Clinical Trail Procedure （英文版）临床评估控制程序

1、QUALITY MANAGEMENT SYSTEM PROCEDUREClinical Trail Procedure ContentsSN Text Page1.0 Purpose22.0 Scope .23.0 Forms and Attachments. 24.0 References.25.0 Abbreviations and Definitions26.0 Responsibilities.27.0 Safety Precautions38.0 Clinical Sites 39.0 Testing Requirements.4 10.0 Documentation Mainten

2、ance411.0 Final Report 4 1.0PurposeThe 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

3、Forms and Attachments Attachment 1Clinical Study Protocol - SampleAttachment 2Specimen Procurement Outline - Sample4.0ReferencesBS EN 540:1993Clinical Investigation of Medical Devices for Human SubjectsBS EN 13612:2002Performance Evaluation of In Vitro Diagnostic Medical DevicesEN ISO 14155-1:2003Cl

4、inical Investigation of Medical Devices for Human SubjectsQP080Design Control ProcedureQR220Vigilance Procedure5.0 Abbreviations and DefinitionsCS Clinical StudyCTS European Unions Common Technical Specifications MDR Medical Device ReportGCP Good Clinical PracticeIVD In-Vitro DiagnosticR&D Resea

5、rch & DevelopmentIntl RA International Regulatory Affairs PL/CRC Project Leader/Clinical Research CoordinatorQA Quality Assurance 6.0 Responsibilities6.1Initiator of the DocumentIntl RA representative is responsible for initiating changes to this procedure.6.2Approval of Changes to the Procedure

6、 The Quality Assurance Manager shall approve this procedure.6.3Notification of Changes to this ProcedureAfter approval, the Document Control Coordinator shall notify all area management when the document has been released.6.4Execution The Intl RA , R&D, Marketing representative or designee is re

7、sponsible for the execution of this document.6.5Area management is responsible for providing adequate training based on the training matrix. 6.6.PL/CRC6.6.1 The PL/CRC is responsible to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol an

8、d applicable regulatory requirements.6.6.2 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.6.6.3 The PL/CRC is responsible f

9、or applying quality control at each stage of the clinical trial to ensure that all records and data are reliable and have been processed correctly.6.6.4 The PL/CRC is responsible to submit if applicable any required applications to the appropriate authorities for review, acceptance and/or permission

10、 to begin a clinical trial. Any notification/submission should be dated and contain sufficient information to identify the protocol and approval of the informed consent form.6.6.5 The PL/CRC monitors the status of the clinical study to ensure the team is progressing toward the completion of the acti

11、vity.6.6.6 The PL/CRC is responsible for prioritizing and scheduling the activities needed to reduce or eliminate the potential adverse events.6.6.7 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

12、 responsible for maintaining the clinical study records.7.0Safety 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. 8.0Clinical Sites8.1 Clinical sites are selected by the clinical s

13、tudy team. 8.2 Clinical sites must 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 distri

14、buted. It must be determined if 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.9.0Testing Requirements9.1 The testing requirements for e

15、ach project may vary depending 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 Communication10.1 Once the study has concluded, the protocols and other associated rec

16、ords will be submitted to Document 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 Report11.1 A Final report shall be generated at the conclusion of the study.11.2 The Final Report shall summarize the data and state con