Principles and Practice of Pharmaceutical Medicine

2. Are randomization numbers allocated sequen-
   tially?


3. Are blanks are properly answered?


4. Check adverse events and prematurely discon-
   tinued subjects, with special attention to the
   comments for hidden information.


5. Has clinically significant laboratory abnormal-
   ity has been followed by the investigator?


6. Does the drug inventory match the number con-
   sumed?
   7. Clarify all text items, for example adverse
   events, concomitant medications, physical
   examinations, ECG, progress notes and so
   on.

Data entry and double entry

using CRF images

Autocode the data using structured glossaries,

including drug class, body system, preferred

term and verbatim term.

Table 26.9 Audit document

Protocol No.: Date audit start:
Name of drug: Date audit stop:
Auditor name:
Pat. no. Keyer Verifier CDC Auditor Type of audit No. of errors Description of errors

½ ka jp sr et Full 0
01/005 ka jp sr et Full 0
01/009 ka jp sr et Full 1 Med. His—‘Pnemonia’
should be ‘Pneumonia’
01/014 ka jp sr et Full 0
01/018 ev cc jf wa Full 0
02/005 js cc jf wa Full 1 Diary—3/24/98 bedtime
11:10 pm should be
at 11:00 pm

(etc.)

Table 26.10 Format of summary of audit result

Protocol No.: Date audit start:
Name of drug: Date audit stop:
Auditor names:
Page Data Variables/ Patient Records Values Error
description set No. patient No. audited No. checked No. checked No. Errors found rate (%)

Adv. Exper Adverse 26 497 558 14 508 0 0.0000
Study Complete 7 497 497 3 479 2 0.0575
Complete
Conc. Med. Conmed 18 497 602 10 836 4 0.0369
Eligibility Criteria 29 497 497 14 413 1 0.0069
Criteria
Diary Diary 160 497 497 79 520 17 0.0214
Drug Drugacct 6 497 497 2 982 1 0.0335
Accountab
Overall 27 0771 51 0.0188

350 CH26 DATA MANAGEMENT