Research Governance and GCP Flashcards
What is the definition of governance in the context of research?
Governance refers to the act or process of overseeing and controlling something, which can include corporate entities, institutions, policies, processes, projects, and people. It ensures research is safe, follows the law, is of good quality, and benefits people, especially in research involving humans.
What is the role of research governance and Good Clinical Practice (GCP)?
Research governance and Good Clinical Practice (GCP) protect research participants’ rights, safety, and welfare, ensuring data quality and integrity. This maintains trust, accountability, and transparency in research. GCP also simplifies and harmonizes administrative procedures through international standards set by the International Council for Harmonisation (ICH).
Name three key pieces of legislation relevant to research governance.
UK Medicines Act (1968) and subsequent amendments.
General Data Protection Regulations (2018).
Human Tissue Act (2004).
What documents are required for approval to conduct a clinical trial?
To conduct a clinical trial, the following documents are required:
Protocol
Participant Information Sheet
Informed Consent Form
Integrated Research Application System (IRAS) forms
Investigator’s Brochure (if an Investigational Medicinal Product (IMP) is involved)
What is the role of a sponsor in clinical research?
The sponsor is the organization responsible for the management and indemnity of the research. All clinical research in the UK must have a sponsor, which can be either a commercial sponsor (such as a pharmaceutical company) or a non-commercial sponsor (like an academic institution or NHS trust).
What is required for clinical trial applications in the NHS?
For clinical trial applications involving NHS patients, staff, premises, or tissue samples, the Integrated Research Application System (IRAS) is used. The application is reviewed by governance, legal compliance bodies, and research ethics committees before final approval is granted.
What steps are involved in research approval after regulatory approval?
After regulatory approval, the following steps are involved:
Local research site approval, including feasibility assessments, contracts, and funding.
Study amendments, re-review by regulatory authorities, and local research governance.
Progress reports, annual updates, study close-out, and final study reports.
Public disclosures of study design, progress, and results.
What does Good Clinical Practice (GCP) ensure in clinical trials?
Good Clinical Practice (GCP) ensures the ethical and scientific quality of clinical trials, protecting participants’ rights, safety, and well-being. It ensures that data is credible and accurate, following a clear and detailed protocol for design, conduct, performance, monitoring, auditing, and reporting.
What are the 13 principles of Good Clinical Practice (GCP)?
The 13 principles of GCP are:
Ethical principles based on the Declaration of Helsinki.
Benefits should outweigh the risks for participants and society.
Participants’ rights, safety, and well-being take precedence.
Adequate clinical and non-clinical information supports the trial.
The trial should be scientifically sound and clearly described.
Conducted according to an ethically approved protocol.
Care must be provided by qualified professionals.
Trial staff should be properly trained.
Participants must give informed consent.
Data should be accurately reported and verified.
Participant confidentiality must be maintained.
Medicines must comply with Good Manufacturing Practice (GMP).
Systems should assure quality in every aspect of the trial.
What types of training are required to conduct clinical research?
Training for conducting clinical research includes:
GCP (Good Clinical Practice)
Human Tissue Act (HTA)
Policies and standard operating procedures at the research site
Clinical trial-specific training Academic institutions typically provide GCP or HTA training, which is renewed every 2 years.
How does a sponsor ensure compliance with GCP?
Sponsors ensure compliance with GCP by auditing investigator sites for quality assurance. Audits can be random or for specific causes and are often conducted in preparation for inspections. Additionally, sponsors must notify the MHRA of any serious breaches, and the MHRA may inspect trial sites based on risk assessments.
What is the role of the MHRA in clinical trials?
The MHRA (Medicines and Healthcare products Regulatory Agency) is responsible for ensuring compliance in clinical trials, particularly when Investigational Medicinal Products (IMPs) are involved. It reviews clinical trial applications, conducts inspections, and ensures adherence to regulations, including assessing breaches and reviewing marketing authorization.
What is the purpose of the Integrated Research Application System (IRAS) in clinical trials?
The Integrated Research Application System (IRAS) is used for submitting research applications involving NHS patients, staff, premises, or tissue samples. It helps streamline the process by integrating multiple approval pathways, including governance, legal compliance, and research ethics committees.
What are the obligations of sponsors and trial sites under GCP?
Sponsors and trial sites are obligated to ensure that clinical trials are conducted according to GCP guidelines, including proper training of staff, maintaining participant safety, and ensuring accurate and verifiable data. They must also conduct audits and notify the MHRA of any serious breaches.
How are clinical trials impacted by Brexit, particularly in relation to the EU Clinical Trials Directive?
After Brexit, the EU Clinical Trials Directive was amended to align with UK regulations, particularly the Medicines for Human Use (Clinical Trials) Regulations (2004) and the subsequent amendment in 2019. This shift requires adjustments to clinical trial applications and procedures to ensure compliance with UK law instead of EU law.
What is the role of local feasibility assessments in clinical research?
Local feasibility assessments are conducted after regulatory approval to evaluate the practicality of conducting the study at a particular site. These assessments include securing contracts, funding, and ensuring that the necessary staff and space are available. This step is typically the final hurdle before study initiation.
What should happen when there are study amendments during a clinical trial?
When study amendments occur, they must be re-reviewed by both regulatory authorities and local research governance bodies. This ensures that the changes comply with ethical and legal requirements. Additionally, progress reports and updates need to be provided during and after the amendment process.
What is the importance of public disclosures in clinical research?
Public disclosures are important for maintaining transparency and accountability in clinical research. They provide information about the study design, progress, and results, helping to ensure that the research process is open to scrutiny and that the outcomes are communicated to the public.
