1: Vial labels IDs entered into bio-repository logs via bar code scanner.
1: Normal ranges are determined for each assay.
2: Assays are standardised as far as possible.
3: Assay substrate are defined (e.g. ionised vs. unionised fractions, whole blood vs serum, total vs protein bound as appropriate).
4: Normal ranges should consider/be customised to pathology or subject group in question.
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: Uniform collection standards are in place.
2: When uniform measures are not used by hospital units or labs, the CRF provides conversion guidance.
3: Inter-site sampling differences are described in the data dictionary.