Site (Beaumont Hospital) Sign Off:
- Process and SOP (updated Jan 2023) -
Research Studies / Clinical Trials Requiring Site Approval
The Beaumont Hospital Director of Quality and Patient Safety released an updated version of the SOP for Hospital Sign Off of Research Studies / Clinical Trials requiring site approval on the 6 January 2023.
This SOP applies in a range of circumstances - see third parties and contracts if uncertain.
The research study / clinical trial cannot commence until all relevant permissions are in place, and all contracts have been fully executed.
SOP, V8, 6.1.23
SOP Appendix 1 (Request for Signature Form), 6.1.23
Beaumont Hospital Research Approval Pathway, 8.1.21
Requests for legal review of research related contarcts will only be accepted via the legal services portal which is available to Beaumont Hospital / RCSI staff members who have access to Beaumont Hospital
Intranet. Please note that this link will not open unless you are on the Beaumont Hospital internal network. If you do not have the necessary access, please contact the Beaumont Hospital Principal Investigator to engage with the system on your behalf.
Cover for Research Studies and Clinical Trials under the Clinical Indemnity Scheme
It is a requirement for confirmation of cover under the CIS that the Principal Investigator of a research study / clinical trial taking place in Beaumont Hospital be an authorised healthcare professional employed by Beaumont Hospital. For clinical trials in conjunction with academic institutions, see also GIS State Indemnity Guidance 10 and Clinical Trial Indemnity Form (link to State Claims Agency website)
Studies / Trials involving exposure to Medical Ionising Radiation
Where a study / trial involves exposure to medical ionising radiation, and that exposure is proposed to take place in Beaumont Hospital, it is a requirement to notify the Beaumont Hospital Radiation Safety Committee / Radiation Safety Adviser.