ACRONYMS AND DEFINITIONS

 

  1. AAHRPP is the Association for the Accreditation of Human Research Protection Programs
  2. ACCR is the Advisory Council on Clinical Research
  3. ACRP is the Association of Clinical Research Professionals
  4. ADA is the American Dental Association
  5. AE is an Adverse Event
  6. AHRQ is the Agency for Healthcare Research and Quality
  7. AMA is the American Medical Association
  8. AME is an Amendment; amendments are completed in eResearch in order to modify an already approved project
  9. ANDA is an Abbreviated New Drug Application
  10. ARA is an Associate Regulatory Analyst
  11. ARENA is the Applied Research Ethics National Association
  12. Associate Dean is the Medical School Associate Dean for Regulatory Affairs
  13. BEU refers to the Hospital Biomedical Engineering Unit
  14. CareWeb is a web-based clinical patient record that provides rapid access to patient data from a wide variety of clinical systems, including lab, radiology, medical records and others
  15. CDC is the Centers for Disease Control
  16. CFR is the United States Code of Federal Regulations
  17. Chair(s) are the IRBMED Chair, Co-Chair(s), and Vice-Chair(s) of the Board
  18. CIRB is the Central Institutional Review Board
  19. CMS stands for the Centers for Medicare and Medicaid Services
  20. CoC is a Certificate of Confidentiality
  21. COI refers to a conflict of interest, and may consist of a financial conflict of interest or a conflict of commitment; it includes both actual and perceived conflicts of interest
  22. Co-I is a Co-Investigator; see also Sub-I (Sub-Investigator)
  23. Common Rule is the Federal Policy for the Protection of Human Subjects, as set forth in 45 CFR 46, subpart A, and parallel regulations promulgated by agencies such as the Food and Drug Administration (FDA)
  24. Compliance Committee is the committee charged with reviewing and approving compliance matters for the Medical School and Health System
  25. CR is a Continuing Review; CRs are completed through eResearch and are required to be submitted and approved prior to expiration; see also SCR
  26. CRAO is the Clinical Research Calendar Review Analysis Office, formerly the Clinical Research Billing Unit (CRBU)
  27. CRF is a Case Report Form
  28. CTO is the Clinical Trials Office
  29. CTSA is the Clinical and Translational Science Award
  30. CPT Codes or Current Procedural Terminology Codes are the billing code numbers associated with medical procedures
  31. dbGaP is the database of Genotypes and Phenotypes
  32. Dean is the Dean of the Medical School
  33. DHHS is the Federal Department of Health and Human Services; see also HHS
  34. DOD Department of Defense
  35. DRDA is the Division of Research Development and Administration of the University of Michigan Office of the Vice President for Research
  36. DSC is a Data Safety Committee
  37. DSMB is the Data and Safety Monitoring Board
  38. DSMP is a Data and Safety Monitoring Plan
  39. EFIC means an Exception from Informed Consent concerning FDA-regulated activity as set forth in 21 CFR 50.24
  40. eRAM is the eResearch Animal Management system.
  41. eRRM is the eResearch Regulatory Management, the web-based system that centralizes the review and approval process for Human Subjects Research Applications and IBC Biosafety Registrations
  42. eRPM is the eResearch Proposal Management, used to accommodate the electronic routing, approval, and submission of funding proposals to external sponsors, including Grants.gov
  43. eThority is a tool to assist researchers with one point of data entry for building a clinical research budget and billing calendar and tracking your subject enrollment
  44. EVPMA is the Executive Vice President for Medical Affairs
  45. FDA is the Food and Drug Administration
  46. FOIA is the Freedom of Information Act
  47. FWA refers to a Federal-Wide Assurance
  48. GCP is Good Clinical Practice
  49. GMP is Good Manufacturing Practice
  50. GINA is the Genetic Information Nondiscrimination Act of 2008
  51. GWAS is the Genome-Wide Association Studies
  52. HDE is a Humanitarian Device Exemption
  53. HHS is the U.S. Health and Human Services; see also DHHS
  54. HIPAA is the Health Insurance Portability and Accountability Act of 1996, as amended, and privacy regulations promulgated pursuant to the Act
  55. HITECH is the Health Information Technology for Economic & Clinical Health
  56. hPSCRO is the Human Pluripotent Stem Cell Research Oversight Committee
  57. HRPP is the University of Michigan’s Human Research Protection Program
  58. HUD is a Humanitarian Use Device
  59. HUM Number or HUM # is the number assigned to project applications through eResearch
  60. Human Subject means:
    • OHRP: “A living individual about whom an investigation conducting research obtains (1) Data through intervention or interaction with the individual or (2) identifiable private information.” 45 CFR 46.102 (f)
    • FDA: “An individual who is or becomes a participant in research, either as a recipient of the test article or as a control.  A subject may be either a healthy human or a patient.”   21 CFR 50.3 (g) and 21 CFR 56.102 (e)
  61. IAA is the IRB (Institutional) Authorization Agreement
  62. IB is the Investigators Brochure
  63. IBC is the Institutional Biosafety Committee
  64. ICD is an Informed Consent Document; see also ICF
  65. ICD-9 is the numeric code designating a diagnosis.
  66. ICF is an Informed Consent Form; see also ICD
  67. IDE means an approved Investigational Device Exemption
  68. IDS refers to the Investigational Drug Service, which is part of the University of Michigan Hospital and Health Centers
  69. IIA is a Individual Investigator Agreement
  70. IND means an Investigational New Drug application
  71. Individual means a current or former patient of UMHHC or the Medical School’s Faculty Group Practice; or a member of M-CARE, M-CAID, or other health plans issued, administered, or serviced by the Health System
  72. IO is an Institutional Official; see also OVPR
  73. IOM is the Institute of Medicine
  74. IRB is an Institutional Review Board
  75. IRB-HSBS is the Institutional Review Board for Health Sciences and Behavioral Science
  76. IRBMED refers collectively to the University of Michigan Medical School Institutional Review Boards (A1, A2, B1, B2, and C1) for Human Subjects Research
  77. ITS is the Information and Technology Services
  78. JARA is a Junior Associate Regulatory Analyst
  79. LAR is a Legally Authorized Representative, who is an individual, judicial body, or other party authorized under applicable law to consent on behalf of an individual to his/her enrollment and continued participation as a subject in a research project
  80. MCIT is the Medical Center Information Technology
  81. MCRU is the Michigan Clinical Research Unit
  82. Medical School is the University of Michigan Medical School
  83. Medical School Associate Deans for Research and Regulatory Affairs refers to the Senior Associate Dean for Research and the Associate Dean for Regulatory Affairs
  84. MIAP is the MICHR IND/IDE Investigator Assistance Program
  85. MICHR is the Michigan Institute for Clinical and Health Research
  86. Minimal Risk
    • Generally: “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in the daily life or during the performance of routine physical or psychological examinations or tests”  45 CFR 46.102(i)
    • Prisoners:  “Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy person"  45 CFR 46.303(d)
  87. MSIS is the Medical School Information Services
  88. NCI is the National Cancer Institute
  89. NCRC refers to the North Campus Research Complex
  90. NIAAA refers to the National Institute on Alcohol Abuse and Alcoholism
  91. NIDA refers to the National Institute on Drug Abuse
  92. NIH is the National Institutes of Health
  93. NIMH refers to the National Institute of Mental Health
  94. NSR is a Non-significant Risk Device
  95. Non-affiliated Member is a member of a IRB who has no ties to UM, its staff or faculty, usually from the local community (e.g., minister, business person, attorney, teacher, or homemaker).
  96. OBA is the Office of Biotechnology Activities
  97. OHRCR is the Office of Human Research Compliance Review
  98. OHRP is the Department of Health and Human Services Office for Human Research Protections.
  99. OM is the Operations Manual for the Office of the Vice President for Research
  100. OPRR is the Office of Protection from Research Risks, now known as the OHRP
  101. ORIOs are Other Reportable Information or Occurrences
  102. OVPR is the Office of the Vice President for Research of the University of Michigan.  The Vice President for Research is the “institutional official” named in the Single Project or Federal Wide Assurances (FWA)
  103. PEERRS is the Program for Education and Evaluation in Responsible Research and Scholarship
  104. PHI means Protected Health Information (including demographic information) about a patient that (i) is created or received by a health care provider or health plan; (ii) relates to the past, present, or future physical or mental health of the patient; and (iii) identifies the patient or with respect to which there is a reasonable basis to believe it could be used to identify the patient
  105. PHS refers to the Public Health Service
  106. PI is the Principal Investigator conducting research
  107. Privacy Board is the subsection or subcommittee of the IRBMED charged with handling HIPAA matters referred to the IRBMED and in accordance with the Standard Operating Procedures (SOPs)
  108. QA/QI is Quality Assurance/Quality Improvement
  109. RDRC is the Radioactive Drug Research Committee
  110. Research is:
    • OHRP: “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge.” 45 CFR 46.102 (d)
    • FDA: “[A]ny experiment that involves a test article and one or more human subjects [or specimen]…the results of which are intended to be submitted to…FDA… The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for this part.” 21 CFR 56.102 (c)
  111. RRERR is a Routine Research Educational and Regulatory Review conducted by the Office of Human Research Compliance Review (OHRCR)
  112. SARA is a Senior Associate Regulatory Analyst
  113. SAE is a Serious Adverse Event
  114. SCR is a Scheduled Continuing Review; SCRs are completed through eResearch and are required to be submitted and approved prior to expiration; see also CR
  115. Senior Associate Dean is the Medical School Senior Associate Dean for Research
  116. SHUR is the University Subcommittee on the Human Use of Radioisotopes
  117. SMR is a Single Member Review
  118. SOP is a Standard Operating Procedure
  119. SPA is a Single Project Assurance
  120. SPG is the University of Michigan Standard Practice Guide
  121. SR is a Significant Risk Device
  122. SSDI is the Social Security Death Index
  123. STARS refers to Speak to a Regulatory Specialist
  124. Sub-I is a Sub-Investigator; see also Co-I (Co-Investigator)
  125. TPC is the Tissue Procurement Core
  126. UaP/UPIRSO is a Unanticipated Problem Involving Risks to Subjects or Others
  127. UMHHC is the University of Michigan Hospitals and Health Centers
  128. UMHS is the University of Michigan Health System
  129. UMMS is theUniversity of Michigan Medical School
  130. University or UM is the University of Michigan
  131. VA is Veteran’s Affairs
  132. VPR is the Vice President for Research

Click here to see a list of the most commonly used acronyms and definitions.

 

 

Update Approved by IRBMED Chairs and Director: October 14, 2011
Website Updated: October 17, 2011