What does the term Investigator-Adequate Resources imply?

• A. Providing unlimited funding
• B. Ensuring adequate facilities, staff, and resources to conduct the trial and protect subjects
• C. Focusing only on data quality
• D. Hiring external consultants only

Answer: (B)

Investigator-adequate resources means the investigator has enough facilities, trained staff, equipment, and systems to conduct the trial properly and to protect subjects. This includes suitable space and equipment, qualified personnel, access to medical care for participants, proper drug storage and accountability, and robust processes for data management, monitoring, and handling adverse events. The level of adequacy should fit the trial’s complexity, risk, and enrollment, not require unlimited funding. External consultants can be used when needed, but relying on them exclusively won’t meet the expectation that the investigator maintains the necessary internal resources to run the study. So, it’s about having the right mix of facilities, people, and systems to ensure participant safety and data integrity, not just focusing on one aspect like data quality.