Page 20 - PATIENT REGISTRY DATA FOR RESEARCH: A Basic Practical Guide

terminologies adopted by the registry. This can be achieved by gleaning relevant information

from the instruction manuals of other similar registries and also from any previous

publications of the same registry.

One of the ways to understand the scope of a registry is by reviewing its Case Report

Form (CRF). The CRF is a structured questionnaire designed to collect information from the

patients. It is a questionnaire where specific details of each individual patient including

his/her profile, history of disease, treatment and outcomes are recorded (Please see Appendix

2). The researcher should also carefully examine the design of a CRF, including the

definitions of all its variables, in order to assess whether the data collected by the CRF meet

the minimum data requirement set by the researchers. It is also strongly recommended for

both the CRF and its accompanying instruction manual to be kept for future reference. If the

researcher has any doubts about the data collection procedures of a registry and/or the data

collected by its CRF, it would be in his/her best interest to seek for a clarification with the

person in-charge of data management for the registry data at the earliest opportunity.

Next, the researcher should determine whether the data collected by the registry will

be able to address all primary and secondary research objectives of the study. This will

involve a careful assessment of whether the registry is collecting all the necessary data which

are required by the researchers and also whether the sample size deployed by the study will

be adequate for fulfilling all research objectives of the study. The researcher should also

carefully screen through the CRF to confirm if all the variables that will be collected by the

CRF are actually reported in the registry database.

Notwithstanding the above, it is always possible for some of the variables found in the

registry not to be collected by all participating centres, which could possibly due to a lack of

comparable, standardized data entry mechanism (i.e. pending data entry) or sometimes due to

a lack of IT support from the staff at the participating centre. This will result in the presence