[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-174304-en":3,"doc-seo-174304-105":31,"detail-sidebar-cat-1-en-105":92},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":11,"category_id":12,"category_name":13,"doc_title":14,"doc_description":15,"doc_content":16,"file_id":17,"file_url":18,"file_type":19,"file_size":20,"view_count":21,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":22,"language":23,"language_code":24,"site_id":25,"html_lang":24,"table_of_contents":26,"faqs":27,"seo_title":28,"seo_description":15,"update_tm":29,"read_time":30},174304,8796095462418,"Noah","https://ap-avatar.wpscdn.com/avatar/80000253c1241d02b47?x-image-process=image/resize,m_fixed,w_180,h_180&k=1778826106357471780",1,11,"Presentations","N2 Quality Committee Guidance for Developing Monitoring Plans","Guidance document for study sponsors on creating a monitoring plan for clinical trials, aligned with ICH GCP E6 (R2). It describes sponsor responsibilities for ongoing quality control and site monitoring, including monitor training, qualifications, and familiarity with protocol, informed consent, SOPs, GCP, and regulations. It outlines options for on-site, centralized, and combined monitoring, rationale documentation, and responsibilities across involved parties, including oversight when delegating monitoring to a CRO.","N2 Quality Committee Guidance for Developing Monitoring Plans\n\u000f\nINTRODUCTION\nThe Sponsor/Sponsor-Investigator should implement a system to manage quality throughout all stages of the trial.   Ongoing quality control monitoring is one activity of a study’s overall quality management system.  Study monitoring is a Sponsor responsibility as outlined in ICH GCP E6 (R2). How and when monitoring will be done should be documented in a monitoring plan prior to activation of the study.\nThis guidance document is intended to assist a study sponsor in developing and creating a monitoring plan for a clinical trial. Each section of a monitoring plan is outlined below and a description of the type of language (as well as some template language) that could be included in each section is provided. Sites should also review the references listed below for additional information on developing monitoring plans.\nIt is the Sponsor/Sponsor-Investigator’s responsibility to ensure that all participating sites have adequate site monitoring conducted by qualified monitors appointed by the Sponsor. As per ICH GCP E6 (R2) Section 5.18.2 monitors should be appropriately trained, and have the scientific and/or clinical knowledge needed to monitor the trial adequately. Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and the applicable regulatory requirement(s). A monitor’s qualifications should be documented.  Monitors may be Investigators or site staff, but should not be directly involved in the conduct of the trial i.e., data collection, consenting participants.\nIn order to facilitate multi-site monitoring, alternatives to on-site monitoring include the delegation of monitoring activities to a Contract Research Organization (CRO). The Sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the Sponsor’s contracted CRO(s).\nThe Sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring. The Sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan) and the monitoring responsibilities of all the parties involved should be clearly documented.\nGlossary of terms\nMonitoring (As per Section 1.38 of ICH GCP E6 (R2)\nMonitoring is the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).\nMonitoring Plan (As per Section 1.38.1 of ICH GCP E6 (R2)\nA monitoring plan is a description of the methods, responsibilities and requirements for monitoring the trial, which also includes the rationale for the chosen monitoring strategy.\nThe Sponsor should develop a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial. The plan should describe the monitoring strategy, the monitoring responsibilities of each party involved, the various monitoring methods to be used and the rationale for their use. The plan should also emphasize the monitoring of critical data and processes. Particular attention should be given to those aspects that are not routine clinical practice and that require additional training. The monitoring plan should reference the applicable policies and procedures.\nOn-site Monitoring (As per ICH GCP E6 (R2) Section 5.18.3)\nOn-site monitoring is performed at the site(s) where the clinical trial is being conducted.\nCentralized Monitoring (As per ICH GCP E6 (R2) Section 5.18)\nCentralized monitoring is a remote evaluation of accumulating data, performed in a timely manner, supported by appropriately qualified ","cbCaingDmw4bFsRM","https://ap.wps.com/l/cbCaingDmw4bFsRM","docx",72250,2,17,"English","en",105,"# Introduction\n## Monitoring Plan Development\n## Sponsor Responsibilities and Monitor Qualifications\n## Monitoring Options and Oversight\n# Glossary of Terms\n## Monitoring and Monitoring Plan\n## On-site Monitoring and Centralized Monitoring\n## Key Roles (Sponsor, Sponsor-Investigator, QI, Investigator)","[{\"question\":\"Who is responsible for study monitoring in a clinical trial?\",\"answer\":\"Monitoring is a Sponsor responsibility as outlined in ICH GCP E6 (R2). The Sponsor must ensure that participating sites receive adequate monitoring by qualified monitors appointed by the Sponsor.\"},{\"question\":\"What qualifications and training should monitors have?\",\"answer\":\"Monitors should be appropriately trained and have sufficient scientific and/or clinical knowledge to monitor the trial effectively. They should be thoroughly familiar with the investigational products, protocol, informed consent documents, sponsor SOPs, GCP, and applicable regulatory requirements, and their qualifications should be documented.\"},{\"question\":\"What monitoring strategies can a sponsor choose?\",\"answer\":\"A sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring. The sponsor should document the rationale for the chosen strategy and clearly document monitoring responsibilities for all parties.\"}]","N2 Quality Committee Guidance for Developing Monitoring Plans | DOCX",1788311811,6,{"code":4,"msg":32,"data":33},"ok",{"site_id":25,"language":24,"slug":34,"title":14,"keywords":35,"description":15,"schema_data":36,"social_meta":87,"head_meta":89,"extra_data":91,"updated_unix":29},"n2-quality-committee-guidance-for-developing-monitoring-plans","",{"@graph":37,"@context":86},[38,54,69],{"@type":39,"itemListElement":40},"BreadcrumbList",[41,45,48,51],{"item":42,"name":43,"@type":44,"position":11},"https://docshare.wps.com","Home","ListItem",{"item":46,"name":47,"@type":44,"position":21},"https://docshare.wps.com/template/","Template",{"item":49,"name":13,"@type":44,"position":50},"https://docshare.wps.com/template/presentations/",3,{"item":52,"name":14,"@type":44,"position":53},"https://docshare.wps.com/template/n2-quality-committee-guidance-for-developing-monitoring-plans/174304/",4,{"url":52,"name":14,"@type":55,"author":56,"headline":14,"publisher":58,"fileFormat":61,"inLanguage":24,"description":15,"dateModified":62,"datePublished":63,"encodingFormat":61,"isAccessibleForFree":64,"interactionStatistic":65},"DigitalDocument",{"name":9,"@type":57},"Person",{"url":42,"name":59,"@type":60},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-03","2026-09-02",true,{"@type":66,"interactionType":67,"userInteractionCount":21},"InteractionCounter",{"@type":68},"ViewAction",{"@type":70,"mainEntity":71},"FAQPage",[72,78,82],{"name":73,"@type":74,"acceptedAnswer":75},"Who is responsible for study monitoring in a clinical trial?","Question",{"text":76,"@type":77},"Monitoring is a Sponsor responsibility as outlined in ICH GCP E6 (R2). The Sponsor must ensure that participating sites receive adequate monitoring by qualified monitors appointed by the Sponsor.","Answer",{"name":79,"@type":74,"acceptedAnswer":80},"What qualifications and training should monitors have?",{"text":81,"@type":77},"Monitors should be appropriately trained and have sufficient scientific and/or clinical knowledge to monitor the trial effectively. They should be thoroughly familiar with the investigational products, protocol, informed consent documents, sponsor SOPs, GCP, and applicable regulatory requirements, and their qualifications should be documented.",{"name":83,"@type":74,"acceptedAnswer":84},"What monitoring strategies can a sponsor choose?",{"text":85,"@type":77},"A sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring. 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