REDCap Project Validation Checklist

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 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

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

Calculated Fields, Range Checks and Automated Queries

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

• Range checks have been added where applicable (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

Required Fields

• All fields that are required are marked wherever possible

• Fields are not inappropriately marked as required – causing errors in saving forms

• Fields are properly designated as required – as to not prevent survey respondents from properly filling out ePROs

Survey Formatting

• 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

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