Summer is usually a quiet time in our industry with people taking vacations but at TrialGrid we're busier than ever working with our clients to get the most from Medidata Rave and the TrialGrid application.

Medidata Webinar / Fix-All Diagnostics

The good news is we are continuing to make improvements and release new features. This month, in a joint Webinar with Medidata, we presented our Diagnostic "Fix All" functionality. This is particularly important to Medidata Rave customers as they adopt Rave 2018.1.0 or above. In these new versions of Rave, Medidata has taken a best practice (always set RecordPosition=0 for Standard Fields) and made it a requirement with the result that many ongoing Rave studies will need to be updated.

Long-term this change will be a great benefit to Rave users because not adhering to this best practice can cause edit checks to not work as expected - but in the short term it will be extra work. We know of one group that spent two
days of effort updating a single study. In the webinar we showcased our Diagnostic for RecordPosition and its automatic "Fix All" capability. Using this Diagnostic could have resolved this issue in 10 minutes - a saving of 15 hours and 50 minutes or 96% less effort.

Updates to CQL

Two years ago we introduced CQL, the Clinical Query Language, an alternative way of specifying Edit Checks. Rave Architect provides two ways of authoring Edit Checks: a point-and-click Edit Check builder and the powerful (but cryptic) QuickEdit text format. Both are based on postfix notation which can be difficult to learn. Here's a simple mathematical expression in postfix format:

2 2 + 4 =

CQL provides a more familiar infix notation:

2 + 2 = 4

Last week we upgraded our Edit Check editor with a new version of CQL and even better auto-complete helpers. This makes writing Edit Checks even faster.

Here's me starting an edit check. Notice how the editor offers me a listing of Folders or the Folder wildcard:

I choose the wildcard option (any folder) and now I'm choosing a Form:

I choose the AE form and now I'm choosing the Field:

Notice that TrialGrid is giving you much more here than just the Field OID that Rave requires for an Edit Check. We're also seeing the Field Label, whether it is a log Field, it's data type and any associated Data Dictionary. This extra context makes it much easier to select the correct Field without having to look up an annotate or have the Form editor open.

If I select a Field which has an associated dictionary and I ask for the CodedValue then typing a # gives me a listing of all the possible values from that Dictionary:

In each of these helper listings, typing a few more characters will filter the list of choices further. And this brings me to possibly my favorite feature of this upgraded editor, the Field search.

Field Search

Let's say you have the specification for a simple Edit Check:

AE Start Date cannot be later than AE End Date

You have to translate that into something you can create as an Edit Check:

AE Folder, AE Form, AESTDAT > AE Folder, AE Form, AEENDAT

Which means that you have to know the OID of the AE Folder and the AE Form and the Field OIDs for these Fields. In the new CQL editor you can simply type:

..End

To see a listing of all the Fields which contain (in their Question text or OID) the word "End":

Writing Edit Checks with CQL is fast, really fast but how does it compare to the Rave Edit Check point-and-click builder and to QuickEdit?

*Note that TrialGrid shows QuickEdit and CQL side-by-side and editing in one automatically updates the other so if you're productive with QuickEdit those skills are directly transferable to TrialGrid.

Medidata Rave is the market leading EDC system. The TrialGrid application is designed to help Study Builders make the most of Medidata Rave by speeding study development, managing library compliance and automating quality checks. If you want to see what TrialGrid can do for your team, Contact us

I started working with Medidata Rave in 2008 and I remember being impressed by the scope of the Rave product. Compared to other EDC systems it seemed to have everything: EDC, data migrations and versioning, double-key data entry, PDF generation, customizable workflow, non-programming edit checking, data export generation and reporting, library management, APIs for data import and export.. the list went on.

One thing that has always been missing however, is the ability to manage custom metadata alongside the metadata that Rave needs to function.

For example, Rave Forms have a number of attributes but in Architect there is no facility to add the SDTM domain or copyright information regarding the Form if it represents a validated instrument. Similarly, for the Fields in a Form there is no way to add additional metadata regarding the mapping of that Field to IxRS transfer specifications, SDTM generation or anything else, except by the use of naming conventions.

This omission has become more acutely felt as companies embrace the CDISC SDTM standard and work to make their study build processes repeatable. In order to plan a study from protocol design through to analysis many organizations have started to explore Metadata Repositories (MDR). These systems are designed to be highly configurable to different kinds of metadata and the mappings between them and to provide sophisticated tools for impact analysis and governance of that metadata.

MDRs promise much, but honestly I am yet to hear of an MDR project that was considered simple by anyone involved in it. They take time and a great deal of planning in order to deliver on their promise.

So what if you are an organization using Medidata Rave and you want to capture additional metadata on Rave Forms and Fields so that you can streamline your SDTM generation process? Chances are you are using a spreadsheet to capture that information and you have a process that looks like this:

This works but the mapping document and the study design can easily get out of sync, versioning is problematic and the Statistican has two Excel spreadsheets to merge and manage.

This is exactly the challenge our friends at BioForum faced when working with Medidata Rave. They have built a framework for the generation of SDTM from the Rave standard outputs which is driven by a mapping between Rave fields and Forms and the SDTM. Managing the mapping in the same tool where the Standard Libaries are maintained and where studies are built and quality checked would be so much more convenient:

To facililate this we built a simple mechanism into TrialGrid which allows users to define custom properties for their studies. These can be associated either with Form or with Field objects and users can decide whether to include these properties in object listings (e.g. to show the custom property alongside the Form OID in the list of Forms).

These properties then appear in the Form editor just like other attributes of the Form and Fields where changes to them are audit trailed.

These additional properties are exported from TrialGrid into the output ALS spreadsheet in their own custom sheets. You can load this file direct into Rave Architect since Architect ignores sheets it does not recognize. TrialGrid will load this metadata if it is present so if you do have an MDR and want to include additional metadata in the ALS file then TrialGrid can upload it.

Combined with our Library Management features, TrialGrid offers a simple way to manage compliance to library standards and an environment that unifies Rave study design and essential metadata management in a single solution which can be licensed on a per-study or per-user basis at a fraction of the cost of a full-blown MDR.

Please contact us for more information about the Standards and Metadata Management features of TrialGrid.

Matrices are a clever feature of Medidata Rave which define a set of Folders (which often represent Subject Visits) and Forms to be added to the Subject schedule. It's typical to have several Matrices which will be applied either by a user adding them manually or by logic defined in an Edit Check. Complex studies can have dozens of Matrices along with many Folders and Forms which can make managing them a challenge.

TrialGrid has a number of features which make working with Matrices a whole lot easier.

Selecting Folders/Forms

Our Matrix editor makes it really easy to see the intersection of Folders and Forms, something that is difficult in a large Matrix in Rave Architect where the Folder and Form headers can be scrolled off the screen.

Editing multiple Matrices at Once

Sometimes you need to make the same change to several Matrices. TrialGrid makes this easy with the multi-select option. Select the matrices you wish to change and then any Folder/Form you select (or de-select) is applied to all of those Matrices at once.

Creating All-Forms Matrices

It is very common to create a special Matrix which lists all the Forms defined in the Study. This is useful for proofing Form designs in PDF. Creating this kind of Matrix is easy but tedious. TrialGrid makes this a couple of clicks.

Creating Merged Matrices

Being able to see all unique Forms is useful but creating a Matrix which merges together all the settings from a set of other Matrices is more complicated. Unfortunately, this is commonly required to create a Matrix that can be used for printing full PDF records of subject data. TrialGrid makes this easier too:

to create...

Note that because Matrices don't define all Forms that can be added to the Subject Schedule a Merged Matrix may still need to be updated to add any Forms added via AddForm Edit Check actions or Custom Functions.

So there you have it, Matrix Mastery made easy! Contact us if you would like more information about this or any of the other time saving features of TrialGrid.