Abbreviations
IRB
What is the Institutional Review Board?
Issued, at least annually, to the IRB by the Investigator on the progress of the study.
What is an Annual Progress Report?
Documents financial information of an investigator.
What is Financial Disclosure form?
The person responsible for conducting a study.
Who is the Principal Investigator?
This is the US Regulation for Electronic Records and Signatures
What is 21 CFR Part 11?
CRF
What is a Case Report Form?
Conducted by the Sponsor or representative at the beginning of the study to train the site on the protocol.
What is a Site (Study) Initiation Visit?
This describes the objectives, design, methodology and statistical considerations of the trial.
What is the protocol?
Person who initiates but does not conduct the study.
Who is the Sponsor?
This is the US Regulation for Informed Consent
What is 21 CFR Part 50?
IDE
What is an Investigational Device Exemption?
Begins with study advertisements, includes the informed consent form and continues until the subject has exited the study.
What is the Informed Consent Process?
This document includes 8 essential and as applicable 6 additional elements of informed consent.
What is an Informed Consent Form (ICF)?
A human who participates in a study.
What is a Subject?
This is the US Regulation for Device studies.
What is 21 CFR Part 812?
CFR
What is the Code of Federal Regulations?
A Serious Adverse Event involving an investigational device that is unexpected and must be reported to IRB and FDA within 10 working days.
What is Unanticipated Adverse Device Effect (UADE)?
This documents the Protocol has been reviewed.
What is a Training Record?
An individual designated by a sponsor to oversee the progress of a study.
What is a Monitor?
In the US this is a Guideline not a Regulation.
What is ICH GCP?
DSMB
What is the Data Safety Monitoring Board?
Study discontinued by sponsor or by withdrawal of IRB or FDA approval before completion.
What is Termination?
Contract between Sponsor and Institution about trial conduct.
What is the Clinical Trial Agreement (CTA)?
A committee of at least 5 people formally designated by an institution to review human research.
What is an Institutional Review Board (IRB)?
This is the US Regulation for Financial Disclosure for Investigators.
What is 21 CFR Part 54