Design-time

Study phase:
Design-time
Dimension:
Completeness
2
There is a robust process for choosing and designing the dataset to be collected that involves appropriate stakeholders, including a data-curation team with appropriate skill mix.
Examples

1: Data governance team should include all the important and key stakeholders such as: data curator, steward, analysts.

2: Subject matter experts should be involved from the outset (study design time) to ensure that the data is sufficient and aligned to fullfill the study objectives.

3: Technical experts should be involved from the outset (study design time) to ensure that the variables to be collected are appropriately specified.

Study phase:
Design-time
Dimension:
Correctness
1
The case report form (CRF) has been designed by a team with a range of expertise.
Examples

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. 

Subscribe to Design-time