Page 18 - PATIENT REGISTRY DATA FOR RESEARCH: A Basic Practical Guide

Chapter 2 - Data Acquisition

The first step in conducting research by using data from a patient registry database is

to set up the right and valid research objective. It is the responsibility of the researchers to

equip themselves with adequate prior knowledge of the subject matter in order to be able to

formulate the right and valid research objective. Once the research objective is set, the next

step is to retrieve the relevant data from a patient registry database. However, before

retrieving and analysing any patient registry data, it is first necessary to determine whether it

is truly feasible to retrieve the necessary data from a patient registry and also to analyse them

in order to address specific clinical research questions. Hence, the following description

provides a list of steps to take when planning to determine the feasibility of data collection

for a patient registry.

2.1 Obtain Prior Consent and Study Approval

The initial set-up of most registries is usually proposed by either the local government

(most likely by the Ministry of Health), or a group of specialists in which the registries are

formed as part of a non-government organization, NGO's initiative (Lim et al., 2008; Ali et

al., 2014; Wan-Ahmad & Liew, 2016). All clinical data obtained from each individual patient

are considered as confidential data. Hence, it is necessary to obtain prior consent from the

respective authorities for using these registry data for research purposes (including publishing

the results of any studies which are being conducted by using these registry data). After

consent has been successfully sought from all the relevant authorities, both parties (i.e. data

owner and researcher) will then need to agree upon to adhere to a set of data sharing

procedures that will prevent any potential breach(es) of patient confidentiality.

Besides seeking consent from the respective data owner, it is also necessary to obtain

study approval from the authorized ethics committee. These are common practices for most