NIHR Podcast Series Spring/Summer 2020 – Study Design in Clinical Research

The course is designed around the RCN Research Nurse Competency Framework with focus on each competency as a separate module It builds on the Fundamentals of Clinical Research course which candidates should have attended prior to applying for this course.

To ensure lab staff working on COVID clinical research are trained to understand the necessary requirements for laboratories.

This module is aimed at staff involved in the delivery of clinical trials of Investigational Medicinal Products (IMPs) that are working under the guidance of written SOP, for example, study specific instruction, pharmacy / IMP manual, or study protocol. This module is a mix of self led E-Learning and face to face conversation with your Trust IMP management specialist (for example, clinical trials pharmacist / pharmacy technician).

Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted ensuring the rights, safety and wellbeing of research participants are protected and that research data are reliable. The NIHR CRN ensures compliance with GCP by providing high quality online learning programmes. This classroom/virtual consolidation workshop is designed to follow the online learning and build on knowledge gained by working through activities discussing local issues and learning from other colleagues.

This workshop is designed to reinforce and consolidate knowledge already acquired. It is aimed at experienced research delivery staff who have previously completed our Introduction to Good Clinical Practice (GCP) training and have recent practical experience of working in a clinical research environment.

This training is appropriate for some staff working on clinical trials involving genetically modified (GM) vaccines. It is one of several learning resources in the Covid 19 Vaccine Trial Training Matrix compiled by the Clinical Research Network to ensure the workforce are suitably trained to support Vaccine Trials. Learners may be asked to complete this course by their NHS Trust R&D department or by a specific research study sponsor in preparation of their role in delivering or supporting delivering of the vaccine trials.

Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted. Compliance with GCP provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable.

To ensure clinical staff caring for COVID patients in isolation wards are able to seek informed consent for non-randomised, observational studies – initially this being in support of the ISARIC study

Informed consent in a paediatric setting e-learning. This course is designed to provide an introduction to the process of informed consent in a paediatric setting. It explores who can give consent for a child to participate in research and the process of assent, through which the views and agreement of the child are sought. The requirements for ctimp and non-ctimp research are covered including those included in the medicines for human use (clinical trials) regulations.

Informed consent with adults lacking capacity. This course is designed to provide an introduction to informed consent with adults lacking capacity. It explores the requirements of the mental capacity act and medicines for human use (clinical trials) regulations when involving adults who lack capacity in non-ctimp and ctimp research.

This full-day workshop is designed to provide an introduction to good clinical practice (gcp), the EU directives, UK regulations and research governance framework requirements covering clinical trials and other nihr portfolio studies conducted within secondary care (primarily hospital based) settings.

Introduction to good clinical practice (gcp) e-learning. This course is designed to provide an introduction to good clinical practice (gcp), the EU directives, UK regulations and research governance framework requirements covering clinical trials and other nihr portfolio studies conducted within the NHS. Primary care and secondary care pathways are included as well as options to explore the consent process requirements in a paediatric setting and with adults lacking capacity.

Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted. Compliance with GCP provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable.

This e-learning course is designed to provide an introduction to GCP for research delivery staff involved in the management of Investigational Medicinal Products (IMPs) at research sites.

This course is designed to provide an interactive introduction to the principles of valid informed consent for those staff working with clinical research participants.

A series of four podcast interviews with different subject matter experts on the central theme of ethics. The series includes a discussion forum and a quiz. Learners can complete at their own pace in any order. After completing each quiz learners will receive a certificate and CPD credits (TBC). Course can be found on NIHR Learn and Open Learn

A series of four podcast interviews with different subject matter experts on the central theme of patient public involvement. The series includes a discussion forum and a quiz. Learners can complete at their own pace in any order. After completing each quiz learners will receive a certificate and CPD credits (TBC). Course can be found on NIHR Learn and Open Learn

A series of four podcast interviews with different subject matter experts on the central theme of special patient groups. The series includes a discussion forum and a quiz. Learners can complete at their own pace in any order. After completing each quiz learners will receive a certificate and CPD credits (TBC). Course can be found on NIHR Learn and Open Learn

This master class aims to provide practical solutions to empower PIs to enhance effective oversight of their studies. It applies an evidence-based adult learning approach, which enables PIs to utilise their existing knowledge, learn from others and consider how they can apply what they are learning directly to their practice.

To ensure all staff working on COVID clinical research are trained in the fundamentals of GCP. This will be a foundation for role specific training for staff groups provided by the study management team