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.
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
The training will provide an overview of the arrangements for the new process which will include the challenges and benefits of the new system. The training will discuss the requirements of the SoECAT, timescales, and the responsibility of the sponsor as well as the role of the AcoRD Specialist in authorising the SoECAT. The training will also discuss ETCs and go through some examples to illustrate the new process. It is expected that those attending will already have completed our cost attribution training or have some background knowledge of the DHSC AcoRD Guidance to support their learning.
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 provides a comprehensive overview of the PI role and responsibilities throughout the lifecycle of a study. It also highlights the support and resources available to a PI
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.
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
Please note there are now 2 sessions linked with the Feasibility Workshop. Session 1 focuses on Feasibility and Session 2 on Performance Management & Monitoring. You are not required to sign up to both sessions
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
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 and employ checks to ensure patient safety
The course will include a mixture of short presentations and activities, which will provide an overview rather than an in-depth understanding.