100 Clinical Research Acronyms

If you’re just starting your career in Clinical Research, trying to understand all of the acronyms used in various roles can be confusing. To help, we’ve put together this list of 100 acronyms used in Clinical Research for you to know.

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1. ADR: Adverse Drug Reaction
2. AE: Adverse Event
3. ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate
4. API: Active Pharmaceutical Ingredient / Application Program Interface
5. ARO: Academic Research Organisation
6. BA / BE: Bioavailability / Bioequivalence
7. BLA: Biological Licensing Application
8. BSM: Biospecimen Management
9. CA: Competent Authority
10. CAPA: Corrective and Preventive Action
11. CCEA: Complete, Consistent, Enduring, Available
12. CCTO / CTO: Centralised Clinical Trials Office / Clinical Trials Office
13. CDM: Clinical Data Management
14. CDMS: Clinical Data Management System
15. CDP: Clinical Development Plan
16. CDS: Clinical Data System
17. CDUS: Clinical Data Update System
18. CI: Confidence Interval
19. CMO: Contract Manufacturing Organisation
20. CNT: Consented but Not Treated
21. CPM: Clinical Project Manager
22. CRA: Clinical Research Associate
23. CRC: Clinical Research Coordinator
24. CRF: Case Report Form
25. CRMS: Clinical Research Management System
26. CRO: Clinical Research Organisation / Contract Research Organisation
27. CSR: Clinical Study Report
28. CSO: Contract Safety Organisation
29. CTA: Clinical Trial Authorisation / Agreement
30. CTCAE: Common Terminology Criteria for Adverse Events
31. CTMS: Clinical Trial Management System
32. CTRP: Clinical Trials Reporting Program
33. DDI: Drug-Drug Interaction
34. DM: Data Manager
35. DMC: Data Monitoring Committee
36. DMP: Data Management Plan
37. DSMB: Data Safety Monitoring Board
38. EC: Ethics Committee
39. eCOA: Electronic Clinical Outcome Assessment
40. eCRF: Electronic Case Report Form
41. EDC: Electronic Data Capture
42. EHR: Electronic Health Record
43. EMR: Electronic Medical Record
44. ePRO: Electronic Patient-Reported Outcomes
45. eTMF: Electronic Trial Master File
46. FAIR: Findable, Accessible, Interoperable, Reusable
47. FDA: Food and Drug Administration
48. FIH: First In Human
49. GCP: Good Clinical Practice
50. GDP: Good Documentation Practice
51. GDPR: General Data Protection Regulation
52. GLP: Good Laboratory Practice
53. GMP: Good Manufacturing Practice
54. GVP: Good Pharmacovigilance Practice
55. ICF: Informed Consent Form
56. IDE: Investigational Device Exemptions
57. IEC: Independent Ethics Committee
58. IHCRA: In House Clinical Research Associate
59. IMP: Investigational Medical Product
60. IMPD: Investigational Medicinal Product Dossier (EUDRA)
61. IND: Investigational New Drug Application (US FDA)
62. IRB: Institutional Review Board
63. IP: Investigational Product
64. ITT: Intent to Treat
65. LTFU: Long Term Follow Up
66. MAA: Marketing Authorisation Application (EUDRA)
67. MAD: Multiple Ascending Dose
68. MRN: Medical Record Number
69. MP: Monitoring Plan
70. NDA: New Drug Application (US FDA)
71. NHV: Normal Healthy Volunteer
72. OSR: Outside Safety Report
73. PC: Protocol Coordinator
74. PD: Protocol Director
75. PHI: Protected Health Information
76. PI: Principal Investigator
77. PRMS: Protocol Review and Monitoring System
78. PRO: Patient-reported Outcomes
79. QC: Quality Control
80. QCT: Qualifying Clinical Trial
81. QMS: Quality Management System
82. QOL: Quality of Life
83. RBM: Risk-based Monitoring
84. REC: Research Ethics Committee
85. SAD: Single Ascending Dose
86. SAE: Serious Adverse Event
87. SAP: Statistical Analysis Plan
88. SC: Study Coordinator
89. SDV: Source Document (Data) Verification
90. SIF: Site Investigator File
91. SOC: Standard of Care
92. SOE: Schedule of Events
93. SOP: Standard Operating Procedures
94. SRB: Scientific Review Board
95. SRC: Scientific Review Committee
96. SUSAR: Suspected Unexpected Serious Adverse Reaction
97. TMF: Trial Master File
98. TMO: Trial Management Organisation
99. UADE: Unanticipated Adverse Device Effect
100. UADR: Unexpected Adverse Drug Reaction

Additional Resources

If you’re looking for your first role in Clinical Research, take a look at some of our recent articles below for more advice on navigating this ever-changing field. 

• What Does a Clinical Data Manager do?
• What Does a Study Start-Up Specialist do?
• 8 Reasons to Choose a Career in Clinical Research
• Average UK Clinical Research Salaries in 2022
• 10 Clinical Research Career Paths

*Article updated March 2024.