I will provide copies of this protocol and all pertinent information to the study personnel under my supervision. I will discuss this material with them and ensure they are fully informed regarding the investigational plan and the conduct of the study, applicable laws, regulations, international standards, and ethical and safety considerations, including 21 CFR Parts 50, 54 and 56, International Conference on Harmonization (ICH) Good Clinical Practices (GCP) Guidelines, and Institutional Review Board (IRB) or Ethics Committee (EC) requirements. _____________________________________ ________________ Country/Clinical Site Date _____________________________________ ________________ Country Coordinator Signature Date _____________________________________ ________________ Country Coordinator Printed Name Date Table of Contents
I will provide copies of this protocol and all pertinent information to the study personnel under my supervision. I will discuss this material with them and ensure they are fully informed regarding the investigational plan and the conduct of the study, applicable laws, regulations, international standards, and ethical and safety considerations, including 21 CFR Parts 50, 54 and 56, International Conference on Harmonization (ICH) Good Clinical Practices (GCP) Guidelines, and Institutional Review Board (IRB) or Ethics Committee (EC) requirements. _____________________________________ ________________ Country/Clinical Site Date _____________________________________ ________________ Country Coordinator Signature Date _____________________________________ ________________ Country Coordinator Printed Name Date Table of Contents
point_protocol_v6_0_tracked_changes_19mar2016.docx