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How do I comply with Good Clinical Practices (GCP)?
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Must I obtain continuing review from the IRB?
Who should monitor subject recruitment/retention?
How do I report adverse events?
How is data quality monitored?
What if I wish to add extra sites or studies to my project?
How do I manage my budget and when are reports expected?
What is HIPAA and how do I abide by the requirements?

Glossary Box

 

What is HIPAA and how do I abide by the requirements?

The Health Insurance Portability and Accountability Act was designed to protect individually identifiable health information of individuals who are living or deceased, and it regulates the risks to privacy that may accompany using and disclosing personal health information. The Office of Extramural Research
(OERGlossary Term) offers background information and resources to familiarize you with the HIPAA Privacy Rule. The rule has implications for the conduct of clinical research.  Specific information and FAQs from NIH about Clinical Research and the HIPAA Privacy Rule will help you to better understand how the Privacy Rule may affect your research when identifying potential participants or contacting research volunteers.

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