Abbreviations and Acronyms
A
AAHRPP: Association for the Accreditation of Human Research Protection Programs
ACH: Arkansas Children’s Hospital
ACHRI: Arkansas Children’s Hospital Research Institute
ACNC: Arkansas Children’s Nutrition Center
AE: adverse event
C
CCR: Committee on Clinical Research
CCTO: Cancer Clinical Trials Office
CFR: Code of Federal Regulations
CIRB: Central Institutional Review Board (NCI)
CITI: Collaborative Institutional Training Initiative
CLARA: Clinical Research Administration system
COG: Children’s Oncology Group
COI: conflict of interest
CR: continuing review
D
DCFS: Division of Children and Family Services (Arkansas DHS)
DLAM: Division of Laboratory Animal Medicine
DOJ: Department of Justice
DSM: Data and Safety Monitor; data and safety monitoring
DSMB: Data and Safety Monitoring Board
DSMC: Data and Safety Monitoring Committee
DSMP: Data and Safety Monitoring Plan
DUA: data use agreement
E
ePHI: Electronic Protected Health Information
EUA: emergency use authorization (of a drug or biologic)
F
FERPA: Family Educational Rights and Privacy Act
FWA: Federalwide Assurance
G
GOG: Gynecologic Oncology Group
H
HDE: Humanitarian Device Exemption
HIPAA: Health Insurance Portability and Accountability Act
HITECH: Health Information Technology for Economic and Clinical Health Act
HRPP: Human Research Protection Program
HUD: Humanitarian Use Device
I
IACUC: Institutional Animal Care and Use Committee
ICF: Informed Consent Form
ICP: Informed Consent Process
ICMJE: International Committee of Medical Journal Editors
IDE: Investigational Device Exemption
IND: Investigational New Drug
IRB: Institutional Review Board
L
LAR: legally authorized representative (in a consent form)
LDS: limited data set
M
MIRT: Myeloma Institute for Research and Therapy
N
NCT: National Clinical Trials (number) [a unique identifier given to a clinical study on ClinicalTrials.gov (NIH)]
NDA: non-disclosure agreement
NICE: New Investigation Consult and Education (ORC review of investigator-initiated studies following IRB approval)
NSR: Non-significant Risk
O
OHRP: Office for Human Research Protections (HHS)
ORC: Office of Research Compliance
ORI: Office of Research Integrity (HHS)
ORSP: Office of Research and Sponsored Programs
P
PCRU: Pediatric Clinical Research Unit (ACH)
PHI: Protected Health Information
PI: principal investigator
POG: Pediatric Oncology Group
PPRU: Pediatric Pharmacology Research Unit (ACH)
PRI: Psychiatric Research Institute
PRIM&R: Public Responsibility in Medicine and Research
PRMC: Protocol Review and Monitoring Committee
R
RCR: responsible conduct of research (ORI)
ReSIN: Research Support Information Network
RPR: review preparatory to research (under the HIPAA Privacy Rule)
RSC: Research Support Center (a.k.a. Office of Research Support)
S
SOP: Standard Operating Procedure
SWOG: Southwest Oncology Group
T
TRI: Translational Research Institute
U
UPIRTSO: unanticipated problems involving risks to subjects and others