1: Database platform has feature for export of CRF field definitions and schema of table relations.

2: Dictionary has annotations as needed to provide guidance on coding decisions.

3: Dictionary cites primary sources where appropriate for uniform data collection (e.g., NINDS TBI CDEs) 

1: Criteria in place for closing and locking eCRFs in the database. 

1: For example, testing is carried out if fields such as ‘years of education’ and ‘level of education’ are automatically combined into a new variable summarising educational status.

2: Coding is tested on a subset of data, ideally by multiple members of the study team.

3: There is a centralised log / version management of all transformations used. 

1: Table and study form fields relationships are clearly identified in the data dictionary. 

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

2: Psychometric transformations considered.