Module Catalogue 2024/25

Pre Requisite Comment

N/A

Co Requisite Comment

N/A

Aims

To familiarise the students with the core aspects of Clinical Research Delivery and the surrounding ecosystem. This includes the importance and diversity of clinical research in health and social care, as well as the culture and landscape of clinical research. The module is designed to allow students to put into context, implement and critically evaluate some of the core skills they have developed in other aspects of their course.

Outline Of Syllabus

●       The importance, value, and diversity of research in healthcare
●       The importance and value of networked research
●       The culture and landscape of research
●       Research and Development departments (or their equivalent): how do they operate? How do they fit into
the hospital structure?
●       Research Networks (e.g. NIHR CRNs, research networks of major charities, professional body research
networks etc.): what can the network support? How do you navigate the system to secure the support you
need?
●       Public and patient engagement and involvement in research – how this influences the design of studies
and prioritises research questions that need to be answered

Intended Knowledge Outcomes

Upon completion of this module students will be able to:

•       Appraise the impact of clinical research on healthcare delivery
•       Discuss the different stakeholders in clinical research and argue how they all fit into the clinical
research ecosystem, including the importance of network research in this ecosystem
•       Evaluate the journey pathway of a clinical study from managing a sponsor’s expression of interest
process to closing a study
•       Argue the importance of the Public and Patient Engagement and Involvement (PPEI) in research – how this
influences the design and conduct of studies and prioritises research questions that need to be answered

Intended Skill Outcomes

Upon completion of this module students will be able to show how they have been able to reflect on their role and how it relates to a number of different task related to clinical and healthcare research including:

•       Reporting and communicating to different groups
•       Recruiting and screening of participants for studies
•       Managing the informed consent process, including receiving consent in studies that include
participants that lack capacity and managing consent for online studies
•       Leading patients through pathways
•       Taking participants through studies
•       Managing data including recording and checking for accuracy
•       Auditing project files
•       Safety reporting (initial and follow up)
•       Closing a study, and the Principal Investigator’s role within that part of the process

Teaching Rationale And Relationship

The Module will be delivered as a combination of study in the workplace together with support via our VLE through a series of guided learning opportunities including delivery of e-based content, asynchronous activities, discussion boards, and workshops.

The students will be assigned a workplace supervisor (via Clinical Research Networks ) to supervise through the module and monitor progress on the skills portfolio. This process will be managed by the Workforce Development Lead for the Clinical Research Network North East North Cumbria (CRN NENC), who will co-ordinate with other regional CRNs to ensure appropriate matching of student and supervisors. The supervisor will be an experienced clinical researcher who is working on a research study within an NIHR local CRN. They will work with the learner to identify both their learning needs and the ways in which the learner’s Trust can facilitate their learning. They will support the learner throughout the module and complete an end of RPE report which will feed into the Reflective portfolio assignment. Student will meet their supervisors at the start of the module and monthly for review meetings, where they will be required to reflect on and receive feedback on their skills portfolio. Meetings will be virtual or person in place as appropriate due to geographic locations, schedules, and any ongoing health situations.

Assessment Rationale And Relationship

Lay and professional project summary: (40%)
Rationale: communication to different groups including feeding back to patients and public as well as organisation/ profession and arguing the impact of clinical research. Authentic task-based assessment mapping to learning outcome: Reporting and communicating to different groups.
     
Students that are required to resit this component will resubmit the assessment using the same assessment task of lay and professional project summary.

Reflective Portfolio (60%)
Rationale: This will ensure that the students can reflect on the core skills aligned with the module and their importance for clinical research. Mapping to remaining learning outcomes.

Students that are required to resit this component will be given the opportunity to resubmit the assessment within a given period of time agreed with the DPD and module lead.

The formative Mid Module Portfolio will be used to reflect on progress on the module and the capabilities accomplished.

In order to pass this module, students are required to achieve an overall pass mark of 50 or above for both assessments in the module as well as the module overall.

General Notes

Only students with a nominated workplace supervisor will be allowed to take this module