It seems you can never have enough Metadata. Last month I wrote about Custom Metadata for Projects and Drafts in the TrialGrid system and this week we expanded this capability further. You can now define Custom Properties for Forms, Fields, Projects and Drafts in the TrialGrid system and for each of those Properties define its display order, data type (text, boolean or choice) and list of allowed values.

Our industry is increasingly turning to Metadata Repositories (MDRs) to manage study design elements. Part of the promise of these systems is to capture not just the "What" of Forms, Fields, Data Dictionaries and other design elements but also the "Why" and the "How" : Why should this Field appear in this Form in this type of study? and How should the Form be modified if this is a Phase II rather than a Phase III study?

For all it's strengths, Medidata Rave Architect does not have any capability to import custom metadata. An MDR can output an Architect Loader Spreadsheet which defines the structure of the study but there's no way to include any of the data that led to that particular configuration. Examples include:

• Is this a follow-on study?
• What is the age group of the study participants?
• Is the study blinded, unblinded?
• What is the therapeutic area for this study?
• Will the study run in the USA / Europe / China / Japan?
• What Medical Coding system will be used for the study?
• Does the study use Rave Safety Gateway?
• Is there an ePRO component to the study?

Having this information associated as data to the study build is very useful to study builders in the short term but we have ambitions to use this metadata to automatically configure and validate study build. Watch this space!

When we started in 2016, Andrew and I had two main ideas for Medidata Rave: 1) Diagnostic Quality Checks and 2) Infix Edit Check editing. We didn't set out to create a better Architect but we needed a way for users to view and correct issues in study design objects identified by Diagnostics.

We introduced our Form Editor in early 2017 with some nice innovations for cloning Fields and moving them around, copying View and Entry restrictions and various other improvements over Architect:

Recently Andrew worked on further improvements and a few weeks ago these were made available on our Beta site.

Form Preview

We tried to make our Editor look a lot like the Form as it is displayed in Rave but our users were asking for improved preview and for Rave EDC (RaveX) preview. This is now available for Rave Classic:

And for Rave EDC (this one shown in full-width mode):

We're particularly excited about the RaveEDC preview since, at least at the time of writing, this is a capability that Rave Architect doesn't provide.

View and Entry Restrictions

Keeping track of View and Entry restrictions for Fields can be fiddly. In Architect and in our original Form editor these were separate lists but Andrew has now put them side-by-side which makes it a lot easier to see whether a user is View or Entry restricted to a Field. Really you only want one of these checked, if a user is View restricted (they can't see the Field) then they are implicitly Entry restricted!

In this screenshot you can also see an indication of the Form-level restrictions. Where a Field is restricted at the Form level there's no point in also restricting it at the Field level.

These changes to the editor also preserved the copy and paste functionality so if you have a block of Fields which should have the same restriction settings you can copy them from one Field to another. This can save you a lot of time and reduce errors.

Previewing Restrictions

The new Form Editor also offers the ability to preview as a particular role which makes it easy to check restrictions settings. Here I'm previewing a Form as the Batch Upload user and I can see that the first Field is View Restricted to me (it appears greyed out)

Summary

These are just the highlights of our new Form Editor. Andrew has also done a lot of work to improve the look and feel and the use of visual space to make designing and editing Forms in TrialGrid a really friction-free experience. We hope you'll like it and as always we want to hear new ideas for improvement of the TrialGrid system!

Medidata recently celebrated its 20 year anniversary, an amazing milestone, congratulations to all our friends and colleagues at Medidata!

Rave Architect, the Form and Edit Check design part of Rave, isn't quite 20 years old and in fact it still looks remarkably fresh, but nearly 20 years after it was first created, the needs of its users have grown. Some Rave installs have been running for more than a decade, accumulating hundreds of studies and reaching a scale that, I'm sure, would surprise the original designers of Architect.

That scale brings with it organizational challenges. Teams of 2 or 3 study builders in a single location have become departments of fifty or more study builders spread across different continents and timezones. Which projects are active? Which projects belong to which therapeutic areas? Which are the Phase III or Phase IV projects? Rave Architect doesn't have the ability to capture that Metadata. The Project listing in Architect gives you two useful attributes: The name of the Project and whether or not the Project is Active.

This isn't a criticism of Architect; It's a tool designed to help you with the work of building and publishing EDC studies. It isn't a project planning tool, a team coordination platform or a Metadata repository. As an organization that uses Architect you need to provide those things.

As a result Organizations have tools for Project planning, technical document management, specifications management, UAT findings tracking, programming review and many more - some of them use commercial software but many of them are home-grown using spreadsheets and shared drives.

Our goal at TrialGrid is to provide a single, integrated environment for the nuts-and-bolts work of the study build but also the tracking activities that go on around it. As every Clinical Programmer knows, the job isn't done when you create a Form or an Edit Check. You also need to update a system or a spreadsheet to indicate that you've done that work and that it's ready to be reviewed by a technical reviewer, a standards manager, a tester or a manager. Life would be so much easier if there was a function in the study build tool that would perform that step.

That's why in TrialGrid we provide Labels that can be applied to any study design object to signal a workflow state (e.g. Ready for Review) or to provide informational tags (e.g. IxRS Integration) and Custom Metadata that can be applied to Forms and Fields in the study design to capture additional information (e.g. Form Standards Version, SDTM Annotation, E2B field relation, SDV tier).

And this week we added the ability to apply labels and custom Metadata to Projects and to Drafts. Allowing you to get a better overview of your Projects and to filter or search the list:

Just like Labels and Metadata on other object types, you get to choose the names and colors of Labels and the additional Metadata you want to capture. If it's Metadata related to study design objects such as Forms, Fields or the Draft itself then it is automatically exported to and imported from ALS files. This is useful if your source of ALS files is not Rave Architect but some kind of Metadata Repository - now some of that useful Metadata can be transferred along with the study design where it's helpful for Clinical Programmers.

We have further plans for this kind of metadata. Stay tuned!

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