Major Players in Clinical Research are
Sponsor
Principal Investigator(PI)
Independent Ethics Committee(IEC) or Institutional Review Board(IRB)
or Ethics Committee(EC)
Contact Research Organisation (CRO)
Monitor/ Clinical Research Associate(CRA)
Site Management Organisation (SMO)
Clinical Research Co-ordinator (CRC)
Sponsor :
In the regulations a sponsor is defined as “a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or a pharmaceutical company…”
Sponsors are responsible for:
Selecting qualified investigators
Providing the investigators with the information they need to conduct an investigation properly
Ensuring proper monitoring of the investigation
>Maintaining an effective IND with respect to the investigations.
Ensuring that the investigation is conducted in accordance with the general investigational plan and protocols
contained in the IND
Ensuring that the FDA and all participating investigators are promptly informed of significant new adverse
effects or risks with respect to the drug
Principal Investigator (PI) :
The PI is the individual who conducts, supervises and is responsible for all aspects of a clinical trial.
Independent Ethics Committee (IEC) or Institutional Review Board (IRB) or Ethics Committee (EC)
An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects. It is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans.
Contact Research Organisation (CRO)
CRO is a company or organization contracted by a pharmaceutical, medical device, or biotechnology company (called a clinical trial sponsor) to assume various aspects of the clinical research process (i.e., to conduct clinical research trials on behalf of the sponsor)
Clinical Research Associate (CRA)
The monitor/CRA is the principal communication link between the sponsor and the investigator and is appointed by the sponsor
Site Management Organization (SMO)
A Site Management Organization (SMO) is an organization that provides clinical trial related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company or a clinical site.
Clinical Research Co-ordinator (CRC)
Responsible for coordinating all aspects of the clinical trial and day to day operations of the research program.