CCRP Abbreviations & Word Scramble

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Question	Answer
ADE	adverse drug event
ADR	adverse drug reaction
AE	adverse event
AERS	adverse event reporting system
ALCOA	attributable, legible, contemporaneous, original, accurate
BIMO	bioresearch monitoring program
CAPA	corrective action preventative action
CBER	Center for Biologics Evaluation + Research
CCRP	certified clinical research professional
CDER	Center for Drugs Evaluation + Research
CDRH	Center for Devices and Radiological Health
CFR	Code of Federal Regulations
CRA	Clinical Research Associate
CRC	Clinical Research Coordinator
CRF	case report form
CRO	contract research organization
CTA	clinical trial agreement
CTCAE	common terminology criteria for adverse events
CTMS	clinical trial management system
CV	curriculum vitae
DHHS	Department of Health and Human Services
DOD	Department of Defense
DLT	doses limiting toxicities
DSMB	Data Safety Monitoring Board
FDA	The Food and Drug Administration
FWA	Federal-wide assurance
GCP	good clinical practice
GMP	good manufacturing practice
HIPAA	Health insurance portability and accountability act
HSP	human subject protection
IB	Investigator's Brochure
ICF	informed consent form
ICH	International Conference on Harmonization
IDE	Investigational Drug Exemption
IEC	Institutional Ethics Committee
IND	Investigational New Drug (Application)
IRB	Institutional Review Board
IM	intramuscular
IP	Investigational Product
IV	intravenous
MDR	manufacturing data report/medical doctor research
MTD	maximum tolerated dose
NCI	National Cancer Institute
NIH	National Institute of Health
NDA	New Drug Application
NSR	non-significant risk
OAI	official action indicated
OHRP	Office of Human Research and Protection
PD	protocol devation/pharmacodynamic
PI	Principal Investigator
PK	pharmacokinetic
PMA	premarket approval
PMS	post marketing study
QA	Quality Assurance
QC	Quality Control
RCT	randomized clinical trial
SADR	serious adverse drug reaction
SAE	serious adverse event
SC	study coordinator
SD	source document/study drug
SDV	source data verification
SMO	site management organization
SOP	Standard Operating Procedures
SR	significant risk
SoCRA	the Society of Clinical Research Associates
WHO	World Health Organization
WL	warning letter
WMA	World Medical Association
RBM	risk-based monitoring
TMF	trial master file

Created by: ashleysblair