1: Training materials developed and disseminated via print, webinar or in-person training.

2: Study implementation checklist includes documentation for training requirements according to study personnel roles.

3: Testing process in place: written exams with scenarios for coding data; video demonstrations for examiner competency to administer of outcome assessments; competency for performing research imaging sequences; or testing with mock patient records for complex forms.

4: Post-launch procedures for assuring new project personnel also fulfill training requirements.

1: Avoid enrollment errors by requiring completion of a CRF with checklist confirming that eligibility criteria have been met for enrolled subjects.

2: For subjects that need to be enrolled within specific window of time there are timestamp checks in the eCRF in place to verify the eligibility window.

3: Date of birth falls within the enrollment age criteria. 

1: ‘Other’ checkbox included in field response options as appropriate with free field text for description.

2: Free-text fields set as containing PHI to avoid inadvertent export/release of personal information. 

1: When data is extracted from the database, it should be easy to recognize what the variable names refer to.

2: When there are many variables of the same kind, the names follow a pattern that is consistent.

3: The same name should be used across the CRF and database design so that confusion is minimised. 

1: CRF design teams were designated and followed a defined process for end-user acceptance testing to ensure it aligns with the workflow and research milestones.

2: Design and testing included experts in areas under study such as database design and curation; statistics, neuroimaging; biospecimen management; outcome assessments; and clinical assessments etc.

3: Before data entry was started, the CRF forms were reviewed by an independent researcher with appropriate expertise.