no changes are made to the Draft unless it is unlocked. Locked Drafts appear with a padlock icon in the breadcrumbs and in listings as shown:

Draft Approvals

Besides locking a Draft against changes you may also need to get approval from other team members for the Draft design. Now Project Roles have a permission to determine if they can approve a Draft. Like Locking, the approval of a Draft shows in the Draft properties area and also as an action in the audit trail:

Training Videos built into the TrialGrid application

The TrialGrid system contains a lot of online help but sometimes a short video introduction to a feature is all you need to refresh your memory on the training. During September and October we have been recording a number of short videos and embedding them in the TrialGrid system. In the TrialGrid header look for the Training video symbol:

Clicking the video icon brings up the training video:

We think these short training videos a great way to provide targeted refresher training to new and existing users. What do you think?