15 Questions
What does the term 'protocol' refer to in the context of the ICH GCP Guideline?
The document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial
What are 'Substantial Amendments' in the context of research protocols?
Changes to the design or methodology of the study, or to background information affecting its scientific value
What is the purpose of 'Non-Substantial Amendments' in research protocols?
To correct errors and update contact points
What is a 'Protocol Deviation/Violation' in the context of clinical trials?
Accidental or unintentional changes to, or non-compliance with the study protocol
Who is responsible for the initiation, management, and/or financing of a clinical trial?
Company
Which type of changes to the protocol or other study documentation are considered as Non-Substantial Amendments?
Updating contacts points
Who is responsible for the initiation, management, and/or financing of a clinical trial?
Sponsor
What type of changes to the protocol or other study documentation are considered as Substantial Amendments?
Changes to the design or methodology of the study
What do 'Protocol Deviation/Violation' refer to in the context of clinical trials?
Accidental changes to the study protocol that do not increase risk
What is the term 'protocol' referred to in the context of the ICH GCP Guideline?
The document that describes the objective, design, methodology, and organization of a trial
What is the primary purpose of Investigator Initiated Studies?
To conduct product performance trials
What is one of the responsibilities of Sponsor Managed Clinical Research?
Conducting safety studies for regulatory approval
What type of trials may be included in Investigator Initiated Studies?
Therapy comparison trials
What is a key focus of Sponsor Managed Clinical Research Additional Trials?
Product performance trials
Who is responsible for designing and initiating Investigator Initiated Studies?
External investigators or institutions
Test your knowledge on protocol preparation, non-substantial amendments, substantial amendments, protocol deviation/violation, and sponsor-related documents.
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