Podcast
Questions and Answers
What does the term 'protocol' refer to in the context of the ICH GCP Guideline?
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 (correct)
- Changes to the design or methodology of the study, or to background information affecting its scientific value
- Accidental or unintentional changes to, or non-compliance with the study protocol
- Minor changes to the protocol or other study documentation
What are 'Substantial Amendments' in the context of research protocols?
What are 'Substantial Amendments' in the context of research protocols?
- Minor changes to the protocol or other study documentation
- Changes to the design or methodology of the study, or to background information affecting its scientific value (correct)
- Changes that significantly affect the scientific value of the study
- Accidental or unintentional changes to, or non-compliance with the study protocol
What is the purpose of 'Non-Substantial Amendments' in research protocols?
What is the purpose of 'Non-Substantial Amendments' in research protocols?
- To ensure subject's rights, safety, and welfare are not affected
- To make accidental or unintentional changes to the study protocol
- To make changes that significantly affect the scientific value of the study
- To correct errors and update contact points (correct)
What is a 'Protocol Deviation/Violation' in the context of clinical trials?
What is a 'Protocol Deviation/Violation' in the context of clinical trials?
Who is responsible for the initiation, management, and/or financing of a clinical trial?
Who is responsible for the initiation, management, and/or financing of a clinical trial?
Which type of changes to the protocol or other study documentation are considered as Non-Substantial Amendments?
Which type of changes to the protocol or other study documentation are considered as Non-Substantial Amendments?
Who is responsible for the initiation, management, and/or financing of a clinical trial?
Who is responsible for the initiation, management, and/or financing of a clinical trial?
What type of changes to the protocol or other study documentation are considered as Substantial Amendments?
What type of changes to the protocol or other study documentation are considered as Substantial Amendments?
What do 'Protocol Deviation/Violation' refer to in the context of clinical trials?
What do 'Protocol Deviation/Violation' refer to in the context of clinical trials?
What is the term 'protocol' referred to in the context of the ICH GCP Guideline?
What is the term 'protocol' referred to in the context of the ICH GCP Guideline?
What is the primary purpose of Investigator Initiated Studies?
What is the primary purpose of Investigator Initiated Studies?
What is one of the responsibilities of Sponsor Managed Clinical Research?
What is one of the responsibilities of Sponsor Managed Clinical Research?
What type of trials may be included in Investigator Initiated Studies?
What type of trials may be included in Investigator Initiated Studies?
What is a key focus of Sponsor Managed Clinical Research Additional Trials?
What is a key focus of Sponsor Managed Clinical Research Additional Trials?
Who is responsible for designing and initiating Investigator Initiated Studies?
Who is responsible for designing and initiating Investigator Initiated Studies?
