The investigator should be aware of and comply with which requirements?

• A. Local guidelines only
• B. GCP and applicable regulatory requirements
• C. The sponsor's internal policies
• D. The investigator's personal preferences

Answer: (B)

In clinical research, investigators must follow the standards that govern both ethical and scientific conduct, along with all regulatory requirements that apply to the trial. This ensures participants’ rights, safety, and well-being and protects the integrity and reliability of the data. Following GCP provides a universal framework for how trials should be designed, conducted, recorded, and reported, while regulatory requirements enforce legal compliance in the specific country or region where the study takes place.

That’s why this option is the best: it emphasizes both GCP and applicable regulatory requirements as the baseline obligations for investigators. Local guidelines alone may not be sufficient, sponsor internal policies guide conduct but cannot override the law or GCP, and personal preferences have no bearing on legally binding obligations.