Who will benefit from this presentation?
This course is intended primarily for lab staff but may also be of interest to research nurses and other staff who regularly process bloods and use centrifuges.

What will I learn?
Labs that analyse samples from Clinical Trials of Investigational Products (CTIMPs) i.e. drugs or devices must comply with the principles of GCLP and such labs are open to inspection by the Medicines and Healthcare Products Regulatory Authority (MHRA). However, it is desirable for the staff in any lab that handles human samples to be aware of GCLP and comply as far as possible. This course, is based on the MHRA's document "Good Clinical Practice: Guidance on the maintenance of regulatory compliance in laboratories that perform the analysis or evaluation of clinical trials" which can be found on their website.

This course provides an informal but intensive overview of the process of applying for ethical approval. It will cover what types of projects require ethical approval, common ethical issues observed in applications, give an overview of the IRAS form and all approvals required before research can begin.

Who will benefit from this course?
Any researcher involved in studies that do not involve investigational medicinal products (IMP’s) e.g. observational, qualitative, research using blood or tissue, analysis of data from medical notes (and many more).

What will I learn? This course will cover the Research Governance Framework and the principles of Good Clinical Practice. Topics covered by the course include:
- The roles & responsibilities of those involved in research.
- The informed consent process
- Documentation required and the contents of a study site file.
- Quality assurance aspects of running a study, e.g. SOP’s, monitoring and fraud and misconduct.

This course provides an informal but intensive overview of the process of applying for ethical approval. It will cover what types of projects require ethical approval, common ethical issues observed in applications, give an overview of the IRAS form and all approvals required before research can begin.

This course provides an informal but intensive overview of the process of applying for ethical approval. It will cover what types of projects require ethical approval, common ethical issues observed in applications, give an overview of the IRAS form and all approvals required before research can begin.

Who will benefit from this course?
Any researcher involved in studies that do not involve investigational medicinal products (IMP’s) e.g. observational, qualitative, research using blood or tissue, analysis of data from medical notes (and many more).

What will I learn? This course will cover the Research Governance Framework and the principles of Good Clinical Practice. Topics covered by the course include:
- The roles & responsibilities of those involved in research.
- The informed consent process
- Documentation required and the contents of a study site file.
- Quality assurance aspects of running a study, e.g. SOP’s, monitoring and fraud and misconduct.

Who will benefit from this course?
Any researcher involved in studies that do not involve investigational medicinal products (IMP’s) e.g. observational, qualitative, research using blood or tissue, analysis of data from medical notes (and many more).

What will I learn? This course will cover the Research Governance Framework and the principles of Good Clinical Practice. Topics covered by the course include:
- The roles & responsibilities of those involved in research.
- The informed consent process
- Documentation required and the contents of a study site file.
- Quality assurance aspects of running a study, e.g. SOP’s, monitoring and fraud and misconduct.

This course provides an informal but intensive overview of the process of applying for ethical approval. It will cover what types of projects require ethical approval, common ethical issues observed in applications, give an overview of the IRAS form and all approvals required before research can begin.