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21-Dec-2022

100 Clinical Research Acronyms

100 Clinical Research Acronyms

Summary

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.
  • Author Company: PharmiWeb.Jobs
  • Author Name: Lucy Walters
  • Author Email: Lucy.Walters@pharmiweb.com
  • Author Website: https://www.pharmiweb.jobs/
Editor: Lucy Walters Last Updated: 27-Jan-2023

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.