Which records document the qualifications of investigators and sub-investigators?

• A. Curriculum Vitae and/or Other Relevant Documents Evidencing Qualifications of Investigators and Sub-Investigators
• B. Normal Values/Ranges for Medical/Laboratory/Technical Procedures and/or Tests Included in the Protocol
• C. Instructions for Handling of Investigational Products and Trial-Related Materials
• D. Sample of Labels Attached to Investigational Product Containers

Answer: (A)

Documenting who is qualified to conduct the trial is done with curricula vitae and related documents that show education, training, certifications, licenses, and relevant prior trial experience. These records demonstrate that investigators and sub-investigators meet the qualifications required to run the study in accordance with the protocol and GCP. The other record types pertain to interpreting results (normal values for procedures), handling and storage of the investigational product, and product labeling—roles that do not verify personnel qualifications.