Principles and Practice of Pharmaceutical Medicine

consistency and unrecognized errors once they are
received in-house. The use of computer edit and
logic checks supports this effort, where computer
output is verified against CRF data. Discrepancies
are identified and CRF queries are generated for
resolution.
The goal of managing CRFs is to get the data
from the CRFs to a clean database in the fastest
time possiblewhile maintainingthehighestlevel of
quality. To accomplish this task, CRFs must be
ready for data entry at the site. CRFs must be
cleaned on an ongoing basis during the study. To
do this, efficient systems must be incorporated to
simplify the query process. The approach used by
some sponsors permits electronic exchange of CRF
data between the investigator, monitor and data
entry personnel. SDVis still a fundamental require-
ment even when utilizing electronic data capture
and exchange. Computerized checking programs
and edit checks make the process more value-
added for the monitors.
Clinical teams should design database before the
trial begins, reduce the amount of data collected,
use standardized CRFs and complete the review
process on an ongoing basis. The philosophy is ‘do
it right, first time’ at the source.
To be successful, the staff must know how to
prepare CRFs for data entry, be able to verify
database consistency with original records and
CRFs and assure that queries are handled effec-
tively.

Competencies associated with
reporting clinical research

Preparing clinical study reports

The requirements for reporting clinical trials to
international regulatory authorities are similar in
intent but differ in detail. Sponsors approach pre-
paration of NDA/BLA/MAA documentation in a
modular format. Each module satisfies a specific
documentation need. The modules are generally
organized as follows:

Module I: Includes a basic summary of the study
not unlike a publication. It includes study ratio-

nale, objectives, methods, results and conclu-

sions. Module I also has a large appendix

which includes list of investigators, drug lot

numbers, concomitant diseases and medica-

tions, intent-to-treat analysis, patient listings of

adverse events and relevant laboratory abnorm-

alities and publications on the study.

Module II: Includes the protocol and any mod-

ifications, CRF, detailed methodology and the

glossary of original terminology and preferred

terms.

Module III: Presents the detailed efficacy find-

ings including the intent-to-treat analysis popu-

lation and the efficacy data listings.

Module IV: Presents the detailed safety findings

including the intent-to-treat analysis population

and the safety data listings.

Module V: Includes individual center summary

reports, quality assurance measures, statistical

methods and analyses and randomization lists.

The skills necessary to prepare a clinical study

report include

advanced research design, methodology and sta-

tistics;

preparation and review of study tabulations;

ability to confirm that study tabulations conform

to protocol design;

ability to verify study tabulations against com-

puter data listings;

clarification of outstanding issues regarding data

analysis and presentation;

drafting of assigned study report sections

according to the clinical study report prototype;

interpretation of adverse events;

interpretation of laboratory findings;

3.3 COMPETENCY-BASED TRAINING PROGRAM FOR STAFF ASSOCIATED WITH CONDUCTING CLINICAL TRIALS 37