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Article History

Received: 8 February 2017

Accepted: 26 June 2017

First Online: 29 June 2017

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 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 are obtained from each patient before any study-specific procedure takes place. Participation in the study and date of informed consent patient 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 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.

: MGP is a co-inventor on a US Patent covering ¹⁸F–DCFPyL and as such is entitled to a portion of any licensing fees and royalties generated by this technology. This arrangement has been reviewed and approved by the Johns Hopkins University in accordance with its conflict of interest policies. MAG has served as a consultant to Progenics Pharmaceuticals, the licensee of ¹⁸F–DCFPyL. The remaining authors declare no conflict of interest.

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