CCRP 무료 덤프문제 온라인 액세스

Which of the following identifies content that should be included in a clinical research protocol?

• A.Standard operating procedures for data collection
• B.Criteria for the selection of an investigator
• C.A summary of findings of nonclinical studies that potentially have clinical significance
• D.IRB/IEC approval and meeting minutes

A coordinator for an ongoing industry-sponsored, multi-site Phase II clinical trial is taking an unexpected, long-term medical absence. The trial site retains coordinator services from an external source to support clinical trial activities. According to the ICH GCP Guideline, which of the following is responsible for implementing procedures to ensure the integrity of the clinical trial-related duties?

• A.The IRB/IEC
• B.The investigator/institution
• C.The external source
• D.The sponsor

A physician wants to conduct research using an approved/marketed cardiac stent for use in the carotid artery, which is not an indication for which the device is approved. In this case, the physician must obtain which of the following?

• A.IRB/IEC approval and an FDA IND
• B.The Office for Human Research Protections (OHRP) and manufacturer approvals
• C.IRB/IEC approval and an FDA IDE
• D.IRB/IEC and manufacturer approval

In accordance with the ICH E2A Guideline, the sponsor must report an adverse event that is life-threatening, unexpected, and associated with the investigational drug to the regulatory authority as soon as possible but no later than how many calendar days after first knowledge of the event?

• A.7 days
• B.1 day
• C.15 days
• D.10 days

A sponsor received a report from an investigator regarding the investigator's use of an investigational device without having obtained informed consent. The sponsor must submit a copy of the report to the FDA within:

• A.1 day
• B.30 working days
• C.10 working days
• D.5 working days