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!

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!

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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