SM-303.01 - STANDARD OPERATING PROCEDURE - Documentation and Records Retention

Sep 19, 2026

Upload by Jake

STANDARD OPERATING PROCEDURE SM-303.01 defines how Georgia CORE creates, collects, reviews, files, and stores study-related documents and records to meet federal regulatory and clinical expectations. 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.

LanguageEnglish

CategoryGeneral

FormatPDF

Pages21

Reading Time7 min

AccessFree to download

Introduction and Purpose

Scope

Applicable Regulations and Guidelines

References to Other Applicable SOPs

Attachments

Responsibility

Definitions

Study Management SM – 303.01 STANDARD OPERATING PROCEDURE FOR Documentation and Records Retention Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature and Date) Approval: Frederick M. Schnell, MD, FACP Chief Medical Officer 30 May 2017 (Signature and Date) Issue Date: 01 June 2017 Effective Date: 01 June 2017 Expiration Date: 01 June 2019 Document Review Date: 01 March 2017 Reviewer: Joni N. Shortt, BSN, RN, CCRC Primary Author: Anita Clavier, BSN, MPH Previous Reviewer: Alice S. Kerber, MN, APRN (March 2014) I. INTRODUCTION AND PURPOSE Federal 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. 2. SCOPE This 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. 3. APPLICABLE REGULATIONS AND GUIDELINES 21 CFR 312.50 21 CFR 312.56 21 CFR 312.60 21 CFR 312.62 21 CFR 312.64 21 CFR 312.66 21 CFR 312.68 December 2008 March 2011 January 1988 May 9 1997 General responsibilities of sponsors Review of ongoing investigations General responsibilities of investigators Investigator recordkeeping and record retention Investigator reports Assurance of IRB review Inspection of investigator’s records and reports FDA Compliance Program Guidance Manual 7348.811: Clinical Investigators FDA Compliance Program Guidance Manual 7348.810: Sponsors, Contract Research Organizations and Monitors Guidelines for the Monitoring of Clinical Investigations International Conference on Harmonization; Good Clinical Practice: Consolidated Guideline 4. REFERENCES TO OTHER APPLICABLE SOPS GA-102 Sponsor Responsibility and Delegation of Responsibility SS-204 Site Initiation Visit (SIV) SM-304 Routine Monitoring Visits SM-305 Closeout Visits DM-401 Data Management QA-601 Audits by Third Parties 5. ATTACHMENTS A. Adapted Summary of International Conference on Harmonization (ICH) Essential Documents; Section 8 of ICH; Good Clinical Practice: Consolidated Guideline, May 9, 1997 B. Georgia CORE Regulatory Master File Structure 6. RESPONSIBILITY This SOP applies to those members of Georgia CORE involved in clinical trials. 􀁸 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. 􀁸 The Designee (monitor) is responsible for verifying that the files are complete, accurate and securely maintained by the Investigator and Subinvestigators. 􀁸 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. 7. DEFINITIONS The following definitions from the International Conference on Harmonization, Good Clinical Practice: Consolidated Guideline apply to this SOP. Case 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. Compliance (in relation to trials): Adherence to all the trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. Confidentiality: Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity. Contract: A written, dated, and signed agreement betw

FAQs

What is the purpose of SOP SM-303.01?

It describes steps Georgia CORE follows to create, collect, review, file, and store study-related documents and records to fulfill regulatory and clinical requirements.

What activities does this SOP cover under its scope?

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.

Who is responsible for ensuring documentation accuracy and completeness?

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.

Sep 19, 2026

Upload by Jake