Correctness

45

admin — Fri, 20 Mar 2020 15:44:09 +0000

45 admin Fri, 03/20/2020 - 22:44

A plan for ongoing curation and version control is specified.

Post-collection

Correctness

42

admin — Fri, 20 Mar 2020 15:42:06 +0000

42 admin Fri, 03/20/2020 - 22:42

Data irregularities are reported back to data collectors in a systematic and timely process. There is a standard operating procedure for data irregularities to be reported back to the data collectors and for documentation of the resolution of the issue.

Examples

1: Queries in place to identify the following types of scenarios: For 9 of 10 study sites a mandatory and critical variable is only missing in 5% of the subjects. For site 10 data is found to be missing in 30% of the subjects. For a single site study, several personnel have been collecting longitudinal study data with low numbers of missing data. A pattern of increasing numbers of missing data has been identified with a newly hired data collector.

2: Variables known to be problematic are regularly monitored by curation team and delays in site resolution of issues are reported to governing committee.

3. Aggregate data are examined for inconsistencies such as lower average mortality in patients with GCS 3 than GCS 4-5.

Run-time

Correctness

41

admin — Fri, 20 Mar 2020 15:41:36 +0000

41 admin Fri, 03/20/2020 - 22:41

Scoring of tests is checked. Scoring is performed automatically where possible.

Run-time

Correctness

39

admin — Fri, 20 Mar 2020 15:40:21 +0000

39 admin Fri, 03/20/2020 - 22:40

Source data validation procedures are in place to check for agreement between the original data and the information recorded in the database.

Examples

1: Site visits for audit of subject hospital records against CRF and eCRF entries.

2: Submission of redacted hospital records for audit against eCRF entries.

3: Independent double entry of any data transferred to the database from paper form, either for full dataset or for representative subset.

Run-time

Correctness

32

admin — Fri, 20 Mar 2020 15:29:21 +0000

32 admin Fri, 03/20/2020 - 22:29

There is automated entry of the results of biospecimen samples

Examples

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

Design-time

Correctness

31

admin — Fri, 20 Mar 2020 15:28:44 +0000

31 admin Fri, 03/20/2020 - 22:28

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.

Design-time

Correctness

30

admin — Fri, 20 Mar 2020 15:27:48 +0000

30 admin Fri, 03/20/2020 - 22:27

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.

Design-time

Correctness

29

admin — Fri, 20 Mar 2020 15:26:58 +0000

29 admin Fri, 03/20/2020 - 22:26

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.

Design-time

Correctness

26

admin — Fri, 20 Mar 2020 15:24:15 +0000

26 admin Fri, 03/20/2020 - 22:24

There is a clear audit chain for any data processing that takes place after entry, and this should have a mechanism for version control if it changes.

Examples

1: Change logs maintained and audited.

2: Workflows and ETL (extract / transform / load) processes are described.

Design-time

Correctness

25

admin — Fri, 20 Mar 2020 15:12:30 +0000

25 admin Fri, 03/20/2020 - 22:12

Assessors are blinded to treatment allocation or predictor variables where appropriate and such blinding is explicitly recorded.

Examples

1: Therapists administering the Functional Independence Measure (FIM) tool do not know who was given an experimental treatment or a placebo.

Design-time

Correctness