Protocol Support Office

Mission

The Protocol Support Office provides regulatory support throughout the protocol lifecycle to CCR investigators and their research teams.

What services we provide

• Regulatory coordination
• Protocol writing
• SRC/IRB submissions
• Submissions to other regulatory bodies such as IBC, RSC, OSHRP
• Minutes for CCR meetings
• Administer Scientific Review
• Safety Monitoring Committee submissions

Resources

ACMG List of Incidental Findings

FAQs for Submissions Procedures

FAQs for FDAAA

ICH and OHRP Guidance

NCI Registration and Credential Repository (RCR)

NIH Clinical Center Bylaws

NIH Policy on Registration and Results Submission of NIH-Funded Clinical Trials

Points to Consider for International Research

Walter Reed National Military Medical Center (WRNMMC) Reliance Agreement

Protocol Templates and Forms

NCI CCR SMC Charter

Who we are -- Contact Information

Protocol Support Office general mailbox: nciprotocolsupportoffice@mail.nih.gov

CCR Safety mailbox: CCRSafety@mail.nih.gov

For more contact information, click here.