This excellent half day course introduces new skills and knowledge to even the most experienced clinical research staff and is highly recommended! Do you introduce clinical trials to patients/ participants? Do you receive consent for clinical trials? Then you need to do the Let’s Talk Trials training
To understand the historical context of archiving, importance of archiving, regulatory & legal frameworks, rrchiving challenges and meeting archiving challenges
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.
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 the definitions, process and reasons for audits and inspections and the implications of non-compliance.
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
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.
A combination of presentations discussion groups and activities focused around scenarios relating to clinical trial delivery within pharmacy
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.
Participants will understand the significance of data management and collection, understand the importance of CRF design, development and completion and understand the role of data management in quality assurance, leading to publication
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. Attendees will be asked to make short and long terms pledges about how they will involve and engage with patients and the public in the future, in order to raise awareness about research and improve deliverability about research.
This 2hr course is aimed at new Principal Investigators (within first 18 months or first few studies) and people interested in becoming 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.
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
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.
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.
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