The link to the course.
Clinical Trials of Investigational Medicinal Products (CTIMPs)
Studies that do not involve an investigational medicinal product (IMP) are known as Non-CTIMPs.
The department of Health’s Research Governance Framework for Health and Social Care (2005) is in place to set out the standards for all clinical research conducted in the NHS England.
Standards which apply to all research
Research Governance Framework
The Department of Health’s Research Governance Framework for Health and Social Care (2005) requires that all research conducted in the NHS is done to the same high standard, no matter what the focus or methodology.
ICH Good Clinical Practice (GCP)
The ICH Guideline for Good Clinical Practice E6 (R1) (1996), and the Declaration of Helsinki (1996 version) which it references, are key documents upon which all later guidance and legislation have been based. They continue to support the conduct of high quality, credible clinical research.
Overarching UK Laws
There are overarching regulations that apply in any context and to all studies, such as the Data Protection Act (1998) and Freedom of Information Act (2000).
Local policies and SOPs
Your NHS Trust may also have local policies around how these are implemented or standard operating procedures (SOPs) which detail how specific research activities should be carried out locally which you must follow.
Study specific requirements
The study Sponsor will detail study specific requirements in the Protocol and supporting documentation.
Study specific training may also be provided.
Vulnerable Participants and Regulated Procedures
If you are involving vulnerable participants in research, or using a regulated procedure, there may be additional regulations and guidance in place to protect them. You only need to take these very specific requirements into account if they apply to your research, but it is essential that you do so where
Study Setup and Responsibilities
three key roles:
- Sponsor (management and finance of study, can be an organization or single/group of people)
- Chief Investigator (CI) (conduct of the study)
- Principal Investigator (PI) (initiation and conduct of the study at Site)
2 Protocol’s supporting documents:
- instructions for the study procedures
- patient information sheets – ethical approval
- blank consent forms
- blank case report forms
- templates for letters of invitation
3 Training Records and CVs
4 Letters of Approval relating to the study
Documents related to this training
Module Summary 4 – The Process of Informed Consent
Module Summary 3 – Study Set-up and Responsibilities
Module Summary 2 – GCP and Standards in Research
Module Summary 5 – Data Collection and Documentation
Module Summary 6 – Safety Reporting
Decision Tree for Adverse Event Reporting