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.

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. Diagnostics are split into several categories.

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.

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.