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