Adverse Event & Safety Reporting
This session will enable you to recognise the importance of pharmacovigilance in clinical trials, be able to recognise different types of adverse events, be aware of legal requirements with regard to reporting adverse events, be able to implement local SAE reporting procedures
An Introduction to the Valid Consent Process

The Consent course aims to provide a sound grounding in the standards required when receiving consent in clinical research. It builds on the knowledge and understanding gained through completing the Introduction to GCP course. Participants can expect to gain a fuller understanding of the process of receiving consent and the roles and responsibilities of the research team.

Archiving -Expectations and Reality

This course would be suitable for Research Nurses; Trial Coordinators, Research Administrators,  Principal Investigators and any other healthcare professional involved in research and will give an understanding of the historical context of archiving, the importance of archiving, the  regulatory & legal frameworks and archiving challenges

Building Research Partnerships

NIHR Patient and Public Involvement and Engagement (PPIE) initiatives supported by the Clinical  Research Network West Midlands (CRN WM):                                                         

This training will provide you with information on the current NIHR PPIE initiatives and explore ways that these initiatives can be delivered within your research and within your organisation.                    

Patient and Public Involvement and Engagement (PPIE) in Research Training (for LAY people):

 Building Research Partnerships (BRP) training has been designed to inform and educate research professionals and members of the public and patients about exploring the ways patients and members of the public can and should take part in research development at NHS organisations. This training will provide you with information and ideas about how you can develop involvement and engagement with patients in research at your organisation.

Cost Attribution Training (AcoRD)

This course goes back to basics on cost attribution. An introduction to the DH AcoRD Guidance will be provided and various scenarios will be explored to explain the differences between a research cost, treatment cost and support cost. 

Data management & CRF design, development & completion

This course would be suitable for all researchers and associated staff that will be/are responsible for data management, and the design and collection of data in clinical trials

Effective AAC for Partner Organisations (formerly HRA Masterclass for Participating Organisations)

This session is aimed at R&D staff, and Support Departments (i.e. anyone at the Trust involved in the Assess, Arrange and Confirm process).  The session is a practical discussion based session around real protocols and how these would need to be considered at Trust level.  The key considerations around Research team, Staff, Resources and SOPs/Policies are discussed in light of the different types of studies.

Facilitator Development Training

This course provides an opportunity for experienced research staff (clinical and non clinical) who are interested in delivering training on research topics to develop and enhance their ability to enable others to learn.  It aims to prepare facilitators who are committed to delivering regional training sessions using standard materials and is a re-requisite for all NIHR-endorsed training. 

Feasibility Workshop

This workshop aims to help investigators and research teams to attract commercial and non-commercial research and provide practical techniques to help make studies successful. The session walks through the life-cycle of a study from the site perspective, starting with the initial feasibility assessment.

GCP for IMP Management Consolidation Workshop

A workshop aimed at pharmacy staff that have completed the NIHR GCP for IMP Management Online Course. To enable Understanding of the context of clinical trials in a pharmacy dept, share best practice examples and enable problem solving and risk management in trial set up and delivery 

Good Clinical Practice e-learning :NIHR Learn e-learning

The following on-line training can be accessed through NIHR Learn-

  • Introduction to Good Clinical Practice
  • Good Clinical Practice refresher
  • Informed Consent in Paediatric Research
  • Informed Consent with Adults lacking capacity
  • Introduction to Good Clinical Practice (Primary Care)
  • Introduction to GCP for IMP management (Pharmacy)

PLEASE CLICK ON THE NIHR LEARN TAB, TO GO TO THE NIHR LEARN WEBSITE TO VIEW AND BOOK THIS TRAINING

Good Clinical Practice Refresher

An update on the key changes to the UK Medicinal Products (Clinical Trials) Regulations since their publication in 2004 and a refresher on Good Clinical Practice (GCP) and the Research Governance Framework (RGF). The session is designed to develop participants previous knowledge and experience of translating principles into practice. 

Good Clinical Practice: Introduction to GCP in Primary Care

This course provides an introduction to GCP in a primary care setting. The content covered in the primary care and secondary care versions of this course are the same, though the context in which they are applied is tailored to primary rather than secondary care settings.

Good Clinical Practice: Introduction to Good Clinical Practice

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. Participants can expect to gain a demonstrable understanding of the background and practical implications of GCP. 

Improvement & Innovation Training

The Improvement & Innovation Training Workshops are two half-day sessions- Session1: Improvement Project Planning and Session 2: Project Delivery -aimed at explaining to trainees what continuous improvement is, the Clinical Research Network approach to continuous improvement (Plan, Do, Study, Act) and provide knowledge of tools that would enable you to carry out improvement projects and/or supporting colleagues in carrying out their own projects

Introduction to Clinical Genetics and Research Overview

This session provides an introduction to the basic principles of genetics and inheritance, and their application to medicine.  The session will include an overview of the cancer genetics and general genetics services operating in the West Midlands. Areas of research interest as well as ongoing studies relevant to clinical genetics patients will be discussed

Introduction to Clinical Research

This course is for new clinical research staff (Research Nurses/Facilitators/support staff/ Data  Managers) who have been working in a research role for less than one year. The course provides a basic overview of research roles and the clinical research process which builds on the theory and practical sessions of ICH Good Clinical Practice training. It is intended for site staff from any clinical speciality who are involved in the conduct of clinical research. 

Introduction to Imaging in Clinical Research

This session will inform you of what do Imaging need to know in order to approve a clinical study and why, assist you in understanding various imaging modalities, the legal requirements for exposure to ionising radiation and he implications to ionising radiation

Introduction to Medical Terminology for Research Staff

This course aims to develop an awareness of the range of medical and nursing terminology in everyday use in clinical research settings. By the end of the session learners will be able to identify common abbreviations and interpret them correctly, identify and demonstrate the use of resources to assist the interpretation and use of medical terminology and recognise the adverse consequences related to the incorrect use of terminology / abbreviations.

IRAS and HRA for Sponsors/Research Teams

This training is for researchers, study coordinators, Sponsors and support staff who who maywant an overview on how Research is conducted in the NHS and what the expectations are from NHS organisations in accordance with the HRA approvals process. This course provides a comprehensive overview of the Research Management pathway for studies conducted in the NHS. It begins with a basic introduction into the research landscape, roles and responsibilities, completion of IRAS forms, how to submit your study for consideration on NIHR Portfolio.  

 

Let’s Talk Trials

This course helps explore key communication skills and principles for approaching and discussing participation in clinical research trials with patients. This approach can be utilised for other situations, including the breaking of bad news or having those difficult conversations with our patients. The target audience is front line, clinical staff who wish to improve or consolidate their communication skills in relation to the consent process or staff who have communication identified  as part of their PDP

Making IRAS work for your Research Amendments (HRA)

The national IRAS and CSP systems (Coordinated System for Gaining NHS Permission for portfolio research) has changed significantly to support researchers submitting Amendments. The aims of the presentation is to ensure that researchers clearly understand the best way to get their amendments for portfolio research working for them i.e. notifying all  participating sites  regarding the changes to their studies. It will give researchers a brief outline of the process in submitting amendments, tips, ideas and workarounds.

Mental Health & Dementia Awareness

For research delivery staff who want a better understanding of mental health and dementia

Monitoring - how to make it pain-free (well,almost)

This session is suitable for any members (new or experienced) of the research site staff team (e.g.Data Managers, Research Nurses, Trial Coordinators) who facilitate on-site monitoring visits. This interactive workshop aims to explain the monitoring process – what do the Monitors do and why?; highlight common monitoring and inspection findings; provide an opportunity to share best practice and explore strategies to avoid findings                                

Paediatric Consent and Communication

All those who undertake paediatric research studies will be involved in the paediatric consent and assent process. The aim of the day is to provide participants with a sound grounding in the standards required when receiving consent and assent in paediatric clinical research. It provides an introductory overview upon which clinical competence can be developed to meet local trust needs and requirements.

Performing Quality Control Checks to Ensure Accurate Data Collection

This course would be suitable for NHS/academic research staff, who would like to develop their skill and confidence in implementing quality control checks, in order to ensure the accuracy of the data and patient safety

Preparing for Audit & Inspection

This course will provide an introduction to the processes involved in inspection, audits and Monitoring and ensure delegate understanding of definitions and reason, implications of non-Compliance, who conducts inspections & R&D audits, the process and what is reviewed, examples of typical findings

Protocol Design

A protocol is the document that specifies the research plan for the clinical trial. It is the single-most important quality control tool for all aspects of a clinical trial. This course will provide attendees with the opportunity to review a protocol template, well designed in compliance with the SPIRIT guidelines. It will in addition provide explanation of the requirements to be included in the individual sections and the reasons for their inclusion.  This course would be suitable for NHS/academic research staff who are involved in the development and review of trial protocols.

Site File Management and Delegation of Duties

The course has been designed to provide delegates with the knowledge required to set up and maintain a Site File, understand the purpose of a Site File, identify the essential documents required and  understand the importance of maintaining a Site File 

Training sessions developed by NIHR for delivery within local Trusts and Organisations

Fundamentals of Clinical Research delivery for ………

These study sessions have been developed by the NIHR, in collaboration with the MHRA, specifically for individuals undertaking limited duties, working to SOPs and instructions. They are designed to be delivered locally, by individuals leading on specific aspects of a study, to enable effective training in both research standards and relevant site and study SOPs concurrently.

  • Fundamentals of Clinical Research delivery for Laboratory Staff
  • Fundamentals of Clinical Research Delivery for Primary Care
  • Fundamentals of Clinical Research Delivery for Pharmacy (Secondary) with IMP
  • Fundamentals of Clinical Research Delivery for Pharmacy (Secondary) without IMP
  • Research Awareness for Pharmacy (Secondary)
  • Fundamentals of Clinical Research Delivery for Pharmacy (Community) with IMP
  • Fundamentals of Clinical Research Delivery for Pharmacy (Community) without IMP
  • Research awareness for Pharmacy (Community)
  • Fundamentals of Clinical Research Delivery for Administering IMPs

Essentials for new Principal Investigators

This course provides a comprehensive overview of the PI role and responsibilities throughout the life-cycle of a study. It also highlights the support and resources available to a PI

PI Oversight Masterclass                                       

The PI Oversight Master Class has been designed specifically for existing PIs to offer practical solutions to enhance effective study oversight and management. Many PIs oversee their studies effectively, but do not always document this. Some may also need to improve their oversight practices. Effective oversight, or evidence of it, is a common finding at monitoring visits and MHRA inspections. This master class aims to provide practical solutions to empower PIs to enhance effective oversight of their studies. The master class 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. The master class is supported by high-quality materials, though is conversational in style rather than power-point or presentation driven. As such  it is important that individuals facilitating the workshop understand the learning approach and have the confidence to lead a discussion based master class. The Master Class is comprised of 5 modules. There are no slides, the course is mainly discussion based around set activities.

Trial Coordinator Masterclass

The masterclass refreshes prior learning through the following modules, Delivering Quality though  Oersight, Data: Rubbish in, rubbish out, Consent is more than just saying ‘Yes’ and Delegate, don’t abdicate, When research goes wrong, and Amendments – can they make or break a study? The masterclass is set up to allow for sharing of best practices between experienced Trial Coordinators.

What you need to know about excess treatment costs (ETCs)

As a result of this course, participants should: Understand what Excess Treatment Costs are, how to identify ETCs, and how ETCs can be managed according to current guidance.  Those attending should have a basic understanding of cost attribution or attended the Cost Attribution Training (AcoRD) delivered by the Network.

 

Writing SOPs -A Workshop

The workshop is organised to enable participants to understand the information a SOP should contain and by the end of the workshop participants will be able to write a SOPs action list, appreciate the need for review and document control  and to write a SOP