Clinical research associate: Difference between revisions
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A '''clinical research associate''' ( | |||
A '''clinical research associate''' (CRA) is a profession defined by [[Good clinical practice]] guidelines ([[International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use|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 code of federal regulations is known as Title 21 of the Code of Federal Regulations. In the European Union these guidelines are part of [[EudraLex]]. | 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 code of federal regulations is known as Title 21 of the Code of Federal Regulations. In the European Union these guidelines are part of [[EudraLex]]. | ||
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*[http://trials.in.ua/eng/ Society of Clinical Research Associates in Ukraine] | *[http://trials.in.ua/eng/ Society of Clinical Research Associates in Ukraine] | ||
[[Category:Clinical research]] | [[Category:Clinical research]] |
Latest revision as of 23:57, 8 August 2012
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 code of federal regulations is known as Title 21 of the Code of Federal Regulations. In the European Union these guidelines are part of EudraLex.