Page 19 - PATIENT REGISTRY DATA FOR RESEARCH: A Basic Practical Guide

of the countries in the world today. Although the study does not involve exposing any

intervention(s) to the patients and/or it does not even involve any interaction with the

patients, however ethics approval is still necessary to ensure that privacy and confidentiality

of all patient data are adequately protected in order that such data will not be abused. In

addition, most reputable journals will require ethical approval as a prerequisite for

publication.

Once the consent and the approval have been granted, the data can be transferred from

one party to the other in several ways, including by hand or by an external gadget (such as the

use of a CD or thumb drive), or via sharing through a password-protected cloud storage. It is

always advisable to take special precautions for handling all the patient data which are

collected by a registry because they are strictly confidential. Hence, both the data owner and

the researcher must adhere to a proper code of practice for data sharing procedures which will

duly ensure that confidentiality of all these patient data is strictly maintained at all times.

Apart from this, the terms of reference must also be carefully drafted between the both parties

so that they have been made aware of each other's rights and responsibilities after having

agreed to work together to accomplish a shared goal. It will also be ideal to carefully

document the terms of reference between the two parties for future reference.

2.2 Understand the Scope of a Registry

After having obtained prior consent and approval from all relevant authorities, the

next step is to understand the scope of data collection necessary to meet research needs for a

patient registry and the minimum standard of data quality necessary for fulfilling all the

purposes of the registry. Therefore, it is of utmost importance for the researcher to gain a

thorough understanding of the background of subject matter which underpins the content of a

registry by reading around the subject matter, its proposed method of data collection and all