Study Team Members and Responsibilities Chicken Soup for the Busy Coordinator (April 2010)

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

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

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

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 Clinical Research Coordinator Society c/o Research & Development Office 6 Commonwealth Lane #04-01/02 GMTI Building Singapore Clinical Research Coordinator Society c/o Research & Development Office 6 Commonwealth Lane #04-01/02 GMTI Building Singapore For Feedback or Suggestions for CRCS :