Batch Labelling

TrialGrid allows users to define Labels which can be used to signify workflow state of objects. Labels can be applied to all study design objects so, for example, you can create a label "Ready for Testing" and apply it to Edit Checks and to Derivations. Filters in object listings allow you to find all the objects which have a particular label.

Our last act of 2020 was to release new functionality which allows you to select a set of objects and apply (or remove) labels from them as a batch.

The ability to label objects in bulk is a great feature and the checkbox select on every row has already been used to make Form and Folder re-ordering more intuitive. Just check the rows you want to move and use the up/down buttons:

Improved Annotates

We have written before about our Microsoft-Word based document generation. This is a template driven system that can be used to generate all kinds of documents in Microsoft Word format. We provide some example templates and our latest Annotate template now calls out log sections as you can see in the example below.

There is a lot more we can do with Word document generation and a few weeks ago we also added PDF generation for customers who want the added security of PDF files. Contact us if you have a need to generate documents from Rave study designs. Whether its annotates, CRF completion guidelines, standard library documentation/usage guides, checklists, object level metrics or something else we can help.

Create URLs

CRO customers in particular will welcome the ability to create their own URL records in TrialGrid. CRO's routinely have Rave URLs which they share with a Sponsor and want a way in TrialGrid to mirror this arrangement. Users can now be assigned to have "Create URL" permission, copying setup such as Annotate Definitions, Labels and Core Configuration from existing URLs if needed.

Copy Project Metadata

Our first feature of 2021 is a simple way to copy Metadata between Projects. Similar to Labels, TrialGrid allows users to create new Custom Properties (or Metadata) for objects. This includes Projects and Drafts as well as Forms, Folders, Edit Checks, Data Dictionaries etc. For a Project you might use this Metadata to document what Therapeutic Area the Project study is targeting, the type of blinding, the study phase, whether it is a rollover study etc. Custom metadata can appear in project listings and in generated Annotates and it can also be used to drive Standards Compliance Rules (a topic for another day).

When you have many of these Project metadata values, creating a new project and setting all the values can be time-consuming. This feature makes it easier to copy these settings from an existing project.

Summary

We founded TrialGrid in 2016 to bring Medidata customers a better Rave Study build experience. Four years later we've expanded way beyond our initial ideas of Build Quality checks (currently 120 checks) and more intuitive Edit Check building into:

• Automated Testing of Edit Checks and Derivations
• Automated Form Data Entry
• Advanced editors for all Medidata Rave study build objects
• Study build Standards compliance checking and reporting
• Word and PDF document/annotate generation
• Team workflow and collaboration
• Study design visualization tools
• And a lot more

But the idea is the same: better tools for Rave Study build.

We have a lot more to do and most of our new features are driven by customers asking to do more with the TrialGrid system. Watch this space for developments or sign up for our newsletter at the top right of this page. Good luck with your Medidata Rave study build activities in 2021!

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!

One of the challenges of maintaining standard libraries in Rave Architect is that it is not possible to add any kind of notes or extended metadata on library objects. For example, a standard form might have the following information associated with it:

• A unique version number
• A description of the form and its intended usage
• Copyright holder and licensing information (e.g. for copyrighted scales)
• SDTM domain associated with the Form
• Rules regarding changes which are allowed to be made to the Form and still be standards compliant

Since Architect can't store this information it has to be maintained in some separate system. That might be a Metadata Repository (MDR), a set of modified Architect Loader Spreadsheets or in Word documents. However it is managed or presented, that metadata isn't available in Rave Architect where the study builder is doing their work.

So how does TrialGrid help?

Additional Properties for Forms and Fields

First of all, TrialGrid allows you to add additional metadata properties to Forms and to Fields.

Here we add a property "Field Set" to all fields:

And we do the same for the other properties we want:

• SDTM identifier for fields
• Instructions, Copyright, Version and SDTM Domain for Forms

Note that Version and SDTM Domain properties for Forms and Field Set properties for Field are marked as "show in lists". This tells the system to include this value in the Field and Form lists respectively.

Now that we have added these additional metadata properties we can now update these in our Form designer:

Now our Form listing contains the Version and SDTM Domain for that form:

We can also complete some property settings for Fields:

Note that for the Collection date we have entered a field set of COLLECTION_PLUS_AGE. In this form we should either be using COLLECTION_DATE and AGE fields or the Date of Birth Field. Later we'll use this custom property to display different sets of fields in different colors in our annotates.

Exporting and Importing Custom Properties

So far we've added custom properties to our Forms and Fields. This provides useful additional information to Study Builders inside the TrialGrid Form Editor. That's great if you're only using TrialGrid to manage your standards and to build studies - what if you want to load those custom properties into TrialGrid from an MDR export or want to feed the information captured in TrialGrid to other downstream processes?

TrialGrid provides this data as part of the Architect Loader Spreadsheet and can import and export this data:

It's simply added as an extra sheet in the ALS which Rave Architect will ignore.

Including Custom Properties in Annotate output

Part of the reason we add additional metadata to Forms and to Fields is so that we can communicate this additional information to other team members who may not be study builders. Including this metadata in an annotate is one good example, so lets do that.

Annotates are a new feature of TrialGrid, they allow you to define a template which can be used to generate a Microsoft Word document. We start with a simple annotate that just shows the basics about our Demographics form:

So far it contains none of the additional metadata which we just added. We'll need to edit the annotate template to do that. At the moment only TrialGrid employees can modify templates but I'm showing how it is done here because we expect that users will have the option to modify their own templates in future.

The format of annotate templates are very similar to HTML. Here we add a level 4 heading, grab the "Instructions" custom property and if it is defined (it may not have been set for all Forms) we insert the value into a paragraph before the layout:

We can add the Form version and Copyright properties to the table of standard Form properties using markup like this to add a row to a table:

that generates an annotate like:

Next we want to add the SDTM annotations. Typically these are done in color. We could choose any color for the background of these sections of text but lets go with aqua. Here we show how we add that text in that color to the field:

And we do something similar to the top of the form to add the SDTM domain there:

Lastly we want to highlight the rows of different Field groups to show those that should not be used together. The logic for this is reasonably complex but can be done within the template system in 8 lines. We need to look at every field and determine if it has a "Field Set" property set. For each unique "Field Set" value we assign a unique color from a list of colors we provide.

The result is:

The colors used here make it clear which groups of fields belong together. Note that this isn't a feature of TrialGrid, it's something we created ourselves with custom properties and some modification of our annotate generator - if you have a different system or different metadata you want to capture and show in annotates this can easily be achieved!

Summary

In this post we showed how..

1. Custom metadata (properties) can be defined in TrialGrid for Forms and Fields.
2. Properties can be edited in the Form editor
3. Property values appear in system listings such as the Form list
4. Properties can be imported and exported into/from the TrialGrid system using the Architect Loader Spreadsheet
5. Properties can be included in the new Annotate Templates system to document standards, usage instructions and key metadata such as SDTM annotations.

We're barely scratching the surface of what you can do with the annotate template system. Essentially it's a report writing engine that has access to all the data in an Architect Study Draft. That includes all the extra information that TrialGrid captures and that we haven't yet mentioned here - user comments on design objects, the audit trail of changes to objects, the standards compliance workflow state of an object, custom labels (such as workflow state) applied to an item and a whole lot more.

Contact us if you have particular needs for annotates or Draft reports. We can help!