Standard Libraries

TrialGrid manages Standard Libraries in a hierarchy of linked Drafts:

Library Structure

A Standards Library is simply a Draft inside a Project which has the “Is Standards Library” checkbox set. Every Draft can have one Standard Library set making a chain of standard libraries back to a root or top-level library.

Checking Compliance

The Standard Draft tree is a mechanism for determining compliance to the standard. For each object in a Draft ( a Form, Edit Check etc) TrialGrid follows the tree “up” back to the root looking for an object to compare to. Usually the system will look for an object with the same identifier (Name/OID) as the object in the Draft but you are able to customize this per-object so that you can have an object named “VT2” in a Draft and have it compare to an object called “VT” in the library.

In the following example, Draft 1 uses the AE form but its direct parent CNS Standards does not contain the AE form. The AE form is originally defined in the Core Standards:

Library Projects and Drafts

For every object in the Draft TrialGrid can determine if it is:

  1. Not found in the standard tree

  2. Found in the standard tree and is an exact match to the standard definition

  3. Found in the standard tree but is different to the standard definition

  4. Found in the standard tree, is different to the standard definition but has allowed changes.

If the object is not found or if it is different from the standard definition in a way that is not allowed then this should be explained.

Objects that come from other Libraries

Note that TrialGrid does not enforce copying objects from the Standard library. It is often convenient for the Study Builder to copy definitions for Forms or Edit Checks from a previous study or from a different Standard Library.

By default, all objects are compared against the Draft Default Library (the Library set at the Draft level for all objects to be compared against). But on a per-object basis this can be overridden so that objects can be copied from different libraries and still compared correctly.

In this example we can see the AE form is being compared to the Core Library version of this Form and the TA1 form is being compared against the version of the TA1 form in the TA Library.

Comparing against Different Libraries

TrialGrid provides assurance that whatever the source, the object matches the selected Standard library. This approach provides the Study Builder with freedom to design in the most efficient way for them while also tracking standards compliance with no extra effort.

Comparing Differences

If an object has been changed from the standard definition then it is helpful to understand what the changes are so that these can be explained and approved for the study.

TrialGrid provides a side-by-side color-coded comparison of objects in text form so that the differences can be quickly identified. Deletions are highlighted in red and additions in green.

Comparing Objects

The sidebar shows child objects (such as Fields in a Form) and whether they are matched between the compared objects. If Ordinals have changed then we would see Fields listed in a different order with lines drawn to match them up:

Comparing Objects Ordinals Changed

It is also possible for the view to show “Allowed Changes”. Some objects such as Forms and Fields can have rules set in the Standard Library version of the Form which allows some properties to be changed. This allows, for example, the Field Question text or Control Type to be changed without triggering a standards compliance warning. These changes are still shown in the compare view but they are shown as an “allowed change”.

Explaining and Approving Differences

When an object is not found in the Standard Library or is different from the standard definition, the Study Builder must explain this difference via a pop-up in the object listing. Once explained this difference can be Approved by a user with Manage Approval permission from their Project Role.

A user with Manage Approval permission may also Deny a change signalling to the requester that the change made is not acceptable. All Approval/Denial actions have an associated comment so that the requester can be given instruction on how to make the change acceptable.

If the object is changed after an approval or denial (e.g. to add a new Field to a Form, or a change in an Query message in an Edit Check) then the approval/denial is automatically removed and the difference must reviewed again. The states of objects can therefore be:

  • Not Found

  • Not Found : Explained

  • Not Found : Approved

  • Not Found : Denied

  • Deviation

  • Deviation : Explained

  • Deviation : Approved

  • Deviation : Denied

An audit trail is kept of the explanations and approvals for deviations from the standards.

Reporting on Compliance

A summary of compliance metrics is available on the Standard Compliance page. This page shows the overall counts of objects found in the Standard Library Drafts vs how many were not found because they were new or were changed.

A PDF report of the summary can be generated from the same page.