Before the clinical phase of the trial commences, what should be documented?

• A. Recruitment targets
• B. A statement of the trial's budget
• C. That relevant and current scientific information about the investigational product has been provided to the investigator
• D. The final statistical plan

Answer: (C)

Before starting a trial, the investigator must have received up-to-date, relevant scientific information about the investigational product. This is typically provided in the Investigator’s Brochure and includes current data on pharmacology, toxicology, dosing, safety, and any new findings. Having this information ensures the investigator can assess risks and benefits, obtain proper informed consent, and implement appropriate safety monitoring and reporting. Other items like recruitment targets, the final statistical plan, or budget are important for study management but do not fulfill the essential pre-start documentation requirement related to the investigational product’s safety and scientific basis.