The investigators have the necessary skills, training and experience to undertake their role, and where necessary, appropriate training and supervision have been arranged;
There are suitable and adequate facilities and resources for the project to be conducted at the site as proposed, and they are available for the duration of the project; these include:
Physical resources
Does the organisation have the appropriate facilities, infrastructure available to support the conduct of the clinical trial?
where will your clinical trial take place?
where will patients be treated?
Do you need storage space for supplies?
Is office space for trial staff required?
Staffing
Are staff required to undertake the clinical trial?
Supporting Departments
Are supporting departments aware of the trial and supportive of its conduct?
Is an Access Request Review required?
External providers
Do you need to utilise external providers to supply necessary facilities, resources, staff or infrastructure to support the conduct of your clinical trial?
Financial considerations
Is the budget adequate to undertake the research?
The project has been costed appropriately and there are sufficient funds to cover the costs of conducting research at the site;
Individual service agreements may be required with supporting departments and/or external providers outlining the services to be provided and any costs or fees to be applied for providing the services.
Individual service agreements may be required with supporting departments and/or external providers outlining the services to be provided and any costs or fees to be applied for providing the services.
The project has been costed appropriately and there are sufficient funds to cover the costs of conducting research at the site;
Any legislative requirements, including notification, registration and licence application requirements have been addressed;
Adequate indemnity and insurance arrangements are in place for clinical trials.
Research documents to be used at the site comply with requirements of the Public Health Organisation (e.g. use of site logo, format, provision of site contact details, specific wording to be used in participant information sheet – such as information relating to pregnancy for documents to be used at Catholic hospitals, signatures required on consent forms).
There is ethical and scientific approval for the project and research documents.
