Patient Focused Research
UCC approval process for Patient Focused Research
All research involving patients/volunteers must be approved by UCC Sponsor's Office before they start. This includes Clinical Trials of Medicinal Products, Clinical Investigations of Medical Devices, studies of other interventions (such as nutrition, exercise, care pathways) and observational studies. UCC Sponsor's Office will log the study and add it to the list of studies on the UCC clinical trials insurance log.
The flowcharts presented here outline the processes to be followed:
(A) Post funding/award approval process
(B) Post greenlight approval process
The Clinical Research Sponsorship Request Form (SRF) should be completed by the Investigator when applying for funding for a clinical research study. The purpose of the SRF is to request that UCC provides sponsorship for the proposed clinical study. This includes planning appropriate insurance cover for study subjects, University personnel involved in conducting clinical study and the University itself. Please send to UCC Research when completed:Sponsorship request form
When awarded funding for a clinical research study, the Investigator should complete a Patient-Focused Research Questionnaire (PFQ) and send it to UCC Sponsor’s office for review, categorisation and logging for UCC insurance cover.
The Study Protocol and Patient information leaflet/Informed consent form (final or draft version) should also be included if available. The point of contact for completed PFQ is PFRSponsor@ucc.ie
Patient Focused Quality Working Group
Patient focused research is carried out over a broad range of departments, research centres and units at UCC. Clinical trials of investigational medicinal products (CTIMP) and clinical investigations of medical devices are governed by Irish and European laws, directives and guidelines; therefore, clear guidelines exist regarding the quality standards which must be complied with for this type of research.
However, there are no defined quality standards for the conduct of non-regulated patient focused research, including observational research and non-CTIMP interventional trials. Such interventions may include food products, nutritional supplements, physical and psychological interventions. The majority of the patient focused research carried out in UCC is of this non-regulated type.
A Patient Focused Quality Working Group (PFQWG) consisting of representatives of many of the departments, research centres and institutes which carry out patient focused research in UCC, including APC Microbiome and Infant, has been set up within UCC. It is chaired by Ruben Keane, the Quality and Regulatory Affairs Director of the HRB Clinical Research Facility Cork
One of the aims of this group is to develop and share ‘generic’ Standard Operating Procedures and templates which researchers can use and adapt for their own patient focused research.
These SOPs and templates can be found here and more will be added by the PFQWG over the coming months.
Dr Ruben Keane - Quality and Regulatory Affairs Director (021-4901928) - email@example.com
Health Research Regulations 2018
Please view Health Research Regulations 2018 forms in Frequently Used Forms.