Document is current

Article History

Received: 12 June 2018

Accepted: 6 June 2019

First Online: 13 June 2019

Ethics approval and consent to participate

: This study will be carried out in compliance with the protocol and Good Clinical Practice, as described in: ICH Harmonized Tripartite Guidelines for Good Clinical Practice 1996; US 21 Code of Federal Regulations dealing with clinical studies (including parts 50 and 56 concerning informed consent and Institutional Review Board (IRB) regulations); and the Declaration of Helsinki, concerning medical research in humans (Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects, Helsinki 1964, amended Tokyo 1975, Venice 1983, Hong Kong 1989, Somerset West 1996). The investigator agrees to adhere to the instructions and procedures described in it and thereby to adhere to the principles of Good Clinical Practice. Written informed consent is obtained from each patient before any study-specific procedure takes place. Participation in the study and date of informed consent are being documented appropriately in each patient’s files. A Data Monitoring Committee is in place to monitor the trial. Data and safety monitoring oversight is conducted by the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins Safety Monitoring Committee. Per the SKCCC at Johns Hopkins Safety Monitoring plan, the CRO AQ will forward summaries of all monitoring reports to the Safety Monitoring Committee for review.

: Not applicable.

: The authors declare that they have no competing interests.