During Project Validation an Indoc IDP Lead will validate the 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 will be created with a list of any items flagged during the validation proecand sent to the Neuroinformatics Lead which
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 (ICF) contains a SQL consent field ICF that queries the Ethics Tracking Database
The Subject Enrolment and Informed Consent Form contains a Brain-CODE subject Subject ID naming checker
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
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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
Tested all fields All fields have been manually tested with validation checks to ensure that they were functioning
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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
Consistent abbreviationsAbbreviations are consistent
Field labels are accurate
Fields have accurate descriptions and notes
Branching Logic
No errors occur due to branching logic
Branching logic is designed to mimic paper CRF
All branching logic has been tested for logic and correctness
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All calculated fields were manually calculated to ensure accuracy of the equation used
When applicable add range checksRange checks have been added where applicable
For example - if the study is for participants older than 18, may have 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 tested reviewed for accuracy
Required Fields
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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 w/o do not contain spelling errors
Each arm has contains at least one event
Data entry workflow workflows are as intuitive and as simple as possible