INFORM-ative
The language level that an ICF should be written?
What is a middle school grade level
A study protocol is the backbone of this future document
What is a clinical study report
The timeframe for which an IB must be updated
What is at least annually
The first step in the lifecycle of a protocol
What is development
Informed consent is the framework of this...
What is the protection of human subjects.
The primary audience of a study protocol
What is the investigator and study site staff
The section of the IB that will get shorter as more clinical data are reported
What is the nonclinical section
The 3 things to keep in mind when writing regulatory documents
What are the intended audience, if a regulatory guidance is available, and if a template is available.
This function at a study site must review and approve an ICF
What is an IRB or IEC
These are defined as the specific aims of a study.
What are objectives
The reason that the IB must be as accurate as possible
What is because it is used as a source document for protocols, CSRs, briefing books, etc.
In the United States, this document (protocol, IB, ICF) is part of the original IND for a product
What is A TRICK QUESTION - Protocol, IB, and ICF are all part of the original IND
This cannot begin without a signed ICF
What is a subject's participation in a study
This trumps a protocol for statistical information
What is a statistical analysis plan
An adverse reaction not included in the IB is considered this...
What is unexpected
These are the quantitative measurements of a study protocol
What are endpoints
Report written by the National Commission for the Protection of Human Subjects in the US as the backbone of the informed consent process.
What is the Belmont Report
This type of global protocol amendment does not need to be reviewed by the appropriate review committee?
What is a non-substantial amendment
The information in the IB is to allow an investigator to do this...
What is make their own risk/benefit assessment of the proposed study.
The ICH guidance that provides the general content for the IB, ICF, and protocol
What is ICH E6