Training and Workshops

Aims and objectives

This training session will help you to:

1. Understand the requirements that may need to be in place for you to use human tissue for research
2. Understand instances where the storage or use of human tissue for your research may not be appropriate

Target audience

You will be a researcher or a member of professional services staff involved in clinical research projects that use human tissue. You would like to gain a better understanding of the requirements surrounding the use of human tissue in clinical research projects.

Please note this training course is only open to University of Birmingham Staff and Postgraduate Students.

Why this course?

The use of human tissue is essential to many research projects in the UoB portfolio. Understanding the regulations around what needs to be in place to use and store this tissue is an essential part of such projects. This course will provide an overview of what the requirements are.

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An online self-study session for staff who are involved in clinical trials who may be selected for an internal UoB audit, carried out by the Clinical Research Compliance Team (CRCT). The session will highlight what happens before, during and after an internal audit

Aims and objectives

This training session will help you to:

• prepare for the audit visit
• understand what will happen during the audit visit
• understand how the audit is reported, and what happens afterwards
• set effective corrective and preventative actions (CAPA)
  

  Target audience:

  You will be a researcher, or a member of professional services staff involved in clinical trials that may be selected for an audit. You would like to gain a better understanding of what you need to do before an audit, and what happens during and after the visit.

  Please note this training course is only open to University of Birmingham Staff and Postgraduate Students 

Why this course? 

A greater understanding of the audit process will help the audit run smoothly for the benefit of the auditees, as well as the auditor. It will ensure that the auditee feels prepared and is able to capitalize on the audit, as audits can help identify areas of  non-compliance and weaknesses in processes. By identifying them, corrections can be made, recurrence can be prevented and processes can be improved. 

Aims and objectives

The data generated from a clinical trial plays a fundamental role in determining the outcome of a trial and subsequently the direction of future research/treatments. It is therefore vital that the data management processes are robust enough to ensure that the data being collected and reported is to the highest of standards, accurately reflecting the research being carried out. In this session we will discuss the regulations, standards and UoB requirements for data management that are applied to clinical trials at UoB.

Target audience:

You will be a member of professional services staff or a researcher involved in clinical research being run at UoB, and you would like to gain a better understanding of the processes surrounding data management. Registration is required to attend this training course.

Why this course:

This course will help you understand what is required in terms of the data management process and where to find guidance.  

Feedback:

• Good overview and reminder of requirements
• Signposting to SOPs
• Comprehensive review; especially good for those new to data management
• Provided a good overview of the SOP and how to use it
• Very informative
• Covered a diverse range of things connected to Data Management
• Opportunities to ask questions

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Event details

This training session is applicable to staff involved in the handling, processing, receipt, storage or analysis of human biomaterial that is defined as ‘Relevant Material’ by the Human Tissue Act. The session will provide an introduction to the Human Tissue Act and an overview of the UoB Clinical Research in the Laboratory Standard Operating Procedures (SOPs) applicable to working with human biomaterial. In the session we will discuss the required laboratory and sample management processes.

 This session is aimed at those working on clinical studies rather than trials. Staff working with clinical trial samples, please attended the Clinical Research in a University of Birmingham Laboratory training session. Please note, due to overlap in content you do not need to attend both training sessions.

Aims and objectives:

This training session will provide:

• An introduction to the Human Tissue Act
• An overview of the UoB Clinical Research in the Laboratory Standard Operating Procedures (SOPs) applicable to working with human biomaterial
• Details of the required laboratory and sample management processes

Target audience:

This training session is applicable to staff who are working on clinical studies which involve the handling, processing, receipt, storage and/or analysis of human tissue that is defined as ‘Relevant Material’ by the Human Tissue Act.

Why this course:

This training session will cover the content of the relevant SOPs in detail to provide researchers with the tools they need to work to the Human Tissue Standard in the laboratory.

Feedback:

• ‘A really helpful and clearly presented session’
• ‘The course is very well structured and helpful. In particular, I found it very well explained the meaning of relevant material, the law that regulates it and its full pathway: from consent to storage’.

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Aims and objectives:

Essential documents individually and collectively permit evaluation of the conduct of clinical research and the quality of the data produced.

This course explores the process for the development, review, implementation and filing of essential documents involved in clinical research conducted at the University of Birmingham (UoB).

Target audience:

You will be a researcher involved in clinical research being run at UoB, and you would like to gain a better understanding of the process for developing, reviewing, implementing and filing essential documents in clinical research.

Why this course:

This course will cover the requirements for the development of the protocol, participant information sheet (PIS), informed consent form (ICF), case report form (CRF) and investigator brochure (IB). It will also outline examples of other documents that are essential for reconstruction of the project conduct.

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Aims and objectives:

The aim of this course is to explain the process for obtaining the necessary approvals and authorisations required before recruitment to clinical research can begin and the process for making amendments to a project.  

This course will outline the procedures for setting up a clinical research project with the necessary approvals to be conducted within the University of Birmingham (UoB). This includes obtaining sponsorship, a favourable opinion from a research ethics committee (REC), Health Research Authority (HRA) approval and Medicines & Healthcare products Regulatory Agency (MHRA) authorisation and also how to make amendments.

Target audience:

You will be a researcher involved in clinical research being run at UoB, and you would like to gain a better understanding of the process for obtaining sponsorship, ethics and external approvals and amendments.

Why this course?

This course will cover the requirements for obtaining approvals and authorisations prior to recruitment to clinical research and the process for making amendments to a project.

Feedback

• Good overview of project set-up process for someone new
• Good overview of the different teams and their roles in project set-up
• This training session gives out important information and essential elements that are required for setting up a clinical research project

Register to access the course