5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
INFANT - Irish Centre for Fetal and Neonatal Translational Research |
|
| Evidence of collaboration with regulatory authorities | Yes | All protocols are generated according to the SPIRIT guidelines and are fully compliant with ICH-GCP requirements. All clinical investigation plans are generated according to ISO 14155 requirements. The regulatory requirements are derived from the EU directives and these are fully recognised and adhered to. The end of trial reports (CTR) are generated according to the CONSORT guidelines. |
| Capacity to provide competent consultation to regulatory authorities | Yes | Prof Geraldine Boylan is a member of the HPRA Clinical trials sub-committee. |
| Formal meetings for clinical trials | Yes | There are generally two investigator meetings per year per research project. Training is performed at these meetings and documented accordingly. Project specific training is as a rule undertaken and delivered by the project monitor at every monitoring visit and is documented in personnel specific training records. For the duration of each project there is also Trial Management Team meetings scheduled for ongoing planning and discussion of the specific projects. |
| Training courses given over the last 2 years | Yes | 10 plus. All research personnel have the opportunity to participate in a regular seminar series, neonatal study days and training workshops. External relevant training programs and courses are also available to all personnel and opportunities to present at international conferences are open to all personnel. Regular GCP training and refresher courses are given by trained personnel to all research personnel. Prof Geraldine Boylan in conjunction with Neonatal Brain Research Group (NBRG) are hosting 9th International Conference in Brain Monitoring and Neuroprotection in Cork Ireland in 2015. 6 week course on Medical Ethics incorporating the following modules: Introduction to Research Ethics Respect for Subjects: Consent and Confidentiality Different Clinical Forms of Consent The Risk- Benefit Relationship in Clinical Research Ethics of Randomised Controlled Trials Ethics & Research involving Children and other Vulnerable Groups Neonatal Patients Elderly & Mental Health Patients Developing the Patient Information Leaflet & Drafting a Consent Form for Clinical Research: Issues to Consider Ethics & Data Protection in Healthcare Research Ethical Roles and Responsibilities from different research perspectives i.e. investigator, sponsors, participants This course is open to Masters and PhD students. |
| Training courses received over the last 2 years | Yes | 10 plus, It is mandatory for all research personnel to have up to date GCP certification therefore attendance at GCP and ISO 14155 courses is encouraged and required. Personnel also attend regular seminar series, international conferences and investigator training. Monitoring/Auditing courses are also completed on a regular basis. |
| Promotion of participation in clinical trials in countries with limited resources | No | |
| List of Countries |