Investigator's Brochure - ANSWER Includes the rationale for investigating the IP, dose and regimen, risk/benefit ratio
Investigator - ANSWER Responsible for IP at a site during a study
Investigator's Brochure - ANSWER Includes the rationale for investigating the IP, dose and regimen,
risk/benefit ratio
Investigator - ANSWER Responsible for IP at a site during a study
Phase I - ANSWER Initial clinical safety studies in humans. May be as few as 10 subjects, often healthy
volunteers, includes PK, ADME and dose escalation studies. Usually open label.
Potentially vulnerable subjects who require special considerations by an IRB/IEC - ANSWER - Medical,
pharmacy, dental and nursing students
- Prisoners
- Serving Military Personnel
Protocol must include - ANSWER Statistical methods to be employed
ICH GCP Requires an investigator to provide the IRB/IEC with: - ANSWER 1. Details of expenses that will
be paid to subjects
2. Significant protocol changes
3. Written explanation if a study is terminated or suspended by the sponsor
During a monitoring visit, the CRA is responsible for: - ANSWER 1. Verifying subject protection
2. Confirming data recorded are verifiable from source documents
3. Ensuring protocol compliance
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