Principles and Practice of Pharmaceutical Medicine

CRFs COLLECTED BY CRAs

LOG-IN TRANSMITTALS PREPARE SCAN

VERIFY SCANNING INDEX INDEX QUALITY CONTROL INDEX ISSUE RESOLUTION

EDIT CHECK VERIFIED DATA

CLIENT / CRO / CRA

INVESTIGATE & CORRECT

AUDIT OF CRC DATA

FINAL DATA BA S E

QUERIES WITH RESOLUTIONS

ISSUE NEW QUERIES

Step 1

Step 2

Step 3

Step 4

Step 5

Step 7

Step 8

Step 6

Step 9

Step 10

ISSUE NEW QUERIES

KEYING OF CRFs VERIFICATION OF CRFs

ENTER “DATA ENTRY” QUERIES ENTER “EDIT CHECK” QUERIES

PROCESS RETURNED QUERIES CORRECT IMAGES & DATABASE

ALL QUERIES RESOLVED WITH IMAGES

HAS AUDIT BEEN DONE

CORRECTIONS NEEDED FROM AUDIT

YES

YES NO

NO

(double entry)

REVIEW & ANNOTATE CRFs ENTER INITIAL REVIEW QUERIES

Figure 26.1 Data creation flow chart

26.3 PROJECT SETUP 347