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| Multiplayers in Clinical Research |
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| Sponsor: |
| An individual, organization or company (pharmaceutical, device or biotech) that initiates a clinical investigation. |
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| Clinical Research Associate (CRA): |
| Interface with investigative site on behalf of sponsor or CRO. |
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| Project Manager: |
| Responsible for overall implementation of trial, oversee progress of trial, global trial communications, reporting to FDA, budget and cost control. |
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| Medical Monitor: |
| individual with therapeutic expertise; involved in protocol development, safety reporting, interpretation of data and clinical findings. |
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| Data Manager: |
| generate data queries to ensure quality of data, maintain ongoing data entry, monitor data analysis and provide reports. |
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| Statistician: |
| analysis of data provide reports for data safety monitoring board (DSMB) or Endpoint committee. |
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| 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. |
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| 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. |
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| 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. |
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| Research Subject (Volunteer/Participant): |
| Individual participating in a clinical trial. |
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| Principal Investigator (PI): |
| The PI is the individual who conducts, supervises and is responsible for all aspects of a clinical trial. |
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| Sub-Investigator: |
| Other clinicians and members of the study team who assist the PI in conducting the trial. |
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| Clinical Research Coordinator: |
| Responsible for coordinating all aspects of the clinical trial and day to day operations of the research program. |
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| Others: |
| Investigational pharmacist, clinical research manager, technicians, research assistants, regulatory specialist, recruiters, data coordinators, writers & presenters etc. |
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