Despite the holiday season it has been a busy month at TrialGrid. We hosted two audits in July and our Quality Management System and approach to validation continues to be well received by Auditors. At the same time, we managed to make more than 60 changes to the system including improvements to the UAT functionality and the addition of 11 new Diagnostics, bringing our total to 119.
All of these new Diagnostics were suggested by customers and our policy on these is really simple - if a suggested Diagnostic would be useful to all our clients, we implement it for free. As a result, we have a backlog of 30-40 new Diagnostics to add over the coming months. Big thanks to all our contributors!
As well as adding the following Diagnostics we also added new options to many existing Diagnostics (e.g. to ignore inactive Fields, Forms and Edit Checks). In all, our 119 Diagnostics have more than 300 settings which all you to customize the operation of the Diagnostics to your own standards.
0109 : Fields should NOT have a SAS Format Specified
As you know, if you don't set a specific SAS Format for a Field then Rave will assign one. Depending on your work practices you might choose to always use Rave defaults (this Diagnostic) or specify your own formats.
If you choose to specify your own formats then you will likely want to use Diagnostic 0051 : Fields should have a SAS Format Specified which is the exact opposite of 0109.
This highlights the importance of selecting Diagnostics which match your own best practices. The easiest way to manage this is to set up standard sets of Diagnostics (and their associated settings) in a TrialGrid Project. These standard settings can then be imported into any other Project.
We can suggest a set of core Diagnostics and help you set up a standard library of Diagnostics you want to run.
0110 : ePRO Forms should not require signature
This should be self-evident but its easy to make a mistake here.
0111 : Ensure a set of Custom Functions exist in a Draft
When you have Custom Functions that call other custom functions via PerformCustomFunction it's easy to forget to include those additional CFs in your study draft. Rave won't recognize there's a problem until you start testing your Edit Checks and it discovers that the dynamically called Custom Function doesn't exist. This Diagnostic ensures that one or more required Custom Functions appear in the Draft.
0112 : Targets of Set Dynamic Search List Check Actions should have a Control Type of DynamicSearchList
In Rave you set a Field to be a Dynamic Search List via a Check Action but the Field itself has to be set to have a DynamicSearchList control or you won't be able to publish the Draft. This Diagnostic tells you sooner.
0113 : Primary Form may not have Dynamic Search Lists
Speaking of Dynamic Search Lists, did you know that they cannot appear on the Primary Form or the Draft cannot be published? This Diagnostic will catch that for you.
0114 : Forms should have Confirm Save set
Rave has four settings for Save Confirmation - No Confirmation (Save Confirm Checkbox unchecked), No Link, Link Next and Link Custom. You can use this Diagnostic to ensure Forms are not set to "No Confirmation".
If you want to enforce a particular Confirmation Style you can use Diagnostic 0074. Note that RaveEDC (formerly RaveX) only supports some of the Confirmation options and Diagnostic 0074 was updated to provide even more control over the types of confirmation links you allow in your studies.
0115 : Ensure specific Forms/Folder/Matrix combinations exist
This Diagnostic checks that specific Form/Folder combinations exist in either specific Matrices or in Any Matrix. If a combination exists but the Form is inactive then a warning is given. You would use this Diagnostic to ensure that standard Forms appear where you would expect them to in your studies e.g. an IVRS integration Form or a study withdrawal Form.
0116 : Ensure specific Forms/Fields have Set Folder Observation Date checked
When you are using Rave's subject calendar features you'll need to ensure that the Folder Observation Date is checked. This Diagnostics ensures that key Fields have the necessary options set.
0117 : Check name of Primary Form
If you have a standard for the name of your enrolment form this Diagnostic will help you enforce it. The Diagnostic checks that the Primary Form for the Draft has a specific name or matches a specific pattern (e.g. contains the word "Subject").
0118 : Check Draft Confirmation Message and Signature Prompts match expected text
This Diagnostic checks that the Save Confirmation Message and Signature Prompt text for the Draft exactly match the values provided. This allows organizations to ensure that their legal wording is being reproduced precisely in study designs.
0119 : Fields of ControlType CheckBox should not be used except on a specific set of Forms or Fields
Some organizations do not use CheckBox controls except in specific circumstances. Checkboxes have a value of Checked (1) or Unchecked (0) which makes it difficult to know if a user deliberately chose not to check a box or overlooked the question.
If you are already a TrialGrid user, check the online help for the latest Release Notes on Beta. We will soon be pushing a new version (Version 14) to the pre-production environment and contacting customers to announce the Production release date.