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Published byBrent French Modified over 9 years ago
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Study Team Members and Responsibilities Chicken Soup for the Busy Coordinator (April 2010)
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Study Team Members At Site Principal Investigator (PI) Co-Investigator (Co-I) CollaboratorsResearch Manager Clinical Research Coordinator (CRC) Other Research Support Staff Study Pharmacist Laboratory Technician Administrative Staff References: NHG PCR SOP-501-A02
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Principal Investigator (PI) Leader of the study team Is ultimately responsible and accountable for all aspects of the trial Has the authority to delegate responsibilities to individual members Responsible for the coordination of investigators at different institutions participating in a multi-centre study, including but not limited to communication with the DSRB Site Principal Investigator For multi-centre studies within NHG and all institutions under the oversight of NHG DSRB, each institution should have a Site Principal Investigator Is responsible for the conduct of the study in his / her institution Co-Investigator (Co-I)/Sub-Investigator Other clinicians and members of the study team who assist the PI in conducting the trial Is given the authority (by PI) to perform trial-related procedures and make important trial-related decisions References: NHG PCR SOP-501-A02 Team Members and Responsibilities
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Collaborator Individual member of the study team designated by the PI to perform research- related activities; preferred term for research that is not a clinical trial May be engaged in activities not directly involving contact with human subjects, such as biostatistics analysis and study design May be from an external organisation References: NHG PCR SOP-501-A02 Team Members and Responsibilities Research Manager Manager of the research administration in the institution Is responsible for developing and negotiating study budgets and contracts Clinical Research Coordinator (CRC) Needs to have in-depth knowledge of protocol requirements and Good Clinical Practice guidelines Manages all aspects of research Acts as liaison between investigators, DSRB and the sponsors Recruits, enrolls and follow up on patients Ensures proper documentation Reports adverse events
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Team Members and Responsibilities Other Research Support Staff Study Pharmacist - Manages the medications Laboratory Technician – Processes the blood specimens Administrative Staff – Provides administrative support References: NHG PCR SOP-501-A02 Email: crcs@nhg.com.sg Clinical Research Coordinator Society c/o Research & Development Office 6 Commonwealth Lane #04-01/02 GMTI Building Singapore 149547 Email: crcs@nhg.com.sg Clinical Research Coordinator Society c/o Research & Development Office 6 Commonwealth Lane #04-01/02 GMTI Building Singapore 149547 For Feedback or Suggestions for CRCS :
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