Diagnostics

TrialGrid Diagnostics are a set of automated checks that report findings, possible issues or recommended actions in a study design.

Medidata has a number of best practices for study build and teams usually also have their own in the form of study quality checklists. It is not uncommon to have a dozen or more checks that need to be made on a Medidata Rave study, usually by manual review of an Architect Loader Spreadsheet (ALS). Issues found during review may need to be documented along with any exceptions. Usually this check is performed once at the end of the study design or amendment process as a pre-release check.

Diagnostics automate these checks allowing a study designer to run them at any time at the click of a button.

Importance

Each Diagnostic has an Importance level of High, Medium or Low. By default all Diagnostics in the system are set to Medium importance. Depending on your use of Diagnostics you may wish to set certain diagnostics to be of High or Low importance. For example, Diagnostics related to Rave EDC may be of High importance if you are using Rave EDC but of Low importance if you are using Rave Classic.

Role Assignment

It is sometimes useful to be able to assign Diagnostic results to certain Project Roles. For example, results related to Custom Functions might be resolved by users with a different role to Diagnostic results for Forms and Fields. Each Diagnostic may be assigned to a Project Role. In the Diagnostic results users can then filter the results list to results which are relevant to their Role.

Additional Information

Diagnostics have a fixed description which cannot be changed by users. It is sometimes useful to be able to add additional information to expand this description. For example, to reference company standards or to provide further explanation and instruction. Additional Information can be set for each Diagnostic and will appear in the results and in PDF and Excel output.

Allow Fix

Some Diagnostics have Fix or Autofix options which allow a user with Fix Diagnostic Findings permission to apply a fix to the Diagnostic issue. This will change some attribute(s) of the study build such as a Check Step RecordPosition or the DataFormat of a Field. Allowing these fixes to be run can be switched on or off per Diagnostic so that a user who would normally have permission to apply a fix is not able to do so.

Copy from Another Project

To make it easier to ensure that the same set of Diagnostics, with the same settings, are run on different Projects the Import Settings feature allows Diagnostic settings to be copied from another Project (e.g. a Standard Library Project).

Diagnostics can be imported in one of two modes:

Overwrite

This setting discards all Diagnostics and their settings and replaces them with the Diagnostic settings from the Source Project.

Merge

This setting imports all Active Diagnostics from the Source Project along with their settings. Where these Diagnostics are also active in the Target Project, the Source settings will override (replace) the Target setting values for single-valued settings and will merge Source and Project settings on a line by line basis for multi-valued settings.

In this example the Exclude setting is multi-valued while the Max Length Diagnostic setting is single-valued. The example shows how the Merge option works for different Diagnostic settings and whether the Diagnostic is already active in the Target Project.

Diagnostic	Active In Source	Source Settings	Active in Target	Target Settings	Result Active	Result Settings
0001	Yes	Max Length = 10 Exclude = A B C	No	n/a	Yes	Max Length = 10 Exclude = A B C
0002	Yes	Max Length = 10 Exclude = A B C	Yes	Max Length = 20 Exclude = A B D	Yes	Max Length = 10 Exclude = A B C D
0003	No	n/a	Yes	Max Length = 20 Exclude = A B C	Yes	Max Length = 20 Exclude = A B C

Types of Diagnostic

TrialGrid provides a variety of standard Diagnostic covering SAS field naming compliance, recommended control types, spell checking, Clinical View Field and Form naming compliance and many more.

Diagnostic Catalog

Settings

Diagnostics may have associated settings which can be adjusted per-project. For example, text input Fields can either use the Text or LongText control type but the threshold for that decision might be > 50 characters for some Projects and > 40 characters for another. Diagnostic settings provide the capability to adjust these settings to your own project needs.

Some Diagnostic settings can use Regular Expressions.

Explanations

There are times when a Diagnostic will make a suggestion that is not appropriate in this particular case. For instance, that a Field would be better displayed as a set of radiobutton choices rather than a drop-down list. If the study design requires a drop-down list then this is an exception to the rule. TrialGrid allows these exceptions to be quickly documented so that they do not flag as findings in future runs of the Diagnostic for that Project.

When a Diagnostic has a number of results it can be convenient to make a single explanation for more than one of the results. TrialGrid allows result rows to be selected and then explained via a single dialog.

Addressing Findings

Some Diagnostics, for example the Spellcheck Diagnostic, offer the user the chance to address a finding by clicking the Fix button instead of entering an exception. This allows findings which require a change to be quickly addressed.

Reports

Every run of the Diagnostics generates a PDF report of the findings and exceptions that apply to those findings. The report is stamped with the name of the Project and Draft, the user that ran the Diagnostics and the date/time. This provides documented proof that the Diagnostics were executed.

Each run also generates an Excel spreadsheet version of the findings with a summary of the Diagnostic results.

Important

The Excel and PDF reports generated by running the Diagnostics reflect the results of that Diagnostic run. If users subsequently address findings, add or remove explanations for these results the reports are not updated. To get the latest state after making changes, run the Diagnostiocs again to generate new reports.