Is there a storage area on site for test articles?

Yes.

Most test articles can be stored at the study site. If required, Beacon Hospital (adjacent to the site) can be approached to assist with storage if study specific requirements cannot be met on site. There are multiple refrigerators on site but no -20˚C or -80˚C freezers. USB temperature monitors are used to ensure storage temperature and humidity requirements are met.

Can storage condition requirements be monitored for study supplies?

Yes.

Storage conditions are continuously measured using USB monitors. Temperature, humidity and dew point are measured. Graph can be exported for audit trail.

Does the site have a dedicated study co-ordinator?

Yes.

There are two full time study coordinators on site.

What staff members are involved in studies?

All staff members are involved in our research projects, with varied degrees of involvement based on their role in the clinic. Our team consists of Practice Manager, Clinical Nurse Manager, 4 Ophthalmologists (3 of which are surgeons) 3 Optometrists, 2 Ophthalmic Nurses, 2 Ophthalmic Technicians and 2 Study Coordinators. All clinical staff have current GCP certificates

Has the site conducted clinical trials or studies previously?

Yes. To read more about the studies the clinical trials/studies conducted at the site visit "Facility" page.

Does the site have experience with submitting data to reading centres?

Yes.

Yes, the site has used multiple reading centres for previous studies for various test types.

Does the site have experience with electronic Case Report Forms (eCRFs)?

Yes.

The site has used multiple eCRFs for previous studies including Marvin, Excelsior and Medidata RAVE.

What areas of research is the site interested in?

The site is passionate about research and eager to participate in multiple research areas however site facilities and current patient population mean that the site is best suited to the following types of studies; medical devices, cataract, glaucoma, refractive and general ophthalmology. As the site does not have the facility to obtain blood samples or administer IV drug infusions, this limits the amount of drug trials we can participate in. The site participates in some large multi-centre drug trials that have known ophthalmic side effects and support the main site by performing the required ophthalmological exams.

Is the local EC a central EC for Ireland?

No.

Beacon Research Ethics Committee is not a central EC. Therefore, applications may be required by more than one EC in Ireland if there is more than one Irish site.

How often does this ethics committee meet?

Every 3 months.

What is the expected turnaround time for EC approval?

The EC will issue their opinion letter approximately two weeks post meeting date. If an amendment is required, it may not be necessary to wait until the next scheduled meeting date for review. The committee may be able to review via email and in that case, approval can be expected approximately 2 weeks post amendment submission. This may vary depending on the nature of the amendment and Sponsor may be guided by the site.

How does the application process work?

The EC application form must be completed and accompanied by a number of other documents such as the Protocol, Patient Information Leaflet and Informed Consent Form. Sponsors are also required to submit Insurance Certificates, Clinical Trial Agreements and budget details.

For all proposed applications, the Clinical Research team will review the application documents before submission. If required, support can be offered from the Clinical Research team in the document drafting stage. The Sponsor would reimburse the clinic for time spent drafting documents on their behalf and this can be arranged through the Practice Manager if required for your project.