Introduction to Clinical Data
Clinical data is either collected during patient care or as part of a clinical trial program. Funding agencies, publishers, and research communities are encouraging researchers to share data, while respecting Institutional Review Board (IRB) and federal restrictions against disclosing identifiers of human subjects.
You should take initial steps to de-identify data for:
- Protecting data during research projects
- Preparing data for vetted collaborators, restricted-access or public access data repositories
Clinical Data Terminology
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Personal Identifiers
Private information that subjects expect not to be made public that are linked to information associated with a unique individual -
Types of Identifying Information
Identifying information is classified as one of two types: direct and indirect -
Anonymization
Used as a more broad term to encompass two types of tasks to reduce disclosure risk for identifiers -
HIPAA's Privacy Rule
Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to protect individuals’ medical records and other personal health information