Regulatory Science Symposium: Special Populations Session 2: Clinical Research Support (CRS) Group (2017)

1. Clinical Research process: Phases of clinical investigative research study include,
   1. Protocol development
   2. Review to activation
   3. Conducting study
   4. Reporting/dissemination
2. Challenges in conducting investigator initiated studies:
   1. Identify available clinical research support resources
   2. Maintain a qualified and on-demand study coordinator pool
   3. Access to expertise in budgeting, biostatistics and recruiting
3. Clinical Research Support (CRS): Single stop access to all available services for the investigator to develop, activate, conduct and report results for clinical trials. The focus is mainly on the investigator-initiated studies and non-cancer trials.
4. CRS group services available for the efficiency of the investigation:
   1. Protocol development and study planning:
      1. Research navigation
      2. Clinical research informatics
      3. Biostatistics core and study design
      4. Recruitment support
      5. Budgeting
      6. Technology transfer
   2. Review to activation
      1. Feasibility review
      2. Scientific review
      3. IRB review, study registration
   3. Study conduct
      1. Recruitment
      2. Study coordinator pool, Clinical Trial Unit (CTU)
      3. Clinical trial management-ENCORE
      4. Data management systems
      5. Coordination of ancillary services like laboratory, pharmacy and radiology.
      6. Study monitoring and closure

Accompanying text created by Priyanka Ramasamy | Regulatory Science Graduate Student Worker | pramasam@usc.edu