Principles and Practice of Pharmaceutical Medicine

CRFs cover sheet (Table 26.4)

Preliminary edit check document (Table 26.5)

Data query sheet (Table 26.6)

Data processing status (Table 26.7)

Audit sheet (Table 26.8)

Audit document (Table 26.9)

Summary of audit results (Table 26.10)

Sample memo of notifying formal closure of
database (Table 26.11)

26.4 Data processing

Log-in and scan rocess

To prepare the CRFs to be scanned into the com-
puter, do the following:

1. Verify the shipment of CRFs from clinical
   research department to the inventory of data
   management department (Table 26.3).


2. Check the CRFs to assure that the header infor-
   mation is accurate and complete.


3. Prepare the CRF file folder with the cover page
   (Table 26.4), which carries the following inf-
   ormation: batch number, site, patient ID, visit

number, log-in date and the initials of the person

who logged the CRFs. This will ensure that

the scanner will assign the patient information

to the correct fields of the electronic image files.

4. Scan CRFs into the computer image files.

CRFs image review process

This process is to ensure that unexpected data

problems or unusual interdata relations in various

data fields are identified. It is a very important step

in the data process: many companies have encoun-

tered data quality problems because of the lack of

this step, which is not included to replace the

computer edit check but rather to enhance it. The

basic principles for the image review are checking

Table 26.5 Preliminary edit check document

Protocol No.: Edit check programmer:

Name of drug: Version date:

CDC name: Revision date:

General checks:

(D-1) Subject initials should

be consistent throughout casebook

(D-2) All dates should be within

valid ranges

Inclusion criteria:

(D-1) Inclusion #1 should

be yes or no

(D-2) Inclusion #2 should

be yes or no

(D-3) Inclusion #3 should

be yes or no

(D-4) Consent date should

be equal to visit date

Exclusion criteria:

(D-1) Exclusion #1 should be yes or no

(D-2) Exclusion #2 should be yes or no

(D-3) Exclusion #3 should be yes or no

(D-4) Exclusion #4 should be yes or no

(D-5) Exclusion #5 should be yes or no or na

(D-4) Exclusion #6 should be yes or no or na

Demographics:

Efficacy:

Safety:

(etc.)

Table 26.4 CRFs cover sheet

Protocol No.: Site/investigator:
Name of drug: Patient No./Visit No.:
Data clerk name: Batch No.:
Process Date Initial
Log-in
Review
Key
Verify
Query
Audit

348 CH26 DATA MANAGEMENT