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• Description

Research Practice Experience

Module description

This is a fully online module.

During this module you will draw upon the theoretical learning from modules 1 and 2 through engaging in an active clinical research project. Paired with an experienced clinical research supervisor, you will shadow to develop expertise, before taking on specific delegated tasks as part of the project team. You will meet regularly with your supervisor to determine your ongoing learning, plan the tasks needed to demonstrate your capabilities and prepare to take on increasing responsibilities. As you progress, you will reflect on your learning both in discussion with your supervisor and through written reflection, which you will apply in practice.

Module aims - intentions of the module

This module aims to develop your capability and confidence as an experienced clinician, with the ultimate aim of supporting you to discharge the duties of a co- or sub-investigator in a clinical research study. Your duties will be protocol specific and contextual to the clinical research in your health / care setting. It is not anticipated that you will have necessarily had experience of all these duties by the end of the RPE module, but it is expected that you will have developed capability towards meeting the module outcomes. It is anticipated that you will spend time working in a clinical research environment developing your leadership skills alongside formal module learning to underpin and support clinical leadership practice.

Intended Learning Outcomes (ILOs)

ILO: Module-specific skills

On successfully completing the module you will be able to...

• 1. Comprehensively and systematically understand the clinical research ecosystem, including the importance, value and diversity of clinical research in health / care, the importance and value of networked clinical research and the culture and landscape of research.
• 2. Demonstrate an applied understanding of the data collection process within the framework of networked clinical research studies.

ILO: Discipline-specific skills

On successfully completing the module you will be able to...

• 3. Comprehensively understand research and development in terms of how it is organised into institutional and departmental structures and cross-institutional networks, including the roles and responsibilities of key personnel within each.
• 4. Understand the need for public and patient engagement and involvement (PPIE) in research – how this influences the design and conduct of studies and prioritises research questions that need to be answered.

ILO: Personal and key skills

On successfully completing the module you will be able to...

• 5. Critically evaluate your research practice experience and identify the knowledge and transferrable practices that you will take forward to subsequent research projects.
• 6. Reflect critically on the nature of the contributions made by specific individuals and organisations to the research project in which you are involved.

Syllabus plan

Whilst the module’s precise content may vary from year to year, an example of an overall structure is as follows:

The RPE is structured around two high level learning outcomes, which are presented below as Capabilities in Practice (CiPs) that you will be expected to demonstrate on completion. CiPs are based on the format of Entrustable Professional Activities (EPAs).
(Module core content)
CiP1: To develop an in-depth understanding of the clinical research ecosystem
a. The importance, value, and diversity of clinical research in healthcare.
b. The importance and value of networked clinical research.
c. The culture and landscape of research.
d. How does clinical research work?
e. Who are the key personages in research (to include the roles and responsibilities of a sponsor, Chief, Principal and Sub- or Co- Investigator; Back up Physician; Blinded / Masked Physician or Assessor; the role of HRA / MHRA in approving studies, other regulatory agencies)?
f. Key teams who may be external to the core research team but are critical to the delivery of clinical research.
g. Research and Development departments (or their equivalent): how do they operate? How do they fit into the hospital structure?
h. Research Networks (e.g. CRNs, research networks of major charities, professional body research networks or equivalent research networks): what can the network support? How do you navigate the system to secure the support you need?
i. Public and patient engagement and involvement (PPIE) in research – how this influences the design and conduct of studies and prioritises research questions that need to be answered.
j. Study feasibility

CiP2: To manage the steps involved in data collection within a networked clinical research study
You are unlikely to complete all tasks in CiP2; your ability to complete specific tasks will be context and study dependent. What matters is that your supervisor can confidently entrust you to manage the steps involved in data collection within a networked clinical research study (under the supervision of a PI).
a. Checking it is appropriate for you to contribute to clinical research study.
b. Site initiation and selection
c. Recruitment strategy
d. Sampling (people, activities, records, time periods, etc) for this networked clinical research study
e. Screening participants for studies.
f. Recruiting participants.
g. Informed consent process, including receiving consent in studies that include participants that lack capacity and managing consent for online studies.
h. Taking patients through pathways.
i. Taking participants through the various study milestones.
j. Trial Treatments, where applicable (to include preventative treatments, surgery, radiotherapy, and other interventions).
k. Recording data and checking for accuracy.
l. Research Specific Audits and monitoring.
m. Safety reporting (initial and follow up).
n. Closing a study, and the Principal Investigator’s role within that part of the process.

Learning activities and teaching methods (given in hours of study time)

Details of learning activities and teaching methods

Formative assessment

Summative assessment (% of credit)

Details of summative assessment

Details of re-assessment (where required by referral or deferral)

Re-assessment notes

As the portfolio is generated over 50 h of clinical experiences and the 2000-word reflection relates directly to the portfolio, the re-assessment timings will need to be determined by agreement between the student, supervisor, academic tutor and module lead(s). It should be possible to resubmit 12 weeks after the initial result in most cases.

Indicative learning resources - Basic reading

• Aarons, G. A., M. G. Ehrhart, L. R. Farahnak and M. Sklar (2014). "Aligning leadership across systems and organizations to develop a strategic climate for evidence-based practice implementation." Annu Rev Public Health 35: 255-274.
• Barr, J. & Dowding, L. (2016) Leadership in health care. 3rd edition. London: Sage
• Chaudoir, S. R., L. G. Dugan and C. H. I. Barr (2013). "Systematic review factors affecting implementation of health innovations: a systematic review of structural, organizational, provider, patient, and innovation level measures." Implement Sci 8(22).
• Christensen, C.M, Bohmer, R. & Kenagy, J. (2000) Will disruptive innovations cure health care? Harvard Business Review Sept 103-111
• Dale, B., Van der Wiele,T., & Van Iwaarden, J. (2007) Managing Quality 5th ed FT/Prentice Hall
• Francis, R (2013) Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry Executive summary London: The Stationery Office 
• Gopee, N. & Galloway, J. (2014) Leadership & management in healthcare. 2nd edition. London: Sage
• Jacobs, S. R., B. J. Weiner and A. C. Bunger (2014). "Context matters: measuring implementation climate among individuals and groups." Implement Sci 9: 46.
• Kotter, J.P (1995) Leading change: Why transformation efforts fail. Harvard Business Review March 59-67
• Kotter, J.P (1999) What Leaders Really Do. Boston, MA: Harvard Business Review Books
• Monitor (2013) Closing the NHS funding gap: how to get better value health care for patients https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/284044/ClosingTheGap091013.pdf
• Hawe, P. 2015. Lessons from complex interventions to improve health. Annu Rev Public Health, 36, 307-23.
• Hooper, A. & Potter, J. (2000) Intelligent Leadership. London: Random House Business Books
• Slack, N., Brandon-Jones, A., and Johnston R. (2011) Essentials of Operations Management, FT Prentice Hall.

Indicative learning resources - Web based and electronic resources

• ELE:

-          Module ELE Page (https://vle.exeter.ac.uk/course/view.php?id=13713)

-          CMH Postgraduate Programmes FAQs page (https://vle.exeter.ac.uk/course/view.php?id=7584)

-          Master’s Level Learning Induction Course (https://vle.exeter.ac.uk/course/view.php?id=7584§ion=1)

• Library:

-          Medicine LibGuides (https://libguides.exeter.ac.uk/MedicineHomePage)

• NIHR Learn– sign up with your Exeter email (https://www.nihr.ac.uk/health-and-care-professionals/learning-and-support/)
• Introduction to Research: https://learn.nihr.ac.uk/course/view.php?id=459
• Next Steps in Research: https://learn.nihr.ac.uk/enrol/index.php?id=682
• Getting into Research – Primary Care: https://learn.nihr.ac.uk/enrol/index.php?id=938
• Research Delivery e-learning Modules: https://learn.nihr.ac.uk/mod/page/view.php?id=9555
• Health Education England e-learning - Sign up with your Exeter email: https://populationwellbeingportal.e-lfh.org.uk/login

Indicative learning resources - Other resources

• Recorded lectures

Key words search

Clinical research delivery, research ecosystem, reflective practice, practical experience, critical reflection, synchronous learning, online learning