| Acronym |
Definition |
| AAHRPP |
Association for the Accreditation of Human Research Protections Programs (NIH funds both regional centers and a national center: http://www.nattc.org/ |
| ACRP |
Association of Clinical Research Professionals |
| ADR |
Adverse Drug Reaction |
| AE |
Adverse Event |
| ARENA |
Applied Research Ethics National Association |
| ATTC |
Addiction Technology Transfer Center |
| CE |
Covered Entity |
| CFR |
Code of Federal Regulations |
| CIM |
Certified IRB Manager |
| CIP |
Certified IRB Professional |
| COC |
Certificate of Confidentiality |
| COI |
Conflict of Interest |
| CPA |
Cooperative Project Assurance |
| CR |
Common Rule |
| CRA |
Clinical Research Associate |
| CRF |
Case Report Form |
| CRO |
Clinical Research Organization/Contract Research Organization |
| CRC |
Clinical Research Coordinator |
| DHEW |
Department of Health, Education and Welfare (no longer exists) |
| DHHS |
Department of Health and Human Services (replaced DHEW) |
| DIA |
Drug Information Association |
| DMC |
Data Monitoring Committee |
| DSMB |
Data Safety Monitoring Board |
| ECOG |
Eastern Co-operative Oncology Group (This is the largest multi-center group doing cancer clinical trials: http://ecog.dfci.harvard.edu/ |
| EQUIC |
Enhancing Quality of Informed Consent |
| FDA |
Food and Drug Administration |
| FWA |
Federal Wide Assurance |
| GCP |
Good Clinical Practice |
| GOG |
Gynecologic Oncology Group |
| HDE |
Humanitarian Device Exemption http://www.fda.gov/orphan/ |
| HIPAA |
Health Insurance Portability and Accountability Act |
| HMO |
Health Maintenance Organization |
| HPA |
Human Protections Administrator |
| HRP |
Human Research Protections |
| HSR |
Health Services Research |
| HUD |
Humanitarian Use Device |
| IACUC |
Institutional Animal Care and Use Committee: http://www.iacuc.org/ |
| IB |
Investigator's Brochure |
| IBC |
Institutional Biohazard Committee |
| ICF |
Individual Consent Form or Institutional Consent Form |
| ICH |
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals |
| IDE |
Investigational Device Exemption |
| IEC |
Institutional Ethics Committee/Independent Ethics Committee |
| IND |
Investigational New Drug |
| IRB |
Institutional Review Board |
| JCAHO |
Joint Commission on Accreditation of Healthcare Organizations |
| JIT |
Just in Time (procedure) |
| LCME |
Liaison Committee for Medical Education (This is the American Assoc. of Medical Colleges accrediting authority for U.S. programs leading to the M.D. degree) |
| LTF |
Subjects Lost to Follow-up Subjects (This is a funding mechanism for funding research scientists run by the International Human Frontier Science Program Organization: www.hfsp.org/how/faq_LTF.htm |
| MPA |
Multiple Projects Assurance |
| MSO |
Medical Staff Office |
| NAIM |
National Association of IRB Managers |
| NCPHSBBR |
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research |
| NBAC |
National Bioethics Advisory Commission |
| NCQA |
National Committee for Quality Assurance |
| NDA |
New Drug Application |
| NIH |
National Institute of Health |
| NHRPAC |
National Human Research Protections Advisory Committee |
| NIA |
Nonaffiliated Investigator Agreement |
| NSR |
Non significant Risk |
| NRMI |
National Registry of Myocardial Infarction |
| OHRP |
Office of Human Research Protections (formerly OPRR) |
| OPRR |
Office of Protection from Research Risks |
| ORA |
Office of Regulatory Affairs |
| ORCA |
Office of Research Compliance & Assurance |
| ORI |
Office of Research Integrity |
| OSHA |
Occupational Safety and Health Administration |
| PI |
Principal Investigator |
| PHI |
Private Healthcare Information/Public Health Information/Protected Health Info. |
| PHS |
Public Health Service (USPHS United States Public Health Service) |
| PMA |
Pre Market Approval |
| POG |
Pediatric Oncology Group |
| PRIMR |
Public Responsibility in Medicine and Research |
| QA |
Quality Assurance |
| QC |
Quality Control |
| QI |
Quality Improvement |
| RAPS |
Regulatory Affairs Professionals Society |
| RCO |
Regulatory Compliance Officer |
| REB |
Research Ethics Board |
| RCT |
Randomized Control Trial |
| RCR |
Responsible Conduct of Research |
| RTOG |
Radiation Therapy Oncology Group www.rtog.org |
| SAE |
Serious Adverse Events |
| SAP |
Suspect Adverse Reaction |
| SMO |
Site Management Organization |
| SOP |
Standard Operating Procedure |
| SPA |
Single Project Assurance |
| SR |
Safety Report/Significant Risk |
| SRO |
Sponsored Research Office |
| SWOG |
South West Oncology Group (Another NIIH/NCI supported multi-center cancer clinical trials group: www.swog.org |
| VA |
Veteran's Affairs |
| VPR |
Vice President for Research |
| WMA |
World Medical Association |