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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 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

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

    • For example - 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

  • No labels