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) Pre-funding/award approval process

(B) Post funding/award approval process

(C) Post greenlight approval process

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.

Patient focused research questionnaire (PFQ)

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 Marie Costelloe-Barry m.costelloe@ucc.ie.

Dr Muiris Dowling - Clinical Research Reporting Officer (021-4901902) - maurice.dowling@ucc.ie

Ms. Marie Costelloe-Barry - Clinical Research Admin Support (021-4901930) - m.costelloe@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) - ruben.keane@ucc.ie

Health Research Regulations 2018

Please view Health Research Regulations 2018 forms in Frequently Used Forms.