Beginner CRA
CRA BASICS, TIPS AND CAREER DEVELOPMENT FOR ENTRY LEVEL CLINICAL RESEARCH ASSOCIATES OR THOSE INTERESTED IN BECOMING CLINICAL RESEARCH ASSOCIATES
Glossary
Clinical Research Abbreviation Index and Glossary:
GCP –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 use for regulation of clinical trials involving human subjects
ICF– Informed Consent Form, before enrolling a subject into a clinical trial the Principal Investigator or Study coordinator must provide the subject with an informed consent form. Each subject must sign the informed consent form
IRB– Institutional Review Board, approval by an IRB (or ethics board), is necessary before research can begin
FDA– Food and Drug Administration, is the regulatory agency within the United States that audits, and review and approves clinical trials and study drug before going to market
CRO-Clinical Research Organization or Contract Research Organization (used interchangeably), is an organization that provides support to the pharmaceutical industries in the form of research services outsourced on a contract basis
CRA– Clinical Research Associate, also known as monitors are responsible for over-site of clinical trials on the individual site level
PM– Project Manager, is usually the person a CRA reports to
Lead CRA– May be a person between the CRA and the PM, the CRA can report finding to the Lead CRA and the Lead CRA reports findings to the PM
SM– Study Manager, same as PM
PI– Short for Principle Investigator, this is usually the physician who conducts the clinical trial at a particular site. He or she is responsible for ensuring that the subject has signed the ICF
SC– Study Coordinator, is a position at the clinical research site this person is hired by the PI to coordinate the study. He or she is the most knowledgeable about the trial and is usually your first point of contact at the site
SD– Short for Study Drug, may also be referred to as the Investigational drug or product
OTC– Short for Over the Counter,r these are drugs that you can be purchased without a prescription
CRF– Case Report Form, this is the form that the study data is recorded on
EDC– Electronic Data Capture, an electronic version of CRF
Sponsor– The pharmaceutical company paying for the study and owner of the study drug
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