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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