Identifying, recording and reporting AEs for clinical ... - Accord

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ACCORD NHS Lothian R&D and The University of Edinburgh SOP Number: CR012v1.0 Effective Date: 14/SEP/2011 1. INTRODUCTION Adverse Device Effects (ADEs) and other safety event identification, recording and reporting procedures will comply with the requirements of the Medical Device Regulations 2002/618 and Good Clinical Practice (GCP). The Investigator will be responsible for identifying and reporting ADEs and other safety events as detailed in this procedure. ACCORD will be responsible for medical device vigilance for Clinical Investigations of Medical Devices (CIMDs) that are sponsored by NHS Lothian and/or the University of Edinburgh (UoE). This responsibility may not be delegated to the Investigator. Where NHS Lothian and/or UoE agrees to co-sponsor a CIMD with another organisation the responsibility for medical device vigilance must be agreed between both organisations before the trial commences and should be clearly documented in a clinical trial agreement or equivalent. 2. PURPOSE To describe the procedure for identifying, recording and reporting AEs and other safety events occurring in CIMDs that are sponsored by NHS Lothian and/or the UoE. 3. SCOPE This SOP applies to clinical researchers participating in CIMDs sponsored by NHS Lothian and/or the University of Edinburgh (UoE). This SOP is also applicable to ACCORD members of staff responsible for medical device vigilance. 4. REFERENCES The Medical Device Regulations (SI: 2002/618) as amended 5. PROCEDURE 5.1 Definitions Adverse Device Effect (ADE) Adverse event related to the use of an investigational medical device. NOTE 1- This includes any adverse event resulting from insufficiencies or inadequacies in the instructions for use, the deployment, the implantation, the installation, the operation, or any malfunction of the investigational medical device. NOTE 2- This includes any event that is a result of a use error or intentional misuse. Adverse Event (AE) Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device. NOTE 1: This includes events related to the investigational device or the comparator. NOTE 2: This includes events related to the procedures involved (any procedure in the clinical investigation plan). Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the latest version Page 2 of 7
ACCORD NHS Lothian R&D and The University of Edinburgh SOP Number: CR012v1.0 Effective Date: 14/SEP/2011 NOTE 3: For users or other persons this is restricted to events related to the investigational medical device. Serious Adverse Event (SAE) Adverse event that: a) led to a death, b) led to a serious deterioration in health that either: 1) resulted in a life-threatening illness or injury, or 2) resulted in a permanent impairment of a body structure or a body function, or 3) required in-patient hospitalization or prolongation of existing hospitalization, or 4) resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function. c) led to fetal distress, fetal death or a congenital abnormality or birth defect. NOTE 1: This includes device deficiencies that might have led to a serious adverse event if a) suitable action had not been taken or b) intervention had not been made or c) if circumstances had been less fortunate. These are handled under the SAE reporting system. NOTE 2: A planned hospitalization for pre-existing condition, or a procedure required by the Clinical Investigation Plan, without a serious deterioration in health, is not considered to be a serious adverse event. Serious Adverse Device Effect (SADE) Any ADE that: • results in death of the clinical investigation participant • is life-threatening* • requires inpatient hospitalisation^ or prolongation of existing inpatient hospitalisation • results in persistent or significant disability or incapacity • consists of a congenital anomaly or birth defect * Life-threatening in the definition of an SADE refers to an event where the participant was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe. ^Any hospitalisation that was planned prior to randomisation will not meet SADE criteria. Any hospitalisation that is planned post randomisation, will meet the SADE criteria. Unanticipated Serious Adverse Device Effect (USADE) Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report. Device Deficiency Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors and inadequate labelling. 5.2 Identifying AEs Parties using this SOP must visit www.accord.ed.ac.uk to guarantee adherence to the latest version Page 3 of 7
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Identifying, recording and reporting AEs for clinical ... - Accord

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