1: Clear Biospecimen Standard Operating Procedure (SOP) for sample preparation.

2: Lab SOP aligned with agreed sample handling standards.

3: Adequate training of lab personnel across sites.

4: Published / national / international standards should be specified and adhered to where possible.

5: Audit trail of sample processing and storage.

6: Protocol deviations filed when protocol not followed.

7: Audits of time intervals for drawing, processing and freezing are within protocol windows for each specimen type. 

1: Phantom standardization of MRI scanners across study sites.

2: Appropriate assurance of quality and comparability between sites and within sites and assurance of ongoing compliance over time.

3: SOP aligned with agreed imaging acquisition standards.

4: Adequate training of technical personnel across sites.

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: 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.