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1、QUALITY MANAGEMENT SYSTEMPROCEDUREClinical Trail ProcedureContentsSN TextPage1.0Purpose22.0Scope23.0 Forms and Attachments24.0References25.0Abbreviations and Denitions26.0Responsibilities27.0Safety Precautions38.0Clinical Sites 39.0Testing Requirements410.0Documentation Maintenance411.0Final Report4
2、1.0 PurposeThe purpose of this SOP is to define the procedure for conducting clinical trials that involves the participation of human subjects.2.0 ScopeThis procedure is applicable to all personnel involved in clinical trials conducted at LYSUN Biotech (Hangzhou) Co., LTD.3.0 Forms and AttachmentsAt
3、tachment 1 Clinical Study Protocol - SampleAttachment 2 Specimen Procurement Outline - Sample4.0 ReferencesBS EN 540:1993 Clinical Investigation of Medical Devices for Human SubjectsBS EN 13612:2(X)2 Performance Evaluation of In Vitro Diagnostic Medical DevicesEN ISO 14155-1:2003 Clinical Investigat
4、ion of Medical Devices for Human SubjectsQP()8() Design Control ProcedureQR220 Vigilance Procedure5.0 Abbreviations and DefinitionsCSClinical StudyCTSEuropean Unions Common Technical SpecificationsMDRMedical Device ReportGCPGood Clinical PracticeIVDIn-Vitro DiagnosticR&DResearch & DevelopmentInt,l R
5、A International Regulatory AffairsPL/CRC Project LeaderZClinical Research CoordinatorQA Quality Assurance6.0 Responsibilities6.1 Initiator of the DocumentInfI RA representative is responsible for initiating changes to this procedure.6.2 Approval of Changes to the ProcedureThe Quality Assurance Manag
6、er shall approve this procedure.6.3 Notification of Changes to this ProcedureAfter approval, the Document Control Coordinator shall notify all area management when the document has been released.6.4 ExecutionThe InfI RA , R&D, Marketing representative or designee is responsible for the execution of
7、this document.6.5 Area management is responsible for providing adequate training based on the training matrix.6.6.PL/CRC6.5.1 The PL/CRC is responsible to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol and applicable regulatory require
8、ments.6.5.2 The PL/CRC is responsible for securing agreement from involved parties to ensure access to all trial related sites, source data, and reports for the purpose of monitoring and auditing by LYSUN bio and regulatory authorities.6.5.3 The PL/CRC is responsible for applying quality control at
9、each stage of the clinical trial to ensure that all records and data are reliable and have been processed correctly.6.5.4 The PL/CRC is responsible to submit if applicable any required applications to the appropriate authorities for review, acceptance and/or permission to begin a clinical trial. Any
10、 notification/submission should be dated and contain sufficient information to identify the protocol and approval of the informed consent form.6.5.5 The PL/CRC monitors the status of the clinical study to ensure the team is progressing toward the completion of the activity.6.5.6 The PL/CRC is respon
11、sible for prioritizing and scheduling the activities needed to reduce or eliminate the potential adverse events.6.5.7 The PL/CRC is responsible for ensuring that all approved clinical study forms, protocols, are accurately completed. (See Attachments).6.7 QA6.7.1 QA is responsible for maintaining th
12、e clinical study records.7.1 Safety PrecautionsLYSUN is liable to all the participants on body injuries caused by the clinical study. There are no other safety precautions associated with this procedure.7.2 Clinical Sites8.1 Clinical sites are selected by the clinical study team.8.2 Clinical sites m
13、ust meet all regulatory requirements.8.3 When determining the location of where the clinical trials will be conducted, the ethnicity of the population must be considered to ensure the population sampling is equivalent to the populations where the product will be distributed. It must be determined if
14、 the population selected is representative of the user population. Clinical study sites should be selected based on population the test is intended for and also to satisfy CTS requirements for CE marked products.9.0 Testing Requirements9.1 The testing requirements for each project may vary depending
15、 on the product/product classification.9.2 The clinical data obtained from the clinical trial will be analyzed through appropriate statistical analysis software.10.0 Documentation of CommunicationI ().1 Once the study has concluded, the protocols and other associated records will be submitted to Doc
16、ument Center for maintenance. Records will be maintained for at least 2 years from when the clinical trial has been completed, terminated or from the date that market approval has been obtained.11.0 Final ReportILlA Final report shall be generated al the conclusion of the study.11.2 The Final Report shall summarize the data and state conclusions from the study.11.3 The conclusion shall specifically state if the product is “saf and effective fbr the intended uses.文件修改履历Document History Summary修改后版本或 页码修改号Updated Version Or Page Revision更改单 编号DCR Ref更改概述 Summary of Changes生效日期Effective Dale
