Clinical research associate
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 trial
s. 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 Form
s (CRF
s) 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
.
Profession
A profession is a vocation founded upon specialized educational training, the purpose of which is to supply disinterested counsel and service to others, for a direct and definite compensation, wholly apart from expectation of other business gain....
defined by Good clinical practice
Good clinical practice
Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...
guidelines (ICH GCP).
The main function of a clinical research associate is to monitor clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
s. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer
Freelancer
A freelancer, freelance worker, or freelance is somebody who is self-employed and is not committed to a particular employer long term. These workers are often represented by a company or an agency that resells their labor and that of others to its clients with or without project management and...
or for a Contract Research Organization
Contract research organization
A contract research organization, also called a clinical research organization, is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services...
(CRO). A clinical research associate ensures compliance with the clinical trial protocol
Clinical trial protocol
A clinical trial protocol is a document that describes the objective, design, methodology, statistical considerations, and organization of a clinical trial...
, checks clinical site activities, makes on-site visits, reviews Case Report Form
Case Report Form
A Case Report Form is a paper or electronic questionnaire specifically used in clinical trial research. The Case Report Form is the tool used by the sponsor of the clinical trial to collect data from each participating site...
s (CRF
CRF
CRF may refer to:Science and technology* Corticotropin-releasing factor, also called corticotropin-releasing hormone and corticoliberin, is a polypeptide hormone and neurotransmitter involved in the stress response...
s) and communicates with clinical research investigators. A clinical research associate is usually required to possess an academic degree
Academic degree
An academic degree is a position and title within a college or university that is usually awarded in recognition of the recipient having either satisfactorily completed a prescribed course of study or having conducted a scholarly endeavour deemed worthy of his or her admission to the degree...
in Life Sciences and needs to have a good knowledge of Good clinical practice
Good clinical practice
Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...
and local regulations. In the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, the rules are codified in Title 21 of the Code of Federal Regulations
Title 21 of the Code of Federal Regulations
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration , the Drug Enforcement Administration , and the Office of National Drug Control Policy ....
. In the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
these guidelines are part of EudraLex
EudraLex
EudraLex is the collection of rules and regulations governing medicinal products in the European Union.-Volumes:EudraLex consists of 10 volumes:*Concerning Medicinal Products for Human use:**Volume 1 - Pharmaceutical Legislation....
.
Clinical research associate certification
The Association of Clinical Research Professionals http://www.acrpnet.org/certification (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.