What information must sponsors provide to potential investigators?

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The main point is that sponsors must provide potential investigators with both the protocol and an up-to-date Investigator's Brochure. The protocol lays out exactly how the trial will be conducted: its design, objectives, endpoints, eligibility criteria, treatment regimens, and the schedule of procedures. The Investigator's Brochure compiles all relevant information about the investigational product’s safety and prior data—nonclinical and clinical findings, known risks, dosing guidance, and study results—so the investigator can assess risks and decide whether to participate. Together, these documents give a complete picture needed to evaluate feasibility, safety, and compliance, and they support ethical and regulatory review. Providing sponsor financial statements isn’t part of what must be shared with potential investigators in this context.