Institutions

• Development of Human Research Protection Programs
• Integration of HRPP Components
• Consultation for:
  • Conflict of Interest (COI) Committees/COI Policies
  • Institutional Review Boards (IRBs)
  • HIPAA/Privacy Boards
  • Grants Management/Sponsored Programs
  • Research Billing
  • Radioactive Drug Research Committees (RDRCs)
  • Embryonic Stem Cell Oversight Committees (ESCROs)
  • Compliance Oversight Programs
  • Institutional Officials – Enhancing the ethical conduct of research
• Education and Training for Investigators and Administrators
• Develop an Educational and Training Conference
• Compliance Oversight: Review of IRBs or Research Teams
• Export Control
• IACUC

Investigators

• Implementation of Quality Systems for Conduct of Research by Investigators​
• Consultation on Ethical Design of Studies
• Consultation on Interactions with FDA
• Staff Training and Development
• Development of Case Report Forms (CRFs) for Investigator-Initiated Studies
• Drug or Device Accountability
• Monitoring of Studies for Sponsor-Investigators
• Preparation for FDA Audits
• Responses to FDA 483 Reports or Warning Letters

IRBs

• Enhancement of the Quality and Efficiency of IRB Review
• Consultation on Organizational Structure
• Staff Development
• Education and Training
• Evaluation of Compliance with Federal Regulations
• Evaluation or Drafting of Standard Operating Procedures
• Responses to FDA audits of IRBs
• ​Responses to OHRP Compliance Inquiries
• Temp Services for IRB Director & Associate Director Positions

Sponsors

• Medical Writing/Drafting Protocols
• Consultation on Ethical Design of Studies
• Consultation on Interacting with FDA
• Development of Case Report Forms
• Assessment and Development of New Sites
• Site Initiation Visits for Investigators
• Education and Training of Investigators/GCP Training
• Enhancing Capture of Data and Endpoints
• Site Monitoring
• Preparation for Audit and Clean-up of Data