Overview <Provide a brief overview about the SOP> Purpose <Describe the purpose of the work or process.> Scope <Outline the scope and limits of the SOP.> Guiding Principles <Reference any sources and legislation that are relevant to the procedure. In particular referencing the relevant International Conference on Harmonisation documentation on Good Clinical Practice and the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research is recommended. An example is provided below: > Research studies should be conducted in accordance with applicable legislation and regulatory standards. Thus, this document has been guided by the following resources: International Conference on Harmonisation documentation on Good Clinical Practice (ICH-GCP, ) and the Therapeutic Goods Administration (TGA) annotated version (). the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (henceforth referred to as the statement’, ), ‘national The Australian Code for the Responsible Conduct of Research (), Therapeutic Goods Administration’s Australian Clinical Trial Handbook (), and Declaration of Helsinki (). Definitions and Abbreviations <Define any specialized or unusual terms either in a separate definition section or in the appropriate discussion section. Define any acronyms or abbreviations (which should be limited unless an acronym is commonly used).> Qualifications and Responsibilities <Identify any special qualifications users should have, such as certification or training experience, to complete the task satisfactorily. Denote any individual or positions having responsibility for the activity being described (accountability and responsibility must be included with every SOP).> Procedure(s) <Denote what sequential procedures should be followed, divided into significant sections. Use figures and cartoons where helpful. It is often helpful to include a process flow chart.>
Overview <Provide a brief overview about the SOP> Purpose <Describe the purpose of the work or process.> Scope <Outline the scope and limits of the SOP.> Guiding Principles <Reference any sources and legislation that are relevant to the procedure. In particular referencing the relevant International Conference on Harmonisation documentation on Good Clinical Practice and the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research is recommended. An example is provided below: > Research studies should be conducted in accordance with applicable legislation and regulatory standards. Thus, this document has been guided by the following resources: International Conference on Harmonisation documentation on Good Clinical Practice (ICH-GCP, ) and the Therapeutic Goods Administration (TGA) annotated version (). the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (henceforth referred to as the ‘national statement’, ), The Australian Code for the Responsible Conduct of Research (), Therapeutic Goods Administration’s Australian Clinical Trial Handbook (), and Declaration of Helsinki (). Definitions and Abbreviations <Define any specialized or unusual terms either in a separate definition section or in the appropriate discussion section. Define any acronyms or abbreviations (which should be limited unless an acronym is commonly used).> Qualifications and Responsibilities <Identify any special qualifications users should have, such as certification or training experience, to complete the task satisfactorily. Denote any individual or positions having responsibility for the activity being described (accountability and responsibility must be included with every SOP).> Procedure(s) <Denote what sequential procedures should be followed, divided into significant sections. Use figures and cartoons where helpful. It is often helpful to include a process flow chart.>