Clinical research associate
From Wikipedia, the free encyclopedia
A clinical research associate (CRA) is a profession defined by Good clinical practice guidelines (ICH GCP).
The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a CRO organizantion. A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators. A clinical research associate is usually required to possess an academic degree in Life Sciences and needs to have a good knowledge of Good clinical practice and local regulations. In the United States, the code of federal regulations is known as Title 21 CFRs. In the European Union these guidelines are part of EudraLex.
[edit] External links
- International Conference on Harmonisation
- United States Food and Drug Administration
- Society of Clinical Research Associates (United States)
- Association of Clinical Research Professionals (United States and United Kingdom)
- Clinical Research Nurses Association (United Kingdom)
- The Belmont Report: Ethical Principles and Guidelines for Research Involving Human Subjects
- Association of Clinical Research Professionals (Russia, Ukraine)
- Health Canada requires manufacturers to retain in the premises 16 types of records
