A study for which the overall study management is under the responsibility of Investigator an independent Chief Investigator. Specific tasks may be delegated to a managed study member of his/her team or to a CTU. Integrated Research Application System; set up to streamline the research IRAS application process in the UK IRMER The Ionising Radiation (Medical Exposure) Regulations 2000 Investigator Site File ISF See Response System’ IVRS ‘Interactive See Web Response System‘ IWRS ‘Interactive College of Life and Environmental Sciences LES Marketing Authorisation MA Marketing Authorisation Holder MAH Manager A person within the UoB who takes on line management responsibilities. This is typically an academic related or support staff function. College of Medical and Dental Sciences MDS Mentorship Clinical Trials Unit (CTU) mentorship is defined as an informal and professional relationship between an Independent Chief Investigator and/or their research team and one of the three UKCRN registered UoB CTUs, whereby there is an informal transmission of clinical experience, knowledge, skills, information and perspective imparted from the UoB CTU to the Independent Chief Investigator and/or their research team. The UoB CTU will not act in a supervisory capacity and the ultimate responsibility for the conduct of a trial will lie with the Independent Chief Investigator. Where CTU mentorship is agreed upon, this will be documented. Where the UoB CTU feels their mentoring provision is ignored, leaving the Sponsor open to risks, they may choose to discuss this directly with the Sponsor. Medicines and Healthcare products Regulatory Agency; the Competent MHRA Authority in the UK Marketing and Importation Authorisation for IMPs MIA(IMP) National Institute for Health Research NIHR NIHR CRN National Institute for Health Research Clinical Research Network NIHR Coordinated System for gaining NHS Permission NIHR CSP In accordance with Directive 2001/20/EC, a non-commercial clinical trial is Non-commercial defined as a trial: Clinical trial Conducted by a non-commercial organisation, with no industry □ sponsor, that is not part of the development program for a marketing authorisation of a medicinal product; or, If potentially leading to a marketing application, where the holder of the □ intellectual property/patent is a not-for-profit organisation Any clinical trial which is not a CTIMP Non-CTIMP Medicinal products supplied to subjects participating in a trial, used in accordance with the protocol, which do not fall under the definition of IMPs in Directive 2001/20/EC. Medicinal Product
Investigator managed study A study for which the overall study management is under the responsibility of an independent Chief Investigator. Specific tasks may be delegated to a member of his/her team or to a CTU. IRAS Integrated Research Application System; set up to streamline the research application process in the UK IRMER The Ionising Radiation (Medical Exposure) Regulations 2000 ISF Investigator Site File IVRS See ‘Interactive Response System’ IWRS See ‘Interactive Web Response System‘ LES College of Life and Environmental Sciences MA Marketing Authorisation MAH Marketing Authorisation Holder Manager A person within the UoB who takes on line management responsibilities. This is typically an academic related or support staff function. MDS College of Medical and Dental Sciences Mentorship Clinical Trials Unit (CTU) mentorship is defined as an informal and professional relationship between an Independent Chief Investigator and/or their research team and one of the three UKCRN registered UoB CTUs, whereby there is an informal transmission of clinical experience, knowledge, skills, information and perspective imparted from the UoB CTU to the Independent Chief Investigator and/or their research team. The UoB CTU will not act in a supervisory capacity and the ultimate responsibility for the conduct of a trial will lie with the Independent Chief Investigator. Where CTU mentorship is agreed upon, this will be documented. Where the UoB CTU feels their mentoring provision is ignored, leaving the Sponsor open to risks, they may choose to discuss this directly with the Sponsor. MHRA Medicines and Healthcare products Regulatory Agency; the Competent Authority in the UK MIA(IMP) Marketing and Importation Authorisation for IMPs NIHR National Institute for Health Research NIHR CRN National Institute for Health Research Clinical Research Network NIHR CSP NIHR Coordinated System for gaining NHS Permission Non-commercial Clinical trial In accordance with Directive 2001/20/EC, a non-commercial clinical trial is defined as a trial: □ Conducted by a non-commercial organisation, with no industry sponsor, that is not part of the development program for a marketing authorisation of a medicinal product; or, □ If potentially leading to a marketing application, where the holder of the intellectual property/patent is a not-for-profit organisation Non-CTIMP Any clinical trial which is not a CTIMP Medicinal Product Medicinal products supplied to subjects participating in a trial, used in accordance with the protocol, which do not fall under the definition of IMPs in Directive 2001/20/EC.
UoB-CLN-CTM-QCD-001%20Glossary%20of%20Terms%20v2.0.docx