| ADE | Adverse Drug Event/Experience |
| AE | Adverse Event |
| CAPA | Corrective Action Preventative Action |
| CDA | Confidentiality Disclosure Agreement |
| CFR | Code of Federal Regulations |
| cGMP | Current Good Manufacturing Practice |
| CIOMS | Council for International Organizations of Medical Science |
| CLIA | Clinical Laboratory Improvement Act |
| CRA | Clinical Research Associate |
| CRC | Clinical Research Coordinator |
| CRF | Case Report Form |
| CRO | Contract Research Organizations |
| CSA/CTA | Clinical Study/Trial Agreement (contract) |
| CSO | Consumer Safety Officer (FDA) |
| CTCAE | Common Terminology Criteria for Adverse Events |
| DHHS | Department of Health and Human Services (or HHS) |
| DSMB | Data Safety and Monitoring Board |
| ERD | Ethical and Religious Directives |
| FDA | Food and Drug Administration |
| GCP | Good Clinical Practice |
| GLP | Good Laboratory Practice |
| GMP | Good Manufacturing Practice |
| IBC | Institutional Biosafety Committee |
| ICF | Informed Consent Form |
| ICH | International Conference on Harmonization |
| ID | Investigational Drug/Device |
| IDE | Investigational Device Exemption |
| IDMC | Independent Data Monitoring Committee |
| IEC | Independent Ethics Committee |
| IND | Investigational New Drug |
| IP | Investigational Product |
| IRB | Institutional Review Board |
| IVD | In Vitro Diagnostic |
| NCI | National Cancer Institute |
| NDA | New Drug Application |
| NIH | National Institutes of Health |
| OBA | Office of Biotechnology Activities (NIH) |
| ODD | Orphan Drug Designation |
| OHRP | Office for Human Research Protections (former OPRR) |
| OPRR | Office for Protection from Research Risks |
| PI | Principal Investigator |
| PMA | Pre-Market Approval (Application) |
| PSV | Pre-Site Visit |
| QA | Quality Assurance |
| QC | Quality Control |
| RAC | Recombinant DNA Advisory Committee (NIH) |
| RCA | Root Cause Analysis |
| RCT | Randomized Control Trial |
| SAE | Serious Adverse Event |
| SD | Source Document |
| SI | Sub-Investigator |
| SIV | Site Initiation Visit |
| SOP | Standard Operating Procedure |
| UAE | Unexpected Adverse Event |
