Page 14 - eBook Version 8 Book 1 of 2 JUL 2022

Acronyms
AE Adverse Event
AR Adverse Reaction
CMO Contracts Management Order
COI Conflict of Interest
CR Continuing Review
CRA Clinical Research Associate
CRC Clinical Research Coordinator
CRC/RN Clinical Research Coordinator/Registered Nurse
CRF Case Report Form
CTA Clinical Trial Agreement
CTCA Clinical Trial Coverage Analysis
DOA Delegation of Authority Log
DUA Data Use Agreement
eCRF Electronic Case Report Form
EDC Electronic Data Capture
EMR Electronic Medical Record
EOS End of Study
EOT End of Treatment
FDA Food and Drug Administration
FUA Facilities Use Agreement
GCP Good Clinical Practices
GMO Grant Management Order
HIPAA Health Insurance Portability and Accountability Act of 1996
HSP Human Subject Protection RBR Research Billing Review
IB Investigator Brochure
ICF Informed Consent Form
ICH International Conference of Harmonization IDE Investigational Device
IEC International Ethics Committee
IMV Interim Monitoring Visit
IND Investigational New Drug
IP Investigational Product
IRB Institutional Review Board
IRT Interactive Response Technology
IWRS Interactive Web Response System
LI Learning Institute
LOI Letter of Intent
MA Medical Assistant
MOOP Manual of Operating Procedures
MOP Manual of Operations
PD Protocol Deviation
PI Principle Investigator
PK Pharmacokinetics
PV Protocol Violation
PSA Performance Site Approval
SAE Serious Adverse Event
SOA Service Order Agreement
SOP Standard Operating Procedure
SOW Service Order Worksheet