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The SOP covers regulatory record maintenance for clinical studies under IND rules for drugs and biologics, including IND-exempt studies across investigational phases. It specifies applicable CFR regulations, referenced guidance, supporting SOPs, attachment materials, roles and responsibilities, and key definitions such as CRFs, confidentiality, documentation, essential documents, good clinical practice, and direct access.",{"@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/sm-30301-standard-operating-procedure-documentation-and-records-retention/307332/",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/sm-30301-standard-operating-procedure-documentation-and-records-retention/307332.png","ImageObject",442,249,{"name":88,"@type":89},"Jake","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-09-21","2026-09-19",true,{"@type":98,"interactionType":99,"userInteractionCount":73},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the purpose of SOP SM-303.01?","Question",{"text":108,"@type":109},"It describes steps Georgia CORE follows to create, collect, review, file, and store study-related documents and records to fulfill regulatory and clinical requirements.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What activities does this SOP cover under its scope?",{"text":113,"@type":109},"It covers establishing and maintaining regulatory records for clinical studies subject to IND regulations for drugs and biologics, including IND-exempt studies during investigational development phases.",{"name":115,"@type":106,"acceptedAnswer":116},"Who is responsible for ensuring documentation accuracy and completeness?",{"text":117,"@type":109},"Georgia CORE, its network investigators, and subinvestigators must collect, document, and maintain complete and precise data; the Designee (monitor) verifies files are complete, accurate, and securely maintained.","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},307332,1789848033,{"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":73,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":45,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":125,"read_time":139},962084928904,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","Study Management  \nSM – 303.01  \nSTANDARD OPERATING PROCEDURE FOR Documentation and Records Retention  \nApproval: Nancy Paris, MS, FACHE  \nPresident and CEO  \n24 May 2017  \n(Signature and Date)  \nApproval: Frederick M. Schnell, MD, FACP  \nChief Medical Officer  \n30 May 2017  \n(Signature and Date)  \nIssue Date: 01 June 2017  \nEffective Date: 01 June 2017  \nExpiration Date: 01 June 2019  \nDocument Review Date: 01 March 2017  \nReviewer: Joni N. Shortt, BSN, RN, CCRC  \nPrimary Author: Anita Clavier, BSN, MPH  \nPrevious Reviewer: Alice S. Kerber, MN, APRN (March 2014)  \nI. INTRODUCTION AND PURPOSE  \nFederal regulations require documentation of all study-related activities. This standard operating procedure (SOP) describes the steps Georgia CORE follows to fulfill all regulatory and clinical requirements for creating, collecting, reviewing, filing and storing study-related documents and records.  \n2. SCOPE  \nThis SOP applies to the activities involved in establishing and maintaining the regulatory records for all clinical studies subject to investigational new drug (IND) regulations for drugs and biologics and those which are IND exempt during all investigational phases of development.  \n3. APPLICABLE REGULATIONS AND GUIDELINES  \n21 CFR 312.50  \n21 CFR 312.56  \n21 CFR 312.60  \n21 CFR 312.62  \n21 CFR 312.64  \n21 CFR 312.66  \n21 CFR 312.68 December 2008  \nMarch 2011  \nJanuary 1988 May 9 1997  \nGeneral responsibilities of sponsors Review of ongoing investigations  \nGeneral responsibilities of investigators Investigator recordkeeping and record retention Investigator reports  \nAssurance of IRB review  \nInspection of investigator’s records and reports  \nFDA Compliance Program Guidance Manual 7348.811: Clinical Investigators  \nFDA Compliance Program Guidance Manual 7348.810: Sponsors, Contract Research Organizations and Monitors  \nGuidelines for the Monitoring of Clinical Investigations International Conference on Harmonization; Good Clinical Practice:  \nConsolidated Guideline  \n4. REFERENCES TO OTHER APPLICABLE SOPS  \nGA-102 Sponsor Responsibility and Delegation of Responsibility  \nSS-204 Site Initiation Visit (SIV)  \nSM-304 Routine Monitoring Visits  \nSM-305 Closeout Visits  \nDM-401 Data Management  \nQA-601 Audits by Third Parties  \n5. ATTACHMENTS  \nA. Adapted Summary of International Conference on Harmonization (ICH) Essential Documents; Section 8 of ICH; Good Clinical Practice: Consolidated Guideline, May 9, 1997  \nB. Georgia CORE Regulatory Master File Structure  \n6. RESPONSIBILITY  \nThis SOP applies to those members of Georgia CORE involved in clinical trials.  \n􀁸 Georgia CORE and all Georgia CORE network Investigators and Subinvestigators are responsible for ensuring that complete and precise data are collected, documented, and maintained throughout the course of a clinical study involving human subjects.  \n􀁸 The Designee (monitor) is responsible for verifying that the files are complete, accurate and securely maintained by the Investigator and Subinvestigators.  \n􀁸 Georgia CORE is responsible for terminating the participation of and discontinuing shipments of investigational product to any participating Investigator or Subinvestigator who has failed to maintain or make available required records or reports of the study.  \n7. DEFINITIONS  \nThe following definitions from the International Conference on Harmonization, Good Clinical Practice: Consolidated Guideline apply to this SOP.  \nCase Report Form (CRF): A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject.  \nCompliance (in relation to trials): Adherence to all the trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements.  \nConfidentiality: Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.  \nContract: A written, dated, and signed agreement betw","cbCaieMgtJ66KHdQ","https://ap.wps.com/l/cbCaieMgtJ66KHdQ","pdf",615791,"English","# Introduction and Purpose\n# Scope\n# Applicable Regulations and Guidelines\n# References to Other Applicable SOPs\n# Attachments\n# Responsibility\n# Definitions","[{\"question\":\"What is the purpose of SOP SM-303.01?\",\"answer\":\"It describes steps Georgia CORE follows to create, collect, review, file, and store study-related documents and records to fulfill regulatory and clinical requirements.\"},{\"question\":\"What activities does this SOP cover under its scope?\",\"answer\":\"It covers establishing and maintaining regulatory records for clinical studies subject to IND regulations for drugs and biologics, including IND-exempt studies during investigational development phases.\"},{\"question\":\"Who is responsible for ensuring documentation accuracy and completeness?\",\"answer\":\"Georgia CORE, its network investigators, and subinvestigators must collect, document, and maintain complete and precise data; the Designee (monitor) verifies files are complete, accurate, and securely maintained.\"}]","SM-303.01 - STANDARD OPERATING PROCEDURE - Documentation and Records Retention | PDF",7]