Fundamentals of Clinical Research This course is designed for nurses and AHPs who are new to research posts, (in post for more than 6 months and as a refresher for all research staff. The NIHR GCP course is a prerequisite for this course. Objective The objective is to provide a foundation of knowledge to enable you to develop your practice as a clinical research employee. It offers the opportunity to gain an understanding of the management and running of clinical studies. You will be able to apply relevant knowledge and skills gained from the course to your working environment, and you will be able to build on your experience as a nurse and or AHP in the NHS environment. Course Elements Eleven course elements will be covered during the 2- day course in 30-60 minute slots. There will also be course introduction and evaluation sessions. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Historical context of research The basics of clinical research methodology Human subjects protection, advocacy and the 6 C’s Patient information giving and Informed consent: process and principals Recruitment and retention of patients in clinical research Protocol review and feasibility Study management and documentation Roles and responsibilities of the research team Monitoring, audits and MHRA Drug and medical device development The national and international picture Delivery The course will be delivered using a variety of teaching strategies include lectures, groupwork and student-led discussions. Assessment Course assessment will include a multiple choice questionnaire and completion of a 3 month post course reflective piece for submission into your professional portfolio as evidence of learning. Fundamentals of Clinical Research Application Form Contact Information Name Current job role Click here to enter text. Click here to enter text. Click here to enter text. Work address Work postcode Work phone number E-mail address Click here to enter text. Click here to enter text. Click here to enter text. Your network Click here to enter text. Which date are you applying for: ☐ DAY 1 – 15 June 2016 Room 2-3 BRC 16th Floor Guys Tower SE1 9RT ☐ DAY 2 – 22 June 2016 Room 2-3 BRC 16th Floor Guys Tower SE1 9RT NB: Attendees need to attend both days to get a certificate. Personal Reflection Please write a brief reflection (no more than half of one side of A4) on what you believe you will have to offer to your research role, as a result of undertaking the CRN Course. You may find the following questions helpful in writing this reflective piece. We ask you to draw on your own experiences when answering these questions. How long have you been involved in clinical research? This course requires you to have completed GCP training, how do you keep up-to-date with the regulations? Can you outline a recent change you have made in your research role? How did you implement this change and what effect did it have on the research capacity of your team? How do you work as an individual/team to ensure your daily practice is of the highest standard? What, in your opinion, is the biggest skill/knowledge gap in Clinical Research that needs to be addressed through training? How can you demonstrate a willingness to help create a high quality learning environment? How do you intend to share your knowledge and to whom? Are you willing to collaborate across your network? Complete your personal reflection here: Click here to enter text. Knowledge of the CRN Course Will you ensure you have the protected time to prepare and participate in this 2 day course, and to share the learning afterwards? Click here to enter text. Support for your application Your line manager name Line manager address Line manager phone number Click here to enter text. Click here to enter text. Click here to enter text. Please ask your line manager to write a statement of support for your application demonstrating that they understand the time and cost implications (travel and one night accommodation) of you undertaking the course and that they are supportive of this. This statement can be entered in the space below or sent as a separate document/email if they wish. Click here to enter text. Closing date and application details: The closing date (Usually 2 weeks before the actual course date unless specified) Applications to: Ola Famurewa at Olawale.Famurewa@gstt.nhs.uk Applications will be considered on a first come first served basis and a waiting list system will be operated if there are a high number of applications. The course convener is Nhlanhla Mguni Workforce Lead and ARDM for Division 6.