As a result of this course, participants will be able 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 eventsand be able to implement local SAE reporting procedures
The aim of the session is to share good practice, ideas and tips for the completion of effective Assess, Arrange and Confirm processes at Trust Level.
The aim of this Workshop is to provide participants with a sound grounding in the standards required when receiving consent in clinical research. It provides an introductory overview upon which clinical competence can be developed to meet local Trust needs and requirements.
This course will give attendees the opportunity to explore differences and challenges involved with paediatric research in a NHS setting
The PI Oversight Master Class is designed to support the ongoing development of experienced PIs and focuses on effective oversight of the studies participants are responsible for
Using a mix of presentations and activities, delegates will learn about the purpose of a Site File; what are the Essential Documents; maintenance of the Site File and how to set up a Site File
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. The session has an interactive activity looking at the steps involved in obtaining ready to recruit confirmation from each of the organisations involved in your study.
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.
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.
To undestand the reasons for Archiving; the Responsibilities – who should be doing what; How the EU directive on clinical trials has influenced the requirements for retention and the required documents; The difference between archiving and storage; How electronic records fit into the archiving requirements;Training requirements for personnel
The course will include a mixture of short presentations and activities, which will provide an overview rather than an in-depth understanding. Additional reading and resources for each topic will be provided
The workshop is organised to enable participants to understand the information a SOP should contain. At end of the workshop participants will be able to write a SOPs action list, appreciate the need for review and document control and write a SOP
The course will through a mixture of presentation, discussion and activities ensure delegates understand definitions and reasons – Why?; Implications of non-compliance; Inspections -who conducts, process and what is reviewed, Examples of typical findings and R&D Audits -Who conducts; Selection Process and Overview of process
This study session aims to give participants an understanding of the monitoring process – what do the Monitors do and why?; some common monitoring and inspection findings and some strategies to avoid findings
By the end of this workshop participants will be able to define the purpose and discuss the benefits of performing quality control checks on research data; implement strategies to ensure compliance with the appropriate regulations and research protocol; put into practice techniques to ensure that the data and essential documents are accurate; employ checks to ensure patient safety
This workshop aims to support health, research and development staff understand all aspects of the feasibility process and provide hints and tips as to what constitutes a good feasibility.
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
The workshop will enable you to Clarify and develop understanding of the role of the facilitator; Identify and practice key skills of facilitation; Increase awareness and understanding of methods and techniques to manage groups and use within participatory group sessions; Explore difficulties that may arise in group/ sessions and strategies to deal with them
A combination of presentations discussion groups and activities focused around scenarios relating to clinical trial delivery within pharmacy
This study session will assist you to enhance communication with your Patients by establishing the elements that constitute a FULL discussion of participation, help you to employ an interview structure that ensures each element is covered; to identify and utilise communication skills required to move through the interview structure to ensure fully informed consent and to help overcome some of the difficulties associated with approaching patients for clinical studies
This course is aimed at Trial Coordinators who are responsible for the set-up, coordination and management of an entire study for a Chief Investigator. This course is not designed for research staff who are involved in study set up for a Principal Investigator.
The masterclass is set up to refresh prior learning and to share best practices involved in the coordination of trials