The term SOP is widely used in business management practices. SOP means Standard operating procedures. Now, for a patient, a clinic or a hospital might be a place for saving lives, but it is also a place for business to its shareholders. So how do SOP works in clinics or hospitals? In this article we will learn about the clinical research standard operating procedures (SOPs).
Patient confidentiality is an ethical and legal consideration when drafting Clinical Research Standard Operating Procedures (SOPs). The purpose of a Clinical Trial SOP is to outline the procedure used to protect confidential subject information for personnel or designees. The objective of this standard operating procedure (SOP) is to describe the methodology, process, and the responsibilities for maintaining confidentiality of subject information within clinical research in compliance with the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP) and applicable data protection laws, privacy laws, and regulations (e.g., the US Health Insurance Portability and Accountability Act of 1996 [HIPAA], the European Data Protection Directive 95/46/EC and its implementation into national law [known as “Privacy Requirements”]).
Protected Health InformationI is a combination of health information (e.g., diagnosis, condition, equipment, name of provider), AND one or more of the following identifiers:
b) Geographic information smaller than a state (includes home address)
c) Date elements related to subject (admission, discharge, birth, etc.)
d) Telephone number(s)
e) Fax number(s)
f) E-mail address(es)
g) Social security numbers or other government-issued identification number(s)
h) Financial information (e.g., credit card data)
i) Medical record number(s)
j) Health plan numbers or health care identifier(s)
k) Account number(s)
l) Certificate/license number(s)
m) Medical device serial number(s)
n) Vehicle identification (license plate/serial number)
p) IP address(es)
q) Biometric identifier(s) (finger/voice prints)
r) Full face photo
s) Any other unique identifier(s) When working on a project that involves many different stakeholders, such as a CRO, sponsor and Clinical Site, it is important to identify which policy to use. This is an aspect that needs to be outlined before any Clinical Trial or handling a project for an outside Client. Often the Sponsor’s policies, procedures, and/or applicable forms and templates are following, if they have them. Most often the case is the Clinical Investigator Site must use their own set of standard operating procedures for patient confidentiality. When this occurs it is critical that a site can identify what is protected health information.