Research Governance Framework. RGF RGT See Governance Team’. ‘Research See Safety Information’. RSI ‘Reference See Adverse Event’. SAE ‘Serious See Form’. SAF ‘Self-Assessment See Adverse Reaction’. SAR ‘Serious SDV See Data Verification’. ‘Source A correction to the CRF that can be made by the sponsor without Self Evident Correction the requirement for a referral of a data clarification to the investigator. UoB Ethical Review of Research Self-Assessment Form. Self-Assessment Form (SAF) Any untoward medical occurrence or effect that at any dose: Serious Adverse Event (SAE) Results in Is life threatening* Requires hospitalisation or prolongation of existing inpatients’ hospitalisation Results in persistent or significant disability or incapacity Is a congenital anomaly/birth defect Or is otherwise considered medically significant by the Investigator** Comments: The term severe is often used to describe the intensity (severity) of a specific event. This is not the same as serious, which is based on participants/event outcome or action criteria. * Life threatening in the definition of an SAE refers to an event in which the participant was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if it were more severe. ** Medical judgment should be exercised in deciding whether an AE is serious in other situations. Important AEs that are not immediately life threatening or do not result in death or hospitalisation but may jeopardise the subject or may require intervention to prevent one of the other outcomes listed in the definition above, should be considered serious. For CTIMPs, an adverse reaction which also meets the definition of Serious Adverse Reaction a Serious Adverse Event. (SAR) A hospital, health centre, surgery or other establishment or facility in Site the UK at or from which a CTIMP, or any part of a CTIMP, is conducted. The Site File contains all essential documents held by Principal Site File Investigator(s) conducting a trial which individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced. Note: this is sometimes known as the Investigator Site File or ISF. See of Product Characteristics’. SmPC ‘Summary
RGF Research Governance Framework. RGT See ‘Research Governance Team’. RSI See ‘Reference Safety Information’. SAE See ‘Serious Adverse Event’. SAF See ‘Self-Assessment Form’. SAR See ‘Serious Adverse Reaction’. SDV See ‘Source Data Verification’. Self Evident Correction A correction to the CRF that can be made by the sponsor without the requirement for a referral of a data clarification to the investigator. Self-Assessment Form (SAF) UoB Ethical Review of Research Self-Assessment Form. Serious Adverse Event (SAE) Any untoward medical occurrence or effect that at any dose: Results in Is life threatening* Requires hospitalisation or prolongation of existing inpatients’ hospitalisation Results in persistent or significant disability or incapacity Is a congenital anomaly/birth defect Or is otherwise considered medically significant by the Investigator** Comments: The term severe is often used to describe the intensity (severity) of a specific event. This is not the same as serious, which is based on participants/event outcome or action criteria. * Life threatening in the definition of an SAE refers to an event in which the participant was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if it were more severe. ** Medical judgment should be exercised in deciding whether an AE is serious in other situations. Important AEs that are not immediately life threatening or do not result in death or hospitalisation but may jeopardise the subject or may require intervention to prevent one of the other outcomes listed in the definition above, should be considered serious. Serious Adverse Reaction (SAR) For CTIMPs, an adverse reaction which also meets the definition of a Serious Adverse Event. Site A hospital, health centre, surgery or other establishment or facility in the UK at or from which a CTIMP, or any part of a CTIMP, is conducted. Site File The Site File contains all essential documents held by Principal Investigator(s) conducting a trial which individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced. Note: this is sometimes known as the Investigator Site File or ISF. SmPC See ‘Summary of Product Characteristics’.
UoB-CLN-CTM-QCD-001-Glossary-of-Terms-v3.0-dd.-28-Jan-16.docx