Principles and Practice of Pharmaceutical Medicine

significant ranges, timelines, QC rules, QA
sampling, error analysis, criteria to release the
database, disaster recovery plan and so on. Most
of these rules and conventions are preliminary
and are collected from earlier studies. These
rules and conventions will be discussed by the
project team from time to time to make them
pertinent to the current studies.

26.2 Formation of the project

team

Pharmaceutical companies usually assign a project
manager to coordinate the formation of the project
team (Table 26.2). The project manager works clo-
sely with the functional department heads to select
the team members. The teamusually includesrepre-
sentatives from the departments of regulatory

affairs, clinical research, medical writing, biostatis-

tics, data management, programming and document

supports. The project manager should coordinate

theactivitiestomakesurethattheteamhasadequate

resources; the project information is distributed in a

timely fashion; the status is issued; milestones are

reached at each stage; and the team members have a

clear and detailed instruction of the priorities of the

various protocols. For multinational projects, the

quality of CRFs varies from country to country. It

requires a great deal of management skill on the part

of the project manager to balance national pride and

quality requirements without sacrificing the quality

of the final database.

26.3 Project setup

From the data management perspective, the clin-

ical data coordinator (CDC) is the central team

member receiving and distributing data-related

information to the project team members. The

CDC meets with the project team members to

review the project material collected and to elicit

the rules and special requirements from the statis-

tician, clinician, safety officer, medical writer and

regulatory associates. These project materials,

rules and special requirements will be considered

in conjunction with data management require-

ments to develop the data management plan. The

CDC should prepare the following documents

before the clinical trials are initiated:

Data creation flow chart (Figure 26.1)

Project team personnel list (Table 26.2)

CRFs log-in sheet (Table 26.3)

Table 26.1 Duration of exclusivity for some
major drugs

Drug name Year approved Exclusivity (years)

Inderal 1968 10
Tagmet 1977 7
Capoten 1980 5
Prozac 1988 4
Diflucan 1990 2
Recombinate 1992 1
Invirase 1995 0.25

Table 26.2 Project team personnel list

Protocol No. Project team
coordinator:
Name of drug: Directory location:

1. Regulatory associate:


2. Clinician/medical writer:


3. Primary statistician:


4. Secondary statistician:


5. Scanner


6. Primary CDC


7. Secondary CDC


8. Data entry screen designer


9. Edit check programmer


10. Quality assurance


11. Data entry


12. Data verifier

Table 26.3 CRFs log-in sheet

Protocol No.:

Name of drug:

Data Clerk name:

1. Log-in date:


2. Investigator number and name:


3. Patient number/initial:


4. Book/visit number:


5. Batch name:


6. Comments:

346 CH26 DATA MANAGEMENT