Regulatory Support and Knowledge

1. The Rockefeller UniversityCenter for Clinical and Translational ScienceRegulatory Support and KnowledgeRhonda G. Kost, MD, Clinical Research OfficerDonna Brassil, RN, Clinical Research Facilitator

2. Regulatory Support and Knowledge Objectives: • Achieve GCP across all research at the Center • Support investigators with specialized staff • Provide integrated infrastructure to support research • Expand educational initiatives • Sustain Research Subject Advocacy functions

3. Regulatory Support and Knowledge Resources • Clinical and Translational Research Facilitation Office • Clinical Research Support Office • Information Technology – iRIS project • Protection of Human Subjects, Regulatory Issues, and GCP Subcommittee to the ACCTS

4. Protocol Development and Design Clinical /Translational Research Facilitation Office • Core of CCRC certified NP/coordinators • Supports new, inexperienced or under-resourced investigators in GCP conduct of studies • Guides investigator through protocol design, writing, ICF, workflow, utilization, CRF creation • Guides consultations with Nursing, Bio-nutrition, Biostatistics, Research Pharmacy, others

5. Protocol Development and Design The Clinical Research Support Office • Certified Monitors, Clinical Research Officer, Research Subject Advocate, Recruitment Specialist, IND Specialist. • Supports protocol development, research safety, integrity. • DSMP/DSMB assistance and review • Program of IND Assistance (PIA) • Recruitment and advertising support • Research Subject Advocacy and ethics • IRB liaison

6. Protocol Conduct • Clinical and Translational Research Facilitation Office • Provide coordinator support • Study conduct • Research Documentation • Data entry support

7. Protocol Conduct • Clinical Research Support Office • Post approval Monitoring Program • Audits: • Monitoring • Human Subjects investigations • Problem solving

8. Infrastructure - existing • Webpages – IRB, Hospital, Clinical Research Support Office, CCTS • Program of IND Assistance webpage • On-line protocol submission system • On-line protocol document management • Client-based recruitment/screening database • Limited IRB database

9. Infrastructure –Customized iRIS for 2008 • On-line protocol writing/submission within IRB database • Electronic IRB • On-line review • Document management system for archiving • Protocol electronically integrated to populate: • Study schedule of events • Nursing/coordinator workflow • Study CRFs • Patient and clinic visit schedule • Study Management module • Provides structure for GCP compliance

10. Infrastructure –Customized iRIS for 2008 • Study Management module captures: • Enrollment, accrual, attrition, retention • Study endpoints • Adverse event logs and reporting • Study deviation/violations and reporting • Data collation for Continuing Review reports • Center utilization reports and some metrics • Transparent for audit purposes • Integrated Screening and Recruitment Database

11. Education • Collaborative across departments • CITI program, HSPT, GCP • One-on-one orientation of all new research staff • One-on-one protocol/audit specific training • Weekly brown bag GCP sessions • Half and Full Day Training seminars in GCP, Plain Language, etc • Written policies standardize activities

12. Summary • Barriers • Delays in hiring • Complexity of systems development • Successes • Core of coordinators concept • Incorporation of GCP into iRIS • Post approval monitoring program • IND Program • Recruitment Team