Articles tagged with 'TrialGrid'

New features in TrialGrid (February 2021)

Deleting Folders

One of the features of Rave Architect which can be frustrating for study builders is its enforcement of referential integrity. Simply stated, Architect wants to make sure that your study is always valid and that if, say, a Folder called "SCREENING" is referenced in an Edit Check, that a Folder called "SCREENING" does actually exist. This means it won't allow you to delete that Folder until that reference is removed.

Normally this is what you want but it can also feel constraining when you really want to delete that Folder but can't...

Folder in Use

...and as you can see, Architect doesn't tell you HOW the Folder is in use.

To be fair to Architect, it's trying to stop you doing something you will regret. If the Folder is referenced in 20 Edit Checks, removing that Folder will make those Edit Checks invalid and Architect won't let you save an invalid check so should it delete the related Edit Checks?

At times like these many Rave study builders will simply download the Architect Loader Spreadsheet to Excel - an environment that doesn't enforce referential integrity - and start doing search and replace and deletions. The danger of that is that you can waste a lot of time trying to re-load the study back into Architect when you don't get all the references matched up right again and you get caught in the edit -> try to load -> edit -> try to load cycle.

It would be nice if Architect warned you of the consequences of deleting the Folder and then allowed you to go ahead anyway. Kind of like TrialGrid does....

TrialGrid Folder in Use. Delete Anyway?

In this case TrialGrid is telling you what the consequences of deleting this Folder will be. You can then decide if that is really what you want to do.

Deleting checks and Derivations from the Form Editor

Following on from Folders it can be frustrating to find that you can't delete a Field from a Form because it has some related Edit Check. You could always see the Edit Checks related to a Field in the TrialGrid Form editor (just as you can in Rave Architect) but now the TrialGrid version allows you to delete those Edit Checks too:

Delete Field Related Checks

Draft Compare Report

Comparisons between Drafts are really easy in TrialGrid and we continue to make improvements in this area. In October 2020 we added popup compares but our users wanted a report they could export and share.

So now you can perform a compare and then export it to Excel:

Compare View

Every object difference is listed along with original and new values and a colored difference report of the changes between them:

Compare Report

This compare report makes it easier than ever to work out what changed between two Drafts and to share a report of those differences.

These are just a few of the convenience features in TrialGrid that help to make Study Builders more productive. Contact us if you'd like a demonstration of this or the many other features of TrialGrid!

New features in TrialGrid (January 2021)

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.

Bulk Object Labelling

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:

Form Reordering

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.

Improved Annotates

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.

Create URLs

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.

Copy Project Metadata

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!

CRF Completion Guidelines

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:

Help Display

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:

Rave Hosted Link

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

External Hosted Link

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:

Annotate with Help

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.

Public File

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.

Serving the File

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!