We are delighted to present the first phase of Clinical and Translational Research Repository of Tools and Information.

The overarching aim of this repository is to give clinical researchers from academia, small and medium-sized enterprises (SMEs) and pharmaceutical company representatives a resource, tools and advice on clinical research in Ireland through the ICRIN/MMI website and portal.

In the first phase of this project, directly supported by the HRB and EI , we present the following content:

1. General Information on Clinical Research in Ireland
2. Clinical Research Tools and Guidance for Clinical Trials
3. Flow Diagrams with links to the Clinical Trial Process
4. Frequently Asked Questions
5.Glossary of Clinical Research Terms
6. Translational Research Resources

1. General Information on Clinical Research in Ireland

This section contains information on Competent Authority and Ethical requirements for clinical research in Ireland, as well as information on Research Governance and Sponsorship. It also includes general information on Medical Devices, other interventional therapeutic trials not using Medicinal products or devices, and Diagnostic and Epidemiological studies.

Seminar on a Research Ethics System for the 21st Century, June 2011

Proceedings of the Workshop on Hospital Approval of Clinical Trials, 26 January 2012

Seminar on Research Governance and Sponsorship

2.  Clinical Research Tools and Guidelines for Clinical Trials using an Investigational Medicinal Product (IMP) under the Clinical Trials Directive 2001/20/EC

This section contains 12 Templates, Forms and Standard Operating Procedures (SOPs) for Clinical Research and a list of a further 25 for development.

3.  Flow Diagrams with pertinent links embedded of the Clinical Trial Process for a Study under the Clinical Trial Directive 2001/20/EU using an Investigational Medicinal Product (IMP)

This section includes both flow diagrams with embedded links for Clinical Trial processes and also information on Project Management processes.

4.  Frequently Asked Questions

Below is a series of links to Questions & Answers / FAQ sections relating to clinical trials in general or to specfic clinical trial guidance documents.

 

European Commission Guidance Documents Applying to Clinical Trials- Questions and Answers

 

Medical and Healthcare Products Regulatory Agency (MHRA)- Clinical Trials for Medicines: FAQs

 

National Institutes of Health (NIH) Clinical Center: FAQ About Clinical Studies

 

(NIH) clinicaltrials.gov-  Understanding Clinical Trials: FAQ

5. Glossary of Clinical Research Terms

 

6. Translational Research Resources:

 

The Technology Platform Web-Portal has been developed to provide a central location to promote and showcase the breadth of Irish Technology Platforms and associated expertise and how to access them.

A Bioresource Web-library has been developed to share standardised procedures for the collection, processing and storage of biospecimens with all those who have an interest in biobanking.

 

Further developments on the Templates, Procedures, Forms and Guidelines for Clinical Trials/Investigations will be prioritised by your feedback:  

1.   Prioritisation and Completion by the Quality Management Sub-team of the Templates, Procedures and Forms for the development of IMPs indicated as “coming soon” on the website.

 2.  Definition and Prioritisation by the Quality Management Sub-team  of the Templates, Procedures and Forms for the Development of Medical Devices.

3.   Definition and Prioritisation by the Quality Management Sub-team of the Templates, Procedures and Forms for the Development of Diagnostics.

4.   Elucidation of Flow Diagrams with embedded resources specific to Medical Device development.

5.  Elucidation of Flow Diagrams with embedded resources specific to Diagnostic development.

6.  Development of a Directory of Clinical Research Centres/Facilities from information received from the CRC/Fs.

7.  Development of a Directory of Service providers collated from information received from Clinical Development Service Providers.

8.   Links to Research and Disease Network websites.

9.  Translational Research Tools and Guidelines including a Biomarker Network Web Portal.

10. Training – links to GCP and other relevant courses.