Edit Checks (improved QuickEdit)

Our first release of TrialGrid introduced the Clinical Query Language (CQL). CQL allows you to write edit checks in an infix format (2 + 2 = 4) instead of the postfix format Medidata Rave uses ( 2 2 + 4 =). In our tests using CQL to build edit checks is much more efficient than the point-and-click alternative in Rave Architect and is easier to learn.

But what about Clinical Programmers with years of Rave study build experience? These users almost exclusively use the Rave QuickEdit format for edit checks and after years of practice think in postfix. What could we do for them?

Rave Architect has a very simple editor for QuickEdit, just a plain text area with check attributes, steps and actions all presented as pipe-separated lines. Despite its simplicity it provides a lot of power - allowing users to cut and paste check steps and actions and create new checks.

The TrialGrid equivalent editor has the same functionality and adds auto-complete features to allow the selection of action types, step types and folders / forms / field and custom function names:

The QuickEdit text can be cut and pasted between Rave and TrialGrid, making it very easy to take advantage of the advanced features of TrialGrid when in the edit/publish/test/edit cycle of working with edit checks.

The CQL format is still there and users can switch between the QuickEdit, CQL and Description tabs to see the check displayed in the format of their choice. Edits made to a check in the CQL tab are reflected in the QuickEdit tab and vice-versa.

Overall we think experienced QuickEdit users are going to feel right at home in the TrialGrid check editor.

QuickEdit for Derivations

Useful as QuickEdit is, Rave Architect doesn't offer a QuickEdit format for Derivations. TrialGrid now provides this with all the same auto-complete benefits.

This format can't be cut and pasted into Rave but it can still be a convenient format to edit Derivations if you are familiar with QuickEdit for Edit Checks.

Spreadsheet editing for Fields in Forms

The TrialGrid Form editor offers a lot of features:

• Drag and drop re-ordering of fields
• Form preview for Rave Classic and Rave EDC (formerly RaveX)
• Form preview by EDC Role (e.g. see a Form as a user with that Role would)
• Cloning Fields within the Form
• Copy and paste for View and Entry restrictions

These are all useful but nothing beats the convenience of editing an Architect Loader Spreadsheet (ALS) when you want to do bulk-changes to the Fields in a Form.

The downsides of spreadsheet editing are the need to import/export the ALS and taking care to make sure the changes are valid.

TrialGrid now allows customized grid-views of Form Fields to be defined per TrialGrid role. This means that you can define an editing grid for your Standards Management staff separate to your Study Builders or Data Managers. These views can include read-only columns, default values for new Fields and are especially useful when combined with Custom Field Properties (Field Metadata).

In the screenshot we see the Form editor with several custom sheets defined (Review Summary, Standards Review, Core Items) with the Standards Review tab selected. The selected column, "Standard Field Number" is a custom property added to Fields in the TrialGrid system. Note that this custom attribute has the same look and feel as the "normal" attributes of the Fields such as VariableOID, Field Name, Is Log etc.

Multiple editing grids can be defined for a TrialGrid role and each can have a different set of columns shown.

We think this grid editor provides the convenience of a spreadsheet with the validation and control of the normal Form editor.

Uppercasing Data Dictionary Values

The Data Dictionary editor in TrialGrid also uses a spreadsheet-like grid which allows cut and paste, sorting by column and drag-to-reorder but we recently the ability to uppercase text in selected cells:

This is a small feature, but very convenient when you need it.

Wrapping up

This is just a sample of the features added in the last few months. Look out for some future posts about enhancements to our document generation and automated test features!

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...

...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....

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:

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:

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

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!

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!