One of the changes in the next Medidata Rave release, Rave 2018.1.0, is that standard fields in Edit Checks must have a Record Position of 0. This has long been a recommended best practice but up till now has not been required. Rave will now check that the Record Position is correct when saving an edit check in Architect, when uploading an Architect Loader spreadsheet and when publishing a Draft. If you try to publish a Draft with invalid Record Positions you'll see this error message:

There is a good reason for enforcing this rule - it means that there will be no confusion between standard fields and log fields when executing the Edit Check. But if you have existing studies or libraries it may take hours of work for each Draft to locate and update Edit Checks. Unless you're using TrialGrid!

TrialGrid's Diagnostic 0027 analyses all Edit Checks and Derivations, quickly showing you which ones need to be updated:

and then updating them is as simple as clicking the 'Fix' button. In minutes you can have reviewed and corrected them all!

Diagnostic 0027 is one of the 79 Diagnostics available now to all existing TrialGrid users. We have Diagnostics to help with other upcoming changes in Rave 2018.1.0 and with upgrading to RaveX. As and when Medidata introduce new features and enhancements in Rave Architect, we ensure that TrialGrid is up to date and compatible with the latest changes, and look for ways we can help with upgrades.

Contact us if you would like a demo or to know more.

As a Rave Study Designer you have limited options for visualizing a study design, especially a complex one. You can publish the study to a test environment and browse through the Folders and Forms but this is a view intended for users, not for Architects. As a Study Designer you want to be able to see Folder, Form and Field identifiers and see where Edit Checks are associated with Fields.

If you had the time you might take a large pin-board and recreate the Matrix design with index cards. Use an index card for each Folder in a Matrix and beneath each Folder add another index card for each Form which appears in that Matrix. Like this:

That's helpful but it would be even better if we could see all the Fields on each of the Forms. If we were to write those onto the Form index cards it would look like this:

That kind of view is really useful for planning and reviewing Edit Checks since you can see all the identifiers of the Fields. It provides a view that makes sense to both Clinical Programmers and Data Managers, a shared way of thinking about the Study that makes it easier to collaborate on the design.

Now if you wanted to visualize how Edit Checks relate to the Folders, Forms and Fields you could use an index card for each Edit Check and pins with string to connect the Edit Check index cards to the Fields they reference.

Doing all that would be a lot of work, take a lot of wall space, use many metres of string and a lot of index cards but it would give you exactly the kind of view you need as a Study Designer or Data Manager to understand your study structure and Edit Check coverage. Even zoomed out you can see Fields which do not have any associated Edit Checks - they are the ones with no blue-dot connectors beside them.

TrialGrid Matrix Explorer

Before you start raiding the stationary cupboard, consider taking a look at the TrialGrid Matrix Explorer. It does all of this for you and more:

• Pan and Zoom of the image so you can get a high level view or dive down into the detail
• Filter by Form
• Filter by Field type (e.g. show only Date/Time Fields)
• Filter by Form-only Edit Checks or by Cross-Form edit checks
• Filter by Edit Check action type (e.g. just OpenQuery or AddForm Checks)
• Navigate direct to Form / Field / Edit Check editor from the diagram
• Hover over Edit Check to see definition and actions for that Edit Check
• Hover over Field to highlight all related Edit Checks for that Field

The Matrix Explorer is available now to all existing TrialGrid users with Study Build access. Contact us if you would like a demo or to know more.

One of the features we have frequently been asked for is a way to compare Drafts so we're delighted to release Draft comparison capability to our Beta site this week.

Medidata Rave already has an Architect Difference Report but it cannot be used to compare two arbitrary Drafts so if two team members make duplicate Draft copies of the current Version and then make changes to those Drafts it is not easy to see what the differences between these two Drafts are:

In addition, the Difference Report is presented as an Architect Loader Spreadsheet which takes some experience to interpret. In the below example the name of the DM Form was changed:

We can see in the Source (S:) the name was "Demographics" and in the Target (T:) the name has been changed to "Demography"

In fact the changes go deeper than that. In the Fields tab we can find further changes to the DM Form:

The RELSTAT field does not appear in the latest version (the source) but does appear in the target Draft.

So the Difference Report is a useful tool for certain types of Draft comparison but is quite heavyweight.

Comparing Drafts in TrialGrid

When we make the same changes in copies of these Drafts in TrialGrid and then compare Original to New we first see a summary which shows not only what changed but when it was last changed and by whom:

We can then explore the changes further via the Compare button on each changed object:

Changing Ordinals

One complication of comparing Drafts is that adding or removing a Form or Folder causes the renumbering of the Ordinals of those objects - which would then appear as a change. The TrialGrid Draft Compare handles this by detecting if the only change was the Ordinal and reporting if that is the case. Here I re-ordered some Forms so that their Ordinals changed:

In Source not Target, in Target not Source

Finally, in the case where Objects appear in one Draft but not in the other TrialGrid also reports that:

Wrapping up

The Architect Difference Report is a tool which many Study Builders rely on to determine what has changed between a working Draft and the current published Version of the study design. TrialGrid augments this capability by providing a convenient way to compare any two Drafts (even across Projects).

If you think that might help your team, get in touch!