Content Comparison

During Project Validation, an Indoc IDP Support Lead will review and test a study’s REDCap project 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 (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

• 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

• Tested all fields 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

• 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

...

• All calculated fields were manually calculated to ensure accuracy of the equation used

• When applicable add range checks

  For example -

  Range checks have been added where applicable (i.e., 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

...

• 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 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

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