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It establishes expectations that all study personnel understand their delegated responsibilities, authority limits, and ICH GCP-related obligations to protect participants’ rights, safety, and well-being. It also sets requirements for recording delegations in the Staff Signature and Delegation Log, completing required training before listing staff, and maintaining supervision and documentation at the site.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":51,"@type":70,"position":76},"https://docshare.wps.com/template/general/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/424-delegation-of-duties-version-v12/243292/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/424-delegation-of-duties-version-v12/243292.png","ImageObject",442,249,{"name":88,"@type":89},"Aurora","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-09-19","2026-09-12",true,{"@type":98,"interactionType":99,"userInteractionCount":76},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What responsibility cannot be delegated in the delegation of trial duties?","Question",{"text":108,"@type":109},"Responsibility for the clinical trial cannot be delegated; only individual tasks/duties may be delegated to appropriately trained personnel.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"Which tasks and duties must be recorded, and where?",{"text":113,"@type":109},"Individual study related tasks/duties are defined and allocated prior to study initiation and recorded on the Staff Signature and Delegation Log held in the Investigator Site File.",{"name":115,"@type":106,"acceptedAnswer":116},"What requirements must be met before adding staff to the delegation log?",{"text":117,"@type":109},"All required protocol and other relevant training, including Good Clinical Practice training, must be completed before adding the staff member, and the start date must be on or after the training completion date.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},243292,1789202280,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":50,"category_name":51,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":76,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":125,"read_time":76},4810365810221,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","Standard Operating Procedure  \n4.2.4 Delegation of Duties  \n\n| Version | V1.2 |\n| --- | --- |\n| Author/s | C Strauss |\n| Approved | M Agar |\n| Effective date | 01/04/2022 |\n| Review date | 01/04/2024 |\n\nDO NOT USE THIS SOP IN PRINTED FORM WITHOUT FIRST CHECKING IT IS THE [LATEST VERSION AS AVAILABLE FROM](LATEST VERSION AS AVAILABLE FROM www.uts.edu.au/itcc)[ ](LATEST VERSION AS AVAILABLE FROM www.uts.edu.au/itcc)[www.uts.edu.au/itcc](LATEST VERSION AS AVAILABLE FROM www.uts.edu.au/itcc)  \nIntroduction / Background  \nIt is a requirement of Good Clinical Practice that personnel employed to work on clinical research studies are qualified to do so by education, training, and experience.  \nWhile maintaining responsibility for the conduct of the clinical trial, the Principal Investigator may delegate significant clinical study related tasks and duties to appropriately qualified and trained staff.  \nIt is the responsibility of the Principal Investigator to ensure that all study staff at the site understand and undertake their delegated tasks/duties in accordance with the study protocol and regulatory requirements to ensure the protection of the rights, safety, and well-being of participants.  \nThe Principal Investigator is responsible for supervising any individual or party to whom they have delegated tasks/duties at the trial site. This responsibility also extends to any external individual or party whose services are contracted and retained by the Principal Investigator/Institution to perform trial related duties and functions.  \nFor a clinical study to be conducted appropriately, it is essential that all involved personnel are aware of the anticipated extent of their involvement, their responsibilities relating to the International Conference on Harmonisation of Good Clinical Practice (ICH GCP) and the limits to their authority.  \nObjective  \nThis SOP describes the process of delegating tasks and duties related to the clinical trial.  \nScope  \nThis SOP applies to all staff directly involved in the conduct of the study including (but not limited to):  \n▪ Sub-Investigators/Co-Investigators  \n▪ Research Nurses  \n▪ Study Co-ordinators  \n▪ Clinical Trial Assistants  \n▪ Clinical Trial Pharmacists  \nThis SOP also applies to staff associated with, but not directly involved in the research including (but not limited to):  \n▪ Clinicians  \n▪ Specialist nurses  \n▪ Laboratory staff  \n▪ Radiologists  \n▪ Support staff  \nSome research will involve participants who are inpatients at the time, and where the nursing staff on the ward are required to collect data for the safety or primary outcome of the study. It  \nis not feasible to require each rostered nurse to be delegated tasks on the Staff Signature and Delegation Log (Template 1) , taking into account roster and rotation. It is acceptable to consider ward nursing staff in the description above, and to require the unit nurse manager (or equivalent) to sign the Staff Signature and Delegation Log. It is appropriate to complete a Staff Training Log (Template 3) for all staff within the inpatient unit to demonstrate that while individual ward nursing staff are not listed on the Staff Signature and Delegation Log, the staff are appropriately trained to complete their study related duties according to the protocol.  \nOwnership and Responsibility  \nThe Principal Investigator is responsible for delegating significant trial-related tasks/duties and for supervising any individual or party to whom they have delegated activities. Delegation of tasks/duties will be dependent on the qualifications and experience of team members.  \nProcedure  \nIndividual study related tasks and duties are defined, established, and allocated prior to the initiation of a study as per the Staff Signature and Delegation Log.  \nThe Principal Investigator may delegate key tasks and duties to other individuals based on their skill level, qualifications and the tasks required. These delegations are recorded on the Staff Signature an","cbCaikxp93Ef1ibs","https://ap.wps.com/l/cbCaikxp93Ef1ibs","pdf",205929,7,"English","# 4.2.4 Delegation of Duties\n## Introduction / Background\n## Objective\n## Scope\n## Ownership and Responsibility\n## Procedure","[{\"question\":\"What responsibility cannot be delegated in the delegation of trial duties?\",\"answer\":\"Responsibility for the clinical trial cannot be delegated; only individual tasks/duties may be delegated to appropriately trained personnel.\"},{\"question\":\"Which tasks and duties must be recorded, and where?\",\"answer\":\"Individual study related tasks/duties are defined and allocated prior to study initiation and recorded on the Staff Signature and Delegation Log held in the Investigator Site File.\"},{\"question\":\"What requirements must be met before adding staff to the delegation log?\",\"answer\":\"All required protocol and other relevant training, including Good Clinical Practice training, must be completed before adding the staff member, and the start date must be on or after the training completion date.\"}]","4.2.4 Delegation of Duties - Version V1.2 | PDF"]