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Study phase:
Dimension:
32
There is automated entry of the results of biospecimen samples
Examples

1: Vial labels IDs entered into bio-repository logs via bar code scanner. 

Study phase:
Dimension:
31
Biospecimen assay accuracy, precision, repeatability, detection limits, quantitation limits, linearity and range are defined. Normal ranges are determined for each assay.
Examples

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. 

Study phase:
Dimension:
30
Biospecimen preparation techniques are standardised.
Examples

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. 

Study phase:
Dimension:
29
Imaging acquisition techniques are standardised (e.g. magnetic resonance imaging).
Examples

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.

Study phase:
Dimension:
28
For physiological data the methods of measurement and units are defined for all sites.
Examples

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. 

Study phase:
Dimension:
27
Data are provided in a form that is unambiguous to researchers.
Examples

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

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