Plausibility

40

admin — Fri, 20 Mar 2020 15:40:59 +0000

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

Reliability checks have been performed on variables that are critical to research hypotheses, to ensure that information from multiple sources is consistent.

Examples

1: Database rule checks in place to identify conflicts in data entries for related or dependent data collected in different CRFs or sources.

2: Inter-rater scoring of MRIs is done independently by 3 experts on 10 cases per month.

Run-time

Plausibility

38

admin — Fri, 20 Mar 2020 15:39:36 +0000

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

Systematic and timely measures are in place to assure ongoing data accuracy.

Examples

1: Schedule of standard reports for data quality checks.

2: Ad hoc reports for identification of new issues.

Run-time

Plausibility

37

admin — Fri, 20 Mar 2020 15:39:00 +0000

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

Individual data elements should be checked for missingness. This should be done against pre-specified skip-logic / missingness masks. This should be performed throughout the study data acquisition period to give accurate ‘real time’ feedback on completion status.

Examples

1: Rules in place to check whether the apparently missing element should be completed or not for a particular study stratum or time point.

Run-time

Plausibility

18

admin — Fri, 20 Mar 2020 15:07:48 +0000

18 admin Fri, 03/20/2020 - 22:07

Extract / transform / load software for batch upload of data from other sources such as assay results should flag impossible and implausible values.

Examples

1: ETL process logged.

2: Permissible value ranges in the ETL software are study specific rather than relying on institution permissible value logic.

Design-time

Plausibility

11

admin — Fri, 20 Mar 2020 15:02:40 +0000

11 admin Fri, 03/20/2020 - 22:02

Range and logic checks are in place for CRF response fields that require free entry of numeric values. Permissible values and units of measurement are specified at data entry.

Examples

1: Avoid free text fields when possible.

2: eCRF has automated error flags to prompt immediate alert to review entries that don’t pass validation with option to override when appropriate.

Design-time

Plausibility