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 process which will include a webinar demonstrating the functionality of the tool. 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.
Training will be delivered to a maximum group size of 10 to ensure everyone has the opportunity to share their opinions and ask and answer questions.
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
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
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
A Workshop aimed at pharmacy staff to consolidate their learning from the GCP for Management online course by understanding the context of clinical trials in a pharmacy dept, sharing best practice examples, problem solving and risk management in trial set up and delivery
The course will include a mixture of short presentations and activities, which will provide an overview rather than an in-depth understanding.
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
Attendees 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 events and be able to implement local SAE reporting procedures
Attendees will be able to understand 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 and the taining requirements for personnel
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.
This course aims to ensure that researchers clearly understand the best way to get their amendments for portfolio research working for them, giving a brief outline of the process in submitting amendments, tips, ideas and workarounds with an emphasis on HRA processes and how these now need to be considered when planning your amendment submissions
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 will give attendees the opportunity to explore differences and challenges involved with paediatric research in a NHS setting
At the 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
This course will provide an introduction to the processes involved in inspection, audits and monitoring
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.
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.
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