Principles and Practice of Pharmaceutical Medicine

the ‘accuracy’, ‘completeness’ and ‘consistency’
of the data within a subject and across subjects.
This review and timely computer edit checks will
provide feedback to the monitoring staff concern-
ing a problematic investigator or CRF page, so that
corrective action of monitoring practice or

enhancement of the computer edit checks can be

implemented promptly. The review should include

the following:

1. Are there missing header information, missing
   pages and visits.

Table 26.7 Data process status

Protocol No.:

Name of drug:

CDC name:

Site/inv. Logged Reviewed Keyed Verified Audited

(no.) (%) (no.) (%) (no.) (%) (no.) (%) (no.) (%)

Total:

Table 26.8 Audit sheet

Protocol No.: Audit sheet programmer

Name of drug: Version date:

Name of CDC: Revision date:

CRF Page 1:

Eligibility criteria:

Initial: RLD Visit date: 02/10/97

Inclusion criteria

1234567

1111111

Exclusion Criteria

12345678 9 10 11

22222222 2 2 2

CRF Page 2:

Infection history:

Initial: RLD Visit date: 02/10/97

Number of infections in past year: 3

Therapy for infection in past year: 2

Medication: Drug aaa Effective: 1 Complete med.: 1

(etc.)

Table 26.6 Data query sheet

Protocol No.: Data submitted:

Name of drug: Date returned:

CDC name:

Site/pat. no. PageVisit Problem Resolution

Investigator signature: Date:

CRA signature: Date:

26.4 DATA PROCESSING 349