What is a clinical investigation? One important change with respect to the MDR is that there are a number of different types of clinical investigations specifically described within the legislation, including: Pre-market clinical investigations, i.
Post-market clinical investigations, i. Clinical Investigations undertaken for purposes other than those listed in Article 62 of the MDR see Article 82 of the MDR and the additional requirements laid out in national legislation S.
What type of supports does the HPRA provide to device developers? This is a cross departmental initiative in the HPRA to support any innovative medical product. Further information is available on the Innovation Office webpage. Preliminary meetings with device developers. The purpose of these meetings is to provide an introduction to the role of the HPRA and a broad overview of the regulatory requirements in the pre-market phase of medical device development.
Pre-submission meetings. These are typically for study sponsors who have prepared for a clinical investigation in Ireland, and who may have some outstanding questions prior to the submission of their application to the HPRA.
Step 2 : Pay the relevant fees. Please be advised that expressions of interest are required to be received and agreed in advance of applications being submitted for consideration under the National Collaboration Project. For further information, please contact clinicaltrials hpra.
A list of cut-off dates for submission of CT Applications are available below. Clinical Trial Meeting Dates for and Subcommittee dates Clinical Trials Seminar Medicines Regulatory Information Clinical Trials. Clinical Trials Before a medicinal product can be authorised for use, it must go through the clinical trials process to ensure that it is safe and effective and also that the quality of the product is sufficient.
Our Role The HPRA, in tandem with the various ethics committees, is responsible for the assessment and approval of clinical trial applications in Ireland. I am looking for progesterone.
I am looking for hormone therapy. I am looking for HIV Vaccine. I am looking for bicalutamide. I am looking for pembrolizumab. Advanced Filters. Found clinical trials By relevance By distance By last updated By most viewed. Featured trial. It is unique to every trial and is generated based on a trials specific data eg. CuidaTXT: a Text Message Dementia-caregiver Intervention for Latinos Latino families with dementia experience substantial disparities in access to caregiver support compared to their non-Latino white peers, putting them at an increased risk for negative emotional, physical and financial outcomes.
This R21 will address this research gap by 1 Developing a culturally and linguistically appropriate text message intervention for … cognitive impairment.
Accepts healthy volunteers. Online studies. University of Kansas Medical Center. The online family caregiver training program: Supporting African American caregivers In this research study, you will be asked to help construct content and evaluate an online training module for caregivers. Participants will be asked to provide feedback on content and barriers for online delivery and usage, as well as engage in discussion of any suggestions to make the online tool … Accepts healthy volunteers.
Wayne State University. Development of an Intervention for Long-Distance Caregivers We are seeking long-distance caregivers of persons with dementia to participate in an advisory board to assist in the development of an intervention for long-distance caregivers, which will be tested in an upcoming study. Exergame Study for Family Caregivers Caregivers, we are inviting you to join a fitness study to find the best ways to help caregivers increase physical activity.
Brandeis University. We … Accepts healthy volunteers. University of Nebraska at Omaha.
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