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Research for new drugs is an ongoing process. It is expensive, energy-consuming, and time-consuming.
An investigational new drug (IND), a new health product, or a new treatment for an existing product must undergo strict research studies and tests before it is made available to the public. This can sometimes take up to fifteen years!
Clinical trial management (research) is a stringently regulated process in which human subjects (volunteers) participate in a research study.
During these studies, human subjects are monitored by specific procedures that are outlined in the study's protocol (design). Data is collected and analyzed, based upon the protocol. Safety (how safe a study drug or a mechanical device is for the human subject) and efficacy (how well the drug or the device is in treatment) are monitored closely.
There are typically four phases during a drug's development, during which safety and efficacy are constantly monitored. The following are simplified definitions:
ACRP delineates separate definitions of two, among many, personnel who are involved in the conduct of a study: Clinical Research Coordinator (CRC) and Clinical Clinical Research Associate (CRA).
A CRC is employed on the study staff at a clinical site (a medical facility, such as a doctor's office or a hospital) where the study is conducted. Typically referred to as CRCs, these are study coordinators, research nurses, or site managers. ACRP offers certification and continuing education programs to members and non-members.
SoCRA defines a Clinical Research Associate (CRA) as someone who "functions as an administrator, coordinator, consultant, educator, or researcher" in clinical trial management. SoCRA offers certification and continuing education programs for members and non-members.
DIA is an organization in which health professionals exchange and share information on the discovery, development, evaluation, and utilization of health care medicines and technologies. The DIA provides opportunities for continuing education to professionals.
The CRA Registry is an organization with whom auditors, monitors, data reviewers and study coordinators can register their resumes for potential employers such as CROs, Pharmaceutical sponsors, and Medical Device companies.
There are several organizations that monitor the participation and the safety of human subjects in drug studies, as well as regulate the conduct of research studies, worldwide. The International Conference on Harmonisation is one organization in which regulatory authorities from Europe, Japan and the United States join with experts from the pharmaceutical industry to discuss scientific and technical aspects of product registration. In the United States, The Food and Drug Administration (FDA) regulates drug research and development process. Institutional Review Boards (IRBs) are regional, state, or local agencies that ensure the safety of human subjects.
The CRC functions under the supervision of a principal investigator (usually a physician) who is legally responsible for the conduct of the study, as outlined by certain regulations of The Food and Drug Administration (FDA). Guidelines to Good Clinical Practices (GCPs) are followed to protect the rights and welfare of human subjects and to ensure the quality, integrity and transparency of data in clinical trials.
Some of the many responsibilities of a CRC include:
Many CRCs perform additional duties:
As you can see, a CRC is a very important and active participant on the study team.
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