Clinical research associate
- Clinical research associate
-
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 Contract Research Organization (CRO). 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 rules are codified in Title 21 of the Code of Federal Regulations. In the European Union these guidelines are part of EudraLex.
Clinical research associate certification
The Association of Clinical Research Professionals [1] (ACRP) provides a certification, specific to the job function one actually performs, for CRAs. ACRP offers the only accredited* CRA designation in the field, the Certified Clinical Research Associate (CCRA®).
- ACRP's CRC and CRA Certification Programs are accredited by the National Commission for Certifying Agencies (NCCA), the accrediting body of the Institute for Credentialing Excellence. For more information on accreditation, visit www.credentialingexcellence.org/ncca.
External links
Wikimedia Foundation.
2010.
Look at other dictionaries:
Clinical Research Associate — Der Klinische Monitor, auch Clinical Research Associate (CRA) oder Site Manager genannt, überwacht Klinische Prüfungen (KP, definiert nach Arzneimittelgesetz § 4, Absatz 23). Dies umfasst die Kontrolle der Durchführung nach den Vorgaben der Guten … Deutsch Wikipedia
Clinical research organization — The Clinical Research Organization (CRO), also known as a contract research organization, is an independent organization involved in the conduct of a clinical trial. A CRO is responsible for the Data Management (DM) and the communication between… … Wikipedia
List of clinical research topics — Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans. Contents 1 General topics 2 Drug terminology 3 T … Wikipedia
Clinical Cancer Research — Abbreviated title (ISO) Clin. Cancer Res. Discipline … Wikipedia
Monitoring in clinical trials — Clinical monitoring Oversight and administrative efforts that monitor a participant s health during a clinical trial. The government and other clinical trial funding agencies require data and safety monitoring boards to oversee clinical trials.… … Wikipedia
Clinical Associate (Psychology) — In the United Kingdom, a Clinical Associate is a shortened designation for a Clinical Associate in Applied Psychology (CAAP). A Clinical Associate is a specialist regulated mental health professional with expertise in the delivery of… … Wikipedia
Research assistant — A Research Assistant is a junior graduate scholar, employed on a temporary contract by a college or university for the purpose of academic research. A research assistant usually works on a project supervised by one or more full time academics… … Wikipedia
associate — 1. (a so′shi at)Any item or individual grouped with others by some common factor. 2. (a so′she at)To accomplish association. paired associates words, syllables, digits, or other items learned in pairs, so that when one is given, its a. is to be… … Medical dictionary
Academic clinical trials — are a valuable component of the health care system; they benefit patients and help determine the safety and efficacy of new drugs and devices.A typical area of academic clinical trials is the advancement and optimization of already existing… … Wikipedia
Good clinical practice — is an international quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human… … Wikipedia
