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Acronym for Research Terms

This acronym list is designed to help you, the consumer, become familiar with common terms used in clinical trials.

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700U: Statement of Economic Interest
AAHRPP: Association for the Accreditation of Human Research Protections Programs
(NIH funds both regional centers and a national center: http://www.nattc.org/
ACRP: Association of Clinical Research Professionals
ADR: Adverse Drug Reaction
AE: Adverse Event
AMA: American Medical Association
BID: Twice Daily
BIND: Biological IND
CAP: College of American Pathologists
CBCTN: Community Based Clinical Trials Network
CBER: Center for Biologics Evaluation and Research (FDA)
CCRA: Certified Clinical Research Associate (ACRP)
CCRC: Certified Clinical Research Coordinator (ACRP)
CCRP: Certified Clinical Research Professional (SoCRA)
CDA: Confidential Disclosure Agreement
CDC: Center for Disease Control
CDER: Center for Drug Evaluation and Research (FDA)
CDRH: Center for Devices and Radiological Health (FDA)
CE: Covered Entity
CF: Consent Form
CFR: Code of Federal Regulations
CLIA: Clinical Laboratory Improvement Amendments
CME: Continuing Medical Education
COC: Certificate of Confidentiality
COI: Conflict of Interest
CP: Compliance Program (FDA)
CR: Common Rule
CRA: Clinical Research Associate
CRC: Clinical Research Coordinator
CRF: Case Report Form
CRO: Clinical Research Organization/Contract Research Organization
CS: Clinically Significant
CSA: Clinical Service Agreement
CT: Clinical Trial
CTA: Clinical Trial Agreement
CTSC: Clinical and Translational Science Center
CV: Curriculum Vitae
DCF: Data Correction Form / Data Clarification Form
DEA: Drug Enforcement Agency (law enforcement division of FDA)
DHHS: Department of Health and Human Services (replaced DHEW)
DIA: Drug Information Association
DMC: Data Monitoring Committee
DOS: Description of Study
DSMB: Data Safety Monitoring Board
EAB: Ethical Advisory Board (similar to IRB, used by other nations)
ECOG: Eastern Co-operative Oncology Group (This is the largest multi-center group doing cancer clinical trials: http://ecog.dfci.harvard.edu/
EDC: Electronic Data Capture
FDA: Food and Drug Administration
FDA-1572: FDA Form for New Drug Application
FDA-482: Notice of Inspection
FDA-483: Notice of Adverse Findings in an Inspection
FDA-SRS: Spontaneous Reporting System of the FDA
FDCA: Food, Drug, and Cosmetic Act
FOIA: Freedom of Information Act
FTC: Federal Trade Commission
FWA: Federal Wide Assurance
GCP: Good Clinical Practice
GDA: Global Disclosure Agreement
GLP: Good Laboratory Practice
GMP: Good Manufacturing Practice
GOG: Gynecologic Oncology Group
HDE: Humanitarian Device Exemption http://www.fda.gov/orphan/
HHS: Health and Human Services (Department of)
HIPAA: Health Insurance Portability and Accountability Act
HMO: Health Maintenance Organization
HPA: Human Protections Administrator
HRP: Human Research Protections
HSR: Health Services Research
HUD: Humanitarian Use Device
IACUC: Institutional Animal Care and Use Committee: http://www.iacuc.org/
IB: Investigator's Brochure
IBC: Institutional Biohazard Committee
ICD-9: International Classification of Disease Codes, 9th revision
ICD-9-CM: International Classification of Disease Codes, 9th revision-Clinical Modification
ICF: Individual Consent Form or Institutional Consent Form
ICH: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals
IDB: Investigational Drug Brochure
IDE: Investigational Device Exemption
IDS: Investigational Drug Service (pharmacy)
IEC: Institutional Ethics Committee/Independent Ethics Committee
IMV: Interim Monitoring Visit
INAD: Investigational New Animal Drug (FDA)
IND: Investigational New Drug
IRB: Institutional Review Board
JCAHO: Joint Commission on Accreditation of Healthcare Organizations
JIT: Just in Time (procedure)
LCME: Liaison Committee for Medical Education (This is the American Assoc. of Medical Colleges accrediting authority for U.S. programs leading to the M.D. degree)
LOA: Letter of Agreement
LTF: Lost to follow-up

MDR: Medical Device Reporting
MOU: Memoranda of Understanding
MPA: Multiple Projects Assurance
MRA: Medical Research Associate
MSO: Medical Staff Office
NAI: No Action Indication (most favorable post-FDA inspection classification)
NAIM: National Association of IRB Managers
NBAC: National Bioethics Advisory Commission
NCI: National Cancer Institute
NCPHSBBR: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
NCQA: National Committee for Quality Assurance
(Relevant because of their VA IRB accreditation program: http://www.ncqa.org/communications/news/vahrpaplaunch.htm
NCS: Not Clinically Significant
NDA: New Drug Application
NHLBI: National Heart, Lung, and Blood Institute
NHRPAC: National Human Research Protections Advisory Committee
NIA: Nonaffiliated Investigator Agreement
NIAID: National Institute of Allergy and Infectious Diseases
NIH: National Institute of Health
NIMH: National Institute of Mental Health
NKA: No Known Allergies
NRMI: National Registry of Myocardial Infarction
NSR: Non significant Risk
OAI: Official Action Indicated (serious post-FDA inspection classification)
OHRP: Office of Human Research Protections (formerly OPRR)
OPRR: Office of Protection from Research Risks
ORA: Office of Regulatory Affairs
ORCA: Office of Research Compliance & Assurance
ORI: Office of Research Integrity
OSHA: Occupational Safety and Health Administration
OTC: Over-the-counter (non-prescription drugs)
OVCR:Office of the Vice Chancellor for Research
PCC: Poison Control Center
PD: Pharmacodynamics
PDQ: Physician's Data Query (NCI sponsored cancer trial registry)
PDR: Physician's Desk Reference
PE: Physical Examination
PHI: Private Healthcare Information/Public Health Information/Protected Health Info.
PHS: Public Health Service (USPHS United States Public Health Service)
PI: Principal Investigator
PK: Pharmacokinetics
PLA: Product License Application (when seeking commercialization of a biologic)
PMA: Pre Market Approval
PO: By Mouth
POG: Pediatric Oncology Group
PPE: Personal Protective Equipment
PPI: Patient Package Inserts
PPO: Preferred Provider Organization
PRIMR: Public Responsibility in Medicine and Research
PRN: As Needed
QA: Quality Assurance
QC: Quality Control
QD: Every day
QI: Quality Improvement
QID: Four Times a Day
QOL: Quality of Life
R&D: Research and Development
RAPS: Regulatory Affairs Professionals Society http://www.ncqa.org/communications/news/vahrpaplaunch.htm
RCO: Regulatory Compliance Officer
RCR: Responsible Conduct of Research
RCT: Randomized Control Trial
RDE: Remote Data Entry
REB: Research Ethics Board
RL: Regulatory Letter (post-FDA audit letter)
RTOG: Radiation Therapy Oncology Group www.rtog.org
Rx.: Prescription
SAE: Serious Adverse Events
SAP: Suspect Adverse Reaction
SC: Study Coordinator
SD: Source Document
SIV: Site Initiation Visit
SMO: Site Management Organization
SoCRA: Society of Clinical Research Associates
SOM: School of Medicine
SOP: Standard Operating Procedure
SPA: Single Project Assurance
SR: Safety Report/Significant Risk
SRA: Staff Research Associate
SRO: Sponsored Research Office
SWOG: South West Oncology Group (Another NIIH/NCI supported multi-center cancer clinical trials group: www.swog.org
TID: Three Times a Day
UNK: Unknown
USP: U.S. Pharmacopeia
VA: Veteran's Affairs
VAI: Voluntary Action Indicated (post-FDA audit inspection classification)
VPR: Vice President for Research
VS: Vital Signs
WHO: World Health Organization
WL: Warning Letter (most serious of post-FDA audit letter, demands immediate action within 15 days)
WMA: World Medical Association

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