In completing Form FDA 1572, Statement of Investigator, the investigator agrees to:

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The correct choice emphasizes the investigator's responsibility to conduct or supervise the clinical investigation personally. This reflects an essential ethical and procedural requirement in clinical research, ensuring that the investigator has direct oversight of the study's execution. By personally conducting or supervising the investigation, the investigator ensures adherence to the protocol, proper management of the trial participants, integrity of the data collected, and maintains the overall ethical standards required by regulatory bodies.

This direct involvement is crucial because the investigator is primarily accountable for participant safety, compliance with study protocols, and the validity of results. If the investigator merely delegated these responsibilities without direct involvement, the quality and integrity of the data could be compromised, potentially affecting participant safety and the success of the clinical trial.

Other options relate to important aspects of clinical research but do not fulfill the key role defined in Form FDA 1572 as directly as the responsibility to conduct or supervise the investigation. For instance, while maintaining records is critical, there are established timelines for record retention rather than an indefinite requirement. Similarly, adverse event reporting is vital but is part of broader responsibilities and not solely the investigator's agreement. Maintaining a contract with the sponsor is standard practice but does not encapsulate the essential personal involvement that Form FDA 1572 necessitates from the investigator.

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