Writing the protocol
Over the next few months the CloSed Project team will be focusing on the finalisation of the study Protocol. In the Paris meeting on May 22nd all key components of the Protocol synopsis were discussed and finalised and the foundations for the first draft of the Protocol were laid out. This is now underway and is planned to be ready for the first round of review by the Protocol review team in early July. The final version is likely to be ready by early September.
The next steps to be taken in the set up of the study are:
- The stability testing of the study drugs
- Design of blinding and the randomisation
- Shipment process of the study drugs