1: Manuals compiled by multidisciplinary team of stakeholders and involve data curation expertise. For example,   Imaging studies and biospecimen collection procedures are detailed for study personnel and end-users.

2: Manuals specify how eCRF data is collected, when, by what metrics and under what conditions.

3: CRF fields have links to relevant data manual sections. 

1: Systematic approach to translation and cross-cultural validation of study material in multi-language settings.

2: Psychometric transformations considered. 

1: ETL process logged.

2: Permissible value ranges in the ETL software are study specific rather than relying on institution permissible value logic. 

1: Where decimal places are to be limited, it should be clear to the user and prevent them from entering the value rather than a truncation performed with the user being unaware.

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: For data entry: cells for skipped questions are closed.

2: Clear directions on CRFs for when to skip questions.