Category 1
ALCOA-C
What is Accurate, Legible, Contemporaneous, Original, Attributable, and Complete?
CAPA
What is Corrective and Preventive Action (Plan)?
CRF
What is Case Report Form?
CRO
What is Contract Research Organization?
FDA
What is Food and Drug Administration?
EDC
What is Electronic Data Capture?
GCP
What is Good Clinical Practice?
IB
What is Investigator's Brochure?
IRB
What is Institutional Review Board?
IND
What is Investigational New Drug?
LAR
What is Legally Authorized Representative?
PI
Who is the Principal Investigator?
IDE
What is Investigational Device Exemption?
SAE
What is Serious Adverse Event?
SIV
What is Site Initiation Visit?
SUSAR
What is Suspected Unexpected Serious Adverse Reaction?
eTMF
What is the Electronic Trial Master File?
PRO
What is Patient Reported Outcomes?
DSMB
What is Data Safety Monitoring Board?
CCA
What is Code and Coverage Analysis?
OHRP
What is the Office of Human Research Protection?
ICH
What is International Council for Harmonization?
CFR
What is Code of Federal Regulations?
eCRF
What is Electronic Case Report Form?
BAP
What is Biospecimen Accessioning and Processing?