Before entering an agreement with an investigator, what should the sponsor provide?

• A. Protocol and up-to-date Investigator's Brochure
• B. Informed Consent Form
• C. Monitoring Plan
• D. Statistical Analysis Plan

Answer: (D)

The key idea is that sponsors must share how the data will be analyzed before finalizing an agreement with the investigator. The Statistical Analysis Plan lays out the exact methods for analyzing the study data: which endpoints will be analyzed, which populations (e.g., intent-to-treat) will be included, how missing data will be handled, interim analyses if any, and how results will be summarized and interpreted. Providing this plan up front ensures the investigator understands what analyses are planned, what data must be collected to support those analyses, and how the study’s conclusions will be drawn. This helps assess feasibility, align on regulatory expectations, and prevent post hoc changes to analyses that could bias results. While the protocol, Investigator’s Brochure, and consent forms are essential startup documents, the Statistical Analysis Plan specifically communicates the planned analytical approach that drives the trial’s conclusions, making it the most critical document to share during agreement negotiations.