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REDCap Variable Naming

It is recommended that variable naming follow the convention below, but it is not required. A section of a variable can be omitted if it is not applicable, for example, if a form does not have multiple sections or questions then the variables do not need to be numbered.

Due to the limitations of some statistics programs not being able to use variables longer than 26 characters, all of the variable components below are typically shortened words. They are shortened either by using the first part of the word, an acronym for the word, or using the full word with vowels removed. Use your own discretion to best maintain the word’s meaning while keeping the variable names at a reasonable length.

Form_Section_Question_Number_Desc

Form

Part of the variable used to designate which instrument/form a variable is on.

demog_

Demographics

mh_

Medical History

sf_

Self-Reported Questionnaire

Section

Part of the variable used to designate which section a variable is in. This part is applicable if a form has multiple sections.

sf_conmed_

Concomitant medications on a self-reported questionnaire

cg_seprof_

Drug side effect profile questions on a caregiver-reported questionnaire

Question

Part of the variable used to designate the question itself, this can be multiple parts if there are multiple parts to a question (i.e a sub-section). This part is applicable if questions are not numbered or if you want to have the variables be more representative of the question text.

demog_date

Date the demographics form was completed

sf_mh_cndtn_text_

Medical History item number 2/10 on a self-reported questionnaire

Number

Part of the variable used to designate the question number or item number; it should contain enough preceding zeroes to keep the variables’ lengths the same throughout the form. This part is applicable if a questionnaire has question numbers or if creating a log where multiple sets of the same variables are needed.

cg_mh_cndtn_text_002

Medical History condition 2/10 on a caregiver-reported questionnaire

gad_005

Question 5 on the GAD-7

Desc

Part of the variable used to designate if the variable is a Descriptive Text field. Typically, these variables will be named the same as the question variable they are associated with, with this suffix added.

sf_psqi_001_desc

Question text for PSQI Q1 on a self-reported questionnaire

gad_desc

Questionnaire instructions for the GAD-7

Option Coding

To ensure consistent coding of common options across Brain-CODE, some standard coding options were created. These should be followed unless there is a valid reason for an exemption. This coding should still be used if there are options that are similar but not the exact same, for example, “Do not know” and “Unknown”.

Coding

Field Option Label

9996

Other

9997

N/A

9998

Prefer not to answer

9999

Unknown

REDCap Project Validation Checklist

Common Data Elements (CDEs)

  • All relevant common data elements are added to the study

  • CDEs are the most recent version(s)

  • No changes have been made to the original

  • No CDE variable names were used for another eCRF

  • The Informed Consent Form (ICF) contains SQL consent field

  • ICF contains a Brain-CODE subject ID naming checker

Electronic Case Report Forms (eCRFs) and Patient-Reported Outcomes (ePROs)

  • Consistent formatting

  • 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 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

  • Naming is as intuitive as possible

  • Consistent abbreviations

  • Field labels are accurate

  • Fields have accurate descriptions and notes

Branching Logic

  • No errors 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

  • When applicable add range checks

    • For example - if the study is for participants older than 18, may have a range validation for age

  • Automated queries were tested for accuracy

    • Ensured no false positives

    • Ensured no false negatives

  • Range checks were tested 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 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 spelling errors

  • Each arm has at least one event

  • Data entry workflow intuitive and as simple as possible

  • No labels