Date Modified

2018-01-14

Period

6/months

Report Summary

Version 2 of the protocol has been amended (version 3) and submitted to ERC University of Colombo for ethical approval on 09.11.2017. Version 3 has not received ethical approval yet. CRO's site initiation visit was completed in early December 2017. CRO's report indicated that the site is ready for enrollment once local ERC approval is available. The same version of protocol has received WIRB, USA approval. Colombo ERC wants to register 3D camera in NMRA, MoH Sri Lanka to be use in the study. An application has been submitted to NMRA for equipment registration. Once NMRA approval is available ERC will approve the version 3. Our planning is to start enrollment of patients by first week of February 2018.

Attached file