Final answer:
The statement is true. The sponsor is responsible for selecting qualified investigators as per ICH E6 Section 5.5 and 21 CFR 312.53, with a focus on ensuring the safety of study participants and integrity of the trial data.
Step-by-step explanation:
True, the responsibility of selecting qualified investigators indeed lies with the sponsor according to ICH E6 Section 5.5 and 21 CFR 312.53. The International Conference on Harmonisation's (ICH) Good Clinical Practice (GCP) guideline, specifically Section 5.5, emphasizes the sponsor's role in ensuring that the investigators are appropriately qualified and either licensed or certified in accordance with applicable regulatory requirements. Similarly, Title 21 of the Code of Federal Regulations (CFR), Part 312.53, also puts the onus on the sponsor to select investigators who are qualified by training and experience as appropriate experts to investigate the drug.
A sponsor's responsibilities include verifying the investigator’s qualifications, providing them with the information they need to conduct the trial properly, and ensuring compliance with the study protocol and regulatory requirements. These provisions are put in place to ensure the safety and rights of study participants, as well as the integrity of the clinical trial data.