1: Change logs maintained and audited.

2: Workflows and ETL (extract / transform / load) processes are described. 

1: Therapists administering the Functional Independence Measure (FIM) tool do not know who was given an experimental treatment or a placebo.

1: Certification processes specified in protocols.

1: Random audits of clinical source documents against data entered on hard copy and eCRFs.

2: Double data entry audits of selected forms that are known to be prone to errors.

3: Audit of eCRF and hard copy logs for biospecimens; audit of complex assessments by experts.

4: Training and on-line documentation of how to handle exceptions.

1: Layout of paper and eCRFs are easy to navigate with simple wording.

2: Examples are provided for coding of complex response choices.

3: The CRF is designed and validated to be unambiguous to different users.

4: eCRF forms are designed to be presented based on rules to appear at times that are appropriate depending on the study design: Hiding irrelevant forms and to function as a prompt to promote timely data collection. 

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.