Which document is used to document the agreement between the investigator and sponsor to the protocol/amendments and the CRF?

Which document is used to document the agreement between the investigator and sponsor to the protocol/amendments and the CRF?

• A. Investigator's Brochure
• B. Information Given to Trial Subject -- Informed Consent Form
• C. Advertisement for Subject Recruitment
• D. Signed Protocol and Amendments if any, and Sample CRF

Answer: (D)

The key idea is that the formal agreement between sponsor and investigator about how the study will be run, including any protocol changes and how data will be collected, is captured in a document that contains the signed protocol and amendments along with a sample CRF. This shows both parties’ consent to the study design and the exact data collection instruments to be used, making it the official reference for the trial’s conduct. This is the best choice because it directly documents the agreement on the protocol (and any amendments) and the CRF—the tools used to record study data. The Investigator’s Brochure focuses on safety and background for investigators, not the contract or data collection instruments. The Informed Consent Form is about obtaining participant consent. An advertisement is for recruitment. The signed protocol and amendments with a sample CRF specifically ties the study design to the data collection method, reflecting the agreement between sponsor and investigator.

The key idea is that the formal agreement between sponsor and investigator about how the study will be run, including any protocol changes and how data will be collected, is captured in a document that contains the signed protocol and amendments along with a sample CRF. This shows both parties’ consent to the study design and the exact data collection instruments to be used, making it the official reference for the trial’s conduct.

This is the best choice because it directly documents the agreement on the protocol (and any amendments) and the CRF—the tools used to record study data. The Investigator’s Brochure focuses on safety and background for investigators, not the contract or data collection instruments. The Informed Consent Form is about obtaining participant consent. An advertisement is for recruitment. The signed protocol and amendments with a sample CRF specifically ties the study design to the data collection method, reflecting the agreement between sponsor and investigator.