| Abbreviation | Definition |
|---|---|
| AE | Adverse Event |
| CAB | Community Advisory Board |
| CFR | Code of Federal Regulations |
| CRF | Case Report Forms |
| COI | Conflict of Interest |
| CRO | Clinical Research Organization |
| CRS | Clinical Research Site |
| DAIDS | Division of AIDS |
| DRTE | DAIDS Regional Training Event |
| DSMB | Data Safety Monitoring Board |
| DSMP | Data Safety Monitoring Plan |
| EAE | Expedited Adverse Event |
| US FDA | Food and Drug Administration |
| FWA | Federalwide Assurance |
| EC | Ethics Committee |
| GCP | Good Clinical Practices |
| GCLP | Good Clinical Laboratory Practices |
| US DHHS | Department of Health and Human Services |
| HIPAA | Health Insurance Portability and Accountability Act |
| HRPP | Health Research Protections Program |
| HSP | Human Subject Protections |
| IND | Investigational New Drug Application |
| IB | Investigator's Brochure |
| ICH | International conference on Harmonization |
| IO | Institutional Official |
| IoR | Investigator of Record |
| IRB | Institutional Review Board |
| LAR | Legal Authorized Representative |
| LoA | Letter of Amendment |
| MO | Medical Officer |
| NIAID | National Institute of Allergy and Infectious Diseases |
| NIH | National Institutes of Health |
| OCSO | Office of Clinical Site Oversight |
| OHRP | Office for Human Research Protections |
| OPCRO | Office for Policy in Clinical Research Operations |
| ORI | Office of Research integrity |
| PI | Principal Investigator |
| PO | Program Officer |
| PRO | Protocol Registration Office |
| QA | Quality Assurance |
| QI | Quality Improvement |
| RA | Regulatory Authority |
| RSC | Regulatory Support Contract |
| SACHRP | Secretary's Advisory Committee on Human Research Protection |
| SAE | Serious Adverse Event |
| SOP | Standard Operating Procedure |
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