Using Diagnostics to Improve your Study Design

One of the main functions of TrialGrid is to identify issues in a Medidata Rave study build before it goes to production since corrective migrations are time consuming and costly to manage. TrialGrid Diagnostics automate best practice guidelines to provide assurance that these guidelines have been considered and applied where applicable. But beyond ensuring a minimum level of quality, Diagnostics can also help a Study Team determine if their edit check coverage is adequate.

A recent Diagnostic we developed, 0068 : Date Fields should have at least one Edit Check that creates a query examines the study design looking for Date Fields on Forms which do not have any associated Edit Checks which would raise a query on that Field. This is an indicator that this Field is not being compared to other dates in the study and that an additional Edit Check might be a good idea. For example, if a date of a test does not have an Edit Check that compares it to another date then any date would be valid which is not intended.

Performing this kind of check manually is certainly possible but it is time-consuming and error prone. The easiest way, besides using TrialGrid or writing your own tooling to perform this check, is to:

  1. Download the Architect Loader Spreadsheet
  2. Filter the DataFormat column to only DataFormats containing "y" (a year component). Date/Time fields in Rave can be used to collect just a time component so we want only those dates that actually capture a year.
  3. Filter the Field list to just Visible and Active Fields since checking on inactive or invisible Field isn't really meaningful.
  4. Check that Fields are not present on Inactive Forms. A review of the Forms sheet of the spreadsheet can help us determine that.
  5. Filter the CheckActions sheet of the spreadsheet looking for the VariableOID of our candidate Fields
  6. Filter the CheckActions for just the OpenQuery check action.
  7. Check that the Edit Check is active by review the Active column in the Checks worksheet
  8. Review the Derivations sheet to ensure that this Field is not being derived. It makes no sense to raise a query on a derived date Field.

The list of Fields you are left with are all candidates for additional edit checks.

The steps to perform this check manually are not complicated but they do require switching between different worksheets of the spreadsheet. It's time-consuming work and not very rewarding for the Study Builder so organizations may choose to take a risk-based approach and perform this level of check only infrequently.

Alternatively you can eliminate the risk and the drudgery by using TrialGrid to automate these kinds of quality and conformance checks for your Study Builders and free them up to do more valuable work.