During Project Validation, an Indoc IDP Support Lead will review and test the a study’s REDCap project created by the IDP Neuroinformatics Lead to ensure that data integrity standards are met using the Validation Checklist shown below. A Validation Report that includes a list of any items flagged during the validation process, will be created and sent to the Neuroinformatics Lead for review.
Common Data Elements
All relevant common data elements (CDEs) are added to the study
CDEs are the most recent version(s)
No changes have been made to the original CDEs
No CDE variable names were used for another eCRF
The Subject Enrolment and Informed Consent Form contains a SQL consent field that queries the Ethics Tracking Database
The Subject Enrolment and Informed Consent Form contains a Brain-CODE Subject ID naming checker
Relevant Missing Data Codes have been added to the project
Electronic Case Report Forms (eCRFs) and Patient-Reported Outcomes (ePROs)
Consistent formatting is used
Fonts (type, colour, size) are consistent throughout and are legible
No spelling errors
All units are included (time, temperature, height, etc.)
Option coding matches paper versions
Validation
Limited number of free text fields
Numeric fields only allow for integers or double numbers
Email address fields have email validation
When applicable ontology validation is used
All fields have been manually tested with validation checks to ensure that they were functioning
eCRF/ePRO Variables
Consistent naming (eCRF has a prefix for all variables)
Numbers in variables have leading zeroes
No spelling errors are present
Naming is as intuitive as possible
Abbreviations are consistent
Field labels are accurate
Fields have accurate descriptions and notes
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All calculated fields were manually calculated to ensure accuracy of the equation used
Range checks have been added where applicable
For example -(i.e., if the study is for participants older than 18, a range validation may be used for age)
Automated queries were tested for accuracy
Ensured no false positives
Ensured no false negatives
Range checks were reviewed for accuracy
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Autonumbering is turned off when ePROs are already labelled with custom numbering
If required, proper “STOP” actions are included
If required, hidden fields/read-only fields are included and properly formatted
Survey is appropriately formatted for its length
For example - one page for short ePROs, multiple pages for long ePROs
Font of Survey is legible and uses default OBI color scheme
Instructions for survey are available
Survey administration matches protocol
Study Design
Correct Data Access Groups have been set up for sites
Each eCRF has been assigned to at least one event in the Event Schedule Grid
Event grid matches study protocol
Arms are appropriately labeled and do not contain spelling errors
Each arm contains at least one event
Data entry workflows are as intuitive and as simple as possible