FACULTY OF NURSING AND MIDWIFERY ROYAL COLLEGE OF SURGEONS IN IRELAND

Education Modules - Clinical Research

The Royal College of Surgeons in Ireland, working with the Dublin Centre for Clinical Research (DCCR) and Molecular Medicine Ireland, and supported by the Health Research Board (HRB) and the Wellcome Trust, are pleased to have initiated the first formal programme of education for Clinical Research Nurses in Ireland. The Certificate in Nursing (Clinical Research) course started in the Faculty of Nursing, RCSI, in September 2009. This course consists of three modules:

• Research Design & Methodology
• Clinical Research Practice & Management
• Ethics and Regulatory Affairs

In order to be awarded a Certificate in Nursing (Clinical Research) participants must also demonstrate competence in the clinical area through completion of a competency schedule and compilation of a portfolio.
Two of the modules are generic and are appropriate to all research staff, therefore we are inviting applications to complete one or two of the programme modules as stand- alone modules. Successful completion of an individual module (assessed by assignment) will lead to the award of 10 credits at level 9.

The title, content and study days include:

Clinical Research Practice and Management
This module covers all aspects of study management, including study set-up, budgeting, essential documents, patient recruitment and visit management, medication management, handling and transport of biological samples, maintenance of site files, discrepancy management, study closeout and archiving. It also includes the role of the clinical research nurse, the role of the CRA (Clinical Research Associate), and of CROs (Clinical Research Organisations).
Dates: 10/11/09; 24/11/09; 08/12/09; 12/01/10; 19/01/10.

Ethics and Regulatory Affairs
In this module we discuss the core ethical principles and ethical issues in research. The module includes lectures on informed consent, organ and tissue retention, third world research, the role of ethics committees and preparing an ethics application. Also included are an introduction to healthcare law, Irish and EU regulations governing research, regulatory inspections and clinical indemnity. This module also incorporates the ICRIN ICH GCP study day, which all clinical research staff are required to attend bi-annually.
Dates: 02/02/10; 09/02/10 (ICH GCP); 16/02/10; 02/03/10; 09/03/10.

Cost: €650.00 per module

Further information:
Deirdre Hyland, Course Coordinator,
Clinical Research Centre,
Smurfit Building, Beaumont Hospital,
Beaumont, Dublin 9.
dhyland@rcsi.ie
Ph: +353 1 8093809
or from www.rcsi.ie/nursing

Applications:
Administration Office,
Faculty of Nursing and Midwifery,
Royal College of Surgeons in Ireland,
123 St Stephens Green,
Dublin 2