What must be provided to show the investigator's qualifications?

• A. A letter of reference from a colleague
• B. A certificate of attendance at a conference
• C. A copy of medical license
• D. Up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or regulatory authorities

Answer: (D)

Investigators must be qualified by education, training, and experience, and the documentation proving this must be current and comprehensive. The best answer is an up-to-date curriculum vitae together with any other relevant documentation requested by the sponsor, the IRB/IEC, and/or regulatory authorities. This combination provides a complete, current picture of the investigator’s credentials, including medical licensure where applicable, relevant GCP training, and prior trial experience. A reference letter or a conference attendance certificate alone does not establish current, protocol-specific qualifications, and a license copy alone may not reflect ongoing training or trial-related experience. The sponsor and oversight bodies may require a range of documents, and providing what is requested allows proper verification of the investigator’s ability to conduct the trial ethically and competently.