Access Keys:
Skip to content (Access Key - 0)

Clinical Research Operations

Office of Regulatory Affairs

Mission

The Office of Regulatory Affairs provides regulatory support throughout the protocol lifecyle to CCR investigators and their research team.

What services we provide
  • Regulatory coordination
  • Protocol writing
  • SRC/IRB submissions
  • IND management including FDA submissions
  • Pharmacovigilance
  • Submissions to other regulatory bodies
  • Minutes for CCR meetings
  • Administer Scientific Review
Resources

ACMG List of Incidental Findings

FAQs for Submissions Procedures

FDA Forms

FDA Guidance Documents

ICH and OHRP Guidance

NCI Central IRB

NIH Clinical Center Bylaws

NH Data Analysis Guide IPAC

OHSRP Guidance Documents

Points to Consider for International Research

Walter Reed National Military Medical Center (WRNMMC) Reliance Agreement

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.