About Clinical Research >> Multiplayers in Clinical Research
An individual, organization or company (pharmaceutical, device or biotech) that initiates a clinical investigation.
Clinical Research Associate (CRA)::
Interface with investigative site on behalf of sponsor or CRO.
Responsible for overall implementation of trial, oversee progress of trial, global trial communications, reporting to FDA, budget and cost control.
Individual with therapeutic expertise; involved in protocol development, safety reporting, interpretation of data and clinical findings.
Generate data queries to ensure quality of data, maintain ongoing data entry, monitor data analysis and provide reports.
Analysis of data provide reports for data safety monitoring board (DSMB) or Endpoint committee..
Institutional Review Board (IRB)or Independent Ethics Committee (IEC):
A specially constituted board established to protect rights, safety and well being of human subjects by providing review (initial and continuing) and oversight.
Data Safety Monitoring Boards (DSMB):
An independent committee, composed of community representatives and clinical research experts that reviews data while a clinical trial is in progress to ensure that participants are not exposed to undue risk.
Food and Drug Administration (FDA):
The US regulatory authority in charge of review and approval of drug applications (IND/NDA), dissemination of safety information and conducting audits or inspections of any sector of clinical research including sites, sponsors, or IRBs.
Research Subject (Volunteer/Participant):
Individual participating in a clinical trial.
Principal Investigator (PI):
The PI is the individual who conducts, supervises and is responsible for all aspects of a clinical trial.
Other clinicians and members of the study team who assist the PI in conducting the trial.
Clinical Research Coordinator:
Responsible for coordinating all aspects of the clinical trial and day to day operations of the research program.
Investigational pharmacist, clinical research manager, technicians, research assistants, regulatory specialist, recruiters, data coordinators, writers & presenters etc.