PhEAST documents

This amendment introduces that participants in the PhEAST trial may need additional chest X-Rays performed, if they are randomised to the PES treatment.
This has been been given radiation assurance by the HRA, having had a CRE and an MPE review the new documents to ensure the correct risk assessment statements are in place.
Further to this, this amendment introduces the collection of protocol deviations, and some additional sentences for clarifcation regarding threshold levels, and the use of catheters.

Trial documents


SA-04-22	This amendment introduces that participants in the PhEAST trial may need additional chest X-Rays performed, if they are randomised to the PES treatment. This has been been given radiation assurance by the HRA, having had a CRE and an MPE review the new documents to ensure the correct risk assessment statements are in place. Further to this, this amendment introduces the collection of protocol deviations, and some additional sentences for clarifcation regarding threshold levels, and the use of catheters. 21 EE 0252 304658 Favourable opinion of a substantial amendment.pdf 304658 SA 04 22.pdf IRAS 304658 SA 04 22 Radiation Assurance Research Exposure Form MPE CRE 07-09-2022.pdf IRAS Project ID 304658. HRA and HCRW Approval for the Amendment.pdf