Welcome to the second issue of the NEMO newsletter
This has been another productive and challenging year for the NEMO clinical trial sites. All active recruiting sites now have approval to restart and are looking or have just been granted approvals for protocol version 5.0. This huge achievement would not have been possible without the work of Havinder, Vincent, Ronit, Geraldine and the PIs and study team at each site. I know that each site had individual issues that had to be resolved regarding submissions and approvals and that it is a major “milestone” that all these issues were resolved.
All clinical sites have Competent Authority approvals in place for protocol version 4.0. Some sites have also been granted approvals protocol version 5.0, and the other sites are only waiting for the replies from their national authorities for version 5.0.
Reconciling all this documentation for the Investigator Site Files (ISF) and the Trial Management File (TMF) is a painstaking task for Havinder and Jackie but one completed with their usual throughness
We will hopefully be welcoming Tours and Kings College as active recruiting centres in the near future.