CopernicusGroup.com
Title
Copernicus Group IRB: An Independent Review Board
Description
Copernicus Group IRB was established in July 1996 as an independent institutional review board (IRB or "Board") and operates in compliance with Federal Regulations governing institutional review boards set forth in 21 CFR, 45 CFR and ICH GCP Guidelines. Copernicus Group IRB is also a member of the Consortium of Independent Review Boards (CIRB), which regularly meets with government regulators to review issues of importance to the protection of human subjects involved in clinical research. Copernicus Group IRB has been inspected by the FDA and in July of 2004, Copernicus Group IRB was awarded full accreditation of our Human Research Protection Program by AAHRPP®, The Association for the Accreditation of Human Research Protection Programs, Inc. CGIRB is registered with OHRP as IRB00001313 which complies with all federal regulations pertaining to the protection of human research subjects.
Copernicus Group IRB is composed of highly qualified individuals dedicated to ensuring that the safety and welfare of research study participants are protected. The Board reviews research protocols, investigators, and subject information and consent forms to ensure compliance with federal regulations and consideration of local concerns. In addition to a simplified submission process, Copernicus Group IRB provides:
Copernicus Group IRB may review studies for a single investigator or serve as a central IRB for multi-center trials involving upwards of several thousand investigators. Additionally, Copernicus Group IRB may function as the IRB of record for studies conducted at hospitals or academic institutions. Go to our forms section for the Transfer of IRB Obligations form or visit the Institutions section of the website for additional information.
Additional Information
Related Domains
- Adverse Events
- Belmont Report
- Bioethics
- Central Irb
- Clinical Trials
- Dsmb
- Data Safety
- Erc
- Ethical Review
- Ethics Committee
- Gcp
- Good Clinical Practice
- Helsinki
- Human Research
- Human Subjects
- Human Trials
- Ich
- Independent Ethics Committee
- Informed Consent
- Institutional Review Board
- Medical Devices
- Medical Ethics
- Medical Research
- Nih
- Ohrp
- Pharmaceutical Research
- Pharmaceutical Trials
- Rcr
- Regulatory Compliance
- Research Ethics
- Research Study
- Sae
- Serious Adverse Event
- Central IRB
- DSMB
- ERC
- GCP
- ICH
- NIH
- OHRP
- RCR
- SAE