Acronyms and Definitions

 

  1. AE – Adverse Event
  2. AME – Amendment; amendments are completed in eResearch in order to modify an already approved project
  3. CFR – Code of Federal Regulations
  4. COI – Conflict of Interest
  5. Co-I – Co-Investigator
  6. DSMP – Data and Safety Monitoring Plan; this Plan may utilize a Data and Safety Monitoring Board (DSMB)
  7. FDA – Food and Drug Administration
  8. FWA – Federal-Wide Assurance
  9. eRPM – eResearch Proposal Management 
  10. eRRM – eResearch Regulatory Management
  11. GCP – Good Clinical Practices
  12. ICD or ICF – Informed Consent Document or Informed Consent Form
  13. IDE – Investigational Device Exemption
  14. IND – Investigational New Drug
  15. IRBMED – Collectively, the five Institutional Review Boards (IRBs) at UM Medical School
  16. HIPAA – Health Insurance Portability Assurance and Accountability Act (45 CFR 164); HIPAA is enforced by the Office of Civil Rights (OCR)
  17. HHS – Department of Health and Human Services; also DHHS.
  18. HUM Number or HUM #  – The number assigned to project applications through eResearch
  19. OHRP – Office of Human Research Protections
  20. ORIO – Other Reportable Information or Occurrence; also 
  21. OVPR – Office of the Vice President for Research
  22. PHI – Protected Health Information
  23. PI – Principal Investigator
  24. SCR – Scheduled Continuing Review; SCRs are completed through eResearch and are required to be submitted and approved prior to expiration; also CR
  25. UaP – Unanticipated Problem; this is a shortened form of UPIRSO (Unanticipated Problem Involving Risks to Subjects or Others)

Click here to see a full list of acronyms and definitions

 

 

Update Approved by IRBMED Chairs and Director: October 14, 2011

Website Updated: October 17, 2011

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