Compliance Statement

CGIRB Statement of Signature Requirement – 16 Dec 2013

To download a copy of CGIRB’s Statement of Signature Requirement:

CGIRB Statement of Signature Requirement

CGIRB Statement of Compliance – 02 Nov 2015

Copernicus Group IRB (CGIRB) is organized and operates in compliance with guidelines for good clinical practice and applicable federal requirements for the protection of human research subjects.

The Federalwide Assurance (FWA) is only required for institutions (legal entities) engaged in federally funded research. CGIRB is an independent IRB that does not receive federal funding and is not engaged in research; therefore, CGIRB does not maintain an FWA number. For sites or sponsors utilizing CGIRB’s services, CGIRB should be listed as a designated IRB on the institution’s FWA.

CGIRB is registered with the Office of Human Research Protections (OHRP) and FDA as IRB00001313

To download a copy of CGIRB’s Statement of Compliance:

CGIRB Compliance Statement

Archived CGIRB Compliance Statements:

CGIRB Part 11 Compliance statement – 11 February 2011

Copernicus Group IRB (CGIRB) utilizes electronic records and electronic signatures in compliance with applicable regulatory requirements, including 21 CFR Part 11 regulations. To download a copy of CGIRB’s Part 11 Compliance Statement:

CGIRB Part 11 Compliance Statement