Independent Site SOP Library
Reference Edition 1.3
The full 48-SOP text the Lean and Network editions were condensed from. Use it for regulatory background, longer explanations and source wording, not as the set a small site adopts.
Start here
What this is. A configurable template set of SOPs, forms and guides for US clinical research sites running FDA-regulated drug, biologic and device trials, written to the regulatory baseline of 23 October 2026 (see the Regulatory Currency Note). This Reference Edition is the full set (48 SOPs). A shorter Lean Edition for small single sites and a separate Network Edition are built from it.
Review status. Prepared as a template with automated and simulated review: a citation audit, two scenario walkthroughs and a structured adversarial expert review. As of 1 November 2026 it has not been reviewed by counsel or by a practicing site QA lead, and no site has yet adopted it. Open items for counsel: the network points on the Anti-Kickback Statute, Stark, DEA registration and HIPAA structures, and Network Office feasibility queries under a business associate agreement.
What it covers and excludes. Written for independent sites and site networks running industry-sponsored studies, with one supplemental SOP for investigator-initiated studies. Excluded topics are listed in Adoption Guide section 7 (for example Phase 1 units, oncology and radiation specifics, gene therapy and pharmacy compounding).
Who owns it once adopted. Once [SITE NAME] approves these documents they are the site's own SOPs; the site is responsible for every step it adopts and should remove or change any step it will not follow.
How to start
- Read the Adoption Guide sections 1 to 3 and decide your operating model (single site or network).
- Name a Quality Lead and an independent reviewer (SOP-102, 5.3).
- Work through the Site decision register and the [DEFAULT] values, and complete Appendix A for each state.
- Approve, train and set the effective date under SOP-100.
Standard operating procedures
Purpose is the first sentence of each SOP's section 1. Pages are estimated at 450 words per page.
SOPs (all sites) (42)
| Number | Title | Purpose | Approx. pages | Links |
|---|---|---|---|---|
| SOP-100 | Writing, Approving and Controlling SOPs | This SOP describes how [SITE NAME] writes, reviews, approves, issues, trains on, revises and retires its standard operating procedures (SOPs), study-specific work instructions and controlled forms. | 9 | Read online Word |
| SOP-101 | Roles and Responsibilities of the Principal Investigator | This SOP sets out the duties of the Principal Investigator (PI) at [SITE NAME] for FDA-regulated clinical investigations, how the PI documents acceptance of those duties, how the PI oversees the people and parties to whom tasks are delegated, and how investigator coverage is maintained when the PI is absent. | 10 | Read online Word |
| SOP-102 | Site Organization, Roles and Staff Responsibilities | This SOP describes how [SITE NAME] documents its organization and reporting lines, defines research roles, manages combined roles at a small site without losing needed independence, organizes work across multiple locations, and brings staff on and off the research team, including granting and removing system access. | 11 | Read online Word |
| SOP-103 | Staff Qualification, Training and Training Records | This SOP describes how [SITE NAME] confirms that each person working on clinical research is qualified by education, training and experience for their tasks, what training they complete and when, how competency is checked, and how qualification and training records are kept so they can be shown to sponsors, IRBs and inspectors. | 7 | Read online Word |
| SOP-104 | Conflict of Interest and Financial Disclosure | This SOP describes how investigators at [SITE NAME] provide accurate financial disclosure information to sponsors under 21 CFR 54 and keep it current, and how the site identifies, reviews, manages and discloses financial and other conflicts of interest of investigators, staff and the site itself. | 7 | Read online Word |
| SOP-105 | Oversight of Service Providers and Vendors | This SOP describes how [SITE NAME] selects, qualifies, contracts with and oversees service providers that perform trial-related activities on behalf of the investigator, and how the site handles service providers that the sponsor selects. | 9 | Read online Word |
| SOP-200 | Study Feasibility and Selection | This SOP describes how [SITE NAME] assesses whether it can conduct a proposed clinical trial, answers sponsor and CRO feasibility questionnaires with data it can support, and makes and records a go/no-go decision. | 7 | Read online Word |
| SOP-201 | Confidentiality Agreements, Clinical Trial Agreements and Budgets | This SOP describes how [SITE NAME] reviews, negotiates, approves and signs confidentiality agreements (CDAs) and clinical trial agreements (CTAs), builds and negotiates study budgets, and invoices and reconciles study payments. | 8 | Read online Word |
| SOP-202 | Medicare Coverage Analysis and Research Billing Compliance | This SOP describes how [SITE NAME] decides which items and services in a clinical study may be billed to Medicare or other insurers as routine care and which must be paid by the sponsor or not charged at all, and how the site keeps research claims accurate. | 8 | Read online Word |
| SOP-203 | IRB Submissions, Approval and Continuing Oversight | This SOP describes how [SITE NAME] obtains IRB approval before a study starts, keeps approval current without a lapse, submits changes and reports, uses only IRB-approved materials, and closes the study with the IRB. | 8 | Read online Word |
| SOP-204 | Essential Documents and the Investigator Site File | This SOP describes how [SITE NAME] sets up, maintains, controls and closes the Investigator Site File (ISF) for each study, on paper or electronically, so that the site's essential records show how the study was conducted and can be produced on request to a monitor, auditor, IRB or FDA inspector. | 7 | Read online Word |
| SOP-205 | Site Qualification, Initiation and Study Activation | This SOP describes how [SITE NAME] prepares for and hosts the sponsor's site qualification visit and site initiation visit (SIV), and how the site confirms that every regulatory, contractual, training, supply and system requirement is met before the first study procedure. | 7 | Read online Word |
| SOP-300 | Participant Recruitment, Pre-Screening and Advertising | This SOP describes how [SITE NAME] finds and approaches potential trial participants. | 10 | Read online Word |
| SOP-301 | Informed Consent Process and Documentation | This SOP describes how [SITE NAME] obtains, documents and maintains the informed consent of trial participants. | 14 | Read online Word |
| SOP-302 | Delegation of Authority | This SOP describes how the Principal Investigator (PI) at [SITE NAME] delegates trial-related activities to qualified staff and service providers, documents that delegation, keeps it current, and oversees the people performing delegated activities. | 7 | Read online Word |
| SOP-303 | Screening, Eligibility Verification and Enrollment | This SOP describes how [SITE NAME] screens consented participants, verifies and documents that each participant meets every eligibility criterion before randomization or first dose, registers participants in the sponsor's interactive response technology (IRT) system, and documents screen failures, rescreening and enrollment. | 7 | Read online Word |
| SOP-304 | Investigational Product Management | This SOP describes how [SITE NAME] receives, stores, secures, dispenses, accounts for, returns and destroys investigational product (IP), so that IP is used only as the protocol directs, its quality is maintained, and every unit can be traced from receipt to final disposition. | 10 | Read online Word |
| SOP-305 | Randomization, Blinding and Emergency Unblinding | This SOP describes how [SITE NAME] randomizes participants, keeps treatment assignments blinded, separates blinded and unblinded staff, breaks the blind in an emergency, and handles accidental unblinding. | 4 | Read online Word |
| SOP-306 | Source Documentation and Data Integrity (ALCOA+) | This SOP sets how [SITE NAME] defines, creates, corrects and protects source records so that trial data can be traced back to the participant and the person who recorded them, and can be reconstructed by a monitor, auditor or inspector. | 6 | Read online Word |
| SOP-307 | Case Report Forms, EDC Entry and Query Resolution | This SOP describes how [SITE NAME] enters trial data into case report forms (CRFs), most often in the sponsor's electronic data capture (EDC) system, responds to data queries, and gives investigator sign-off, so that reported data match source and are submitted on time. | 4 | Read online Word |
| SOP-308 | Protocol Deviations and Noncompliance | This SOP describes how [SITE NAME] prevents, identifies, documents, assesses, reports and learns from protocol deviations and other noncompliance, including changes made to eliminate an immediate hazard to participants. | 5 | Read online Word |
| SOP-309 | Participant Retention, Withdrawal and Lost to Follow-Up | This SOP describes how [SITE NAME] keeps participants engaged through the end of a study, handles a participant's decision to stop treatment or leave the study, withdraws participants when the investigator decides to, and documents attempts to reach participants who stop attending. | 5 | Read online Word |
| SOP-310 | Participant Payments and Reimbursement | This SOP describes how [SITE NAME] pays trial participants for their time and reimburses their trial-related expenses. | 8 | Read online Word |
| SOP-311 | Biological Specimen Collection, Processing and Shipping | This SOP describes how [SITE NAME] collects, labels, processes, stores and ships biological specimens for clinical trials so that each specimen reaches the laboratory identifiable, intact, within its stability window and with a documented chain of custody, and so that shipments meet US Department of Transportation (DOT) and International Air Transport Association (IATA) dangerous goods requirements. | 8 | Read online Word |
| SOP-312 | Equipment Calibration and Maintenance; Local Laboratory Requirements | This SOP describes how [SITE NAME] keeps equipment used for trial activities fit for purpose through inventory, calibration, preventive maintenance and handling of out-of-tolerance results, and how the site meets laboratory requirements for testing done on site (CLIA) and for local laboratories used in trials. | 7 | Read online Word |
| SOP-313 | Decentralized Trial Elements (Remote Visits, Home Health, Direct-to-Participant IP) | This SOP describes how [SITE NAME] conducts trial activities away from the site: telehealth visits, home health visits by site staff or vendors, procedures by local healthcare providers, direct-to-participant shipment of investigational product (IP), and digital health technologies (DHTs). | 8 | Read online Word |
| SOP-400 | Participant Privacy and HIPAA in Research | This SOP describes how [SITE NAME] protects the privacy and confidentiality of prospective and enrolled participants' information, how it applies the HIPAA Privacy, Security and Breach Notification Rules to research, and how it handles privacy incidents. | 11 | Read online Word |
| SOP-401 | Computerized Systems and Electronic Records | This SOP describes how [SITE NAME] selects, assesses, uses and controls computerized systems that create, modify, maintain, archive, retrieve or transmit trial records. | 9 | Read online Word |
| SOP-402 | Record Retention, Archiving and Destruction | This SOP describes how [SITE NAME] determines how long trial records must be kept, archives them so they stay complete, readable and retrievable, retrieves them when monitors, auditors or regulators ask, and destroys them securely when retention ends. | 7 | Read online Word |
| SOP-500 | Adverse Event Identification, Assessment and Recording | This SOP describes how [SITE NAME] identifies, assesses, documents and records adverse events (AEs) in clinical trials, and how investigators provide medical care for participants who experience them. | 7 | Read online Word |
| SOP-501 | Serious Adverse Event and Expedited Safety Reporting | This SOP describes how [SITE NAME] recognizes serious adverse events (SAEs), reports them to the sponsor within the required time, follows them to resolution, reports unanticipated adverse device effects (UADEs), and receives and processes safety information sent by sponsors (IND safety reports, SUSAR letters and device safety notices). | 8 | Read online Word |
| SOP-502 | Unanticipated Problems and Reportable New Information | This SOP describes how [SITE NAME] identifies, assesses and reports to the IRB unanticipated problems involving risks to participants or others, and other information the IRB requires investigators to report promptly (commonly called reportable new information). | 7 | Read online Word |
| SOP-503 | Pregnancy Reporting in Clinical Trials | This SOP describes how [SITE NAME] counsels participants on pregnancy prevention, performs pregnancy testing, manages a participant who becomes pregnant, reports pregnancies of participants and of participants' partners to the sponsor, and follows each pregnancy to outcome. | 4 | Read online Word |
| SOP-600 | Sponsor Monitoring Visits | This SOP describes how [SITE NAME] prepares for, hosts and follows up on sponsor monitoring, whether performed on site, remotely or centrally, and how monitoring findings are tracked to closure. | 5 | Read online Word |
| SOP-601 | Study Closeout | This SOP describes how [SITE NAME] closes a trial at the site, whether at planned completion or after early termination or suspension, so that participants are informed and cared for, data and records are complete, investigational product and specimens are reconciled, IRB and financial obligations are met, and records are archived. | 6 | Read online Word |
| SOP-700 | Internal Quality Control and Quality Assurance Audits | This SOP describes how [SITE NAME] checks its own work. | 9 | Read online Word |
| SOP-701 | Sponsor and IRB Audits | This SOP describes how [SITE NAME] prepares for, hosts and follows up on audits of its studies by sponsors, contract research organizations (CROs) acting for sponsors, independent auditors engaged by sponsors, and IRBs. | 6 | Read online Word |
| SOP-702 | FDA Inspections and Remote Regulatory Assessments | This SOP describes how [SITE NAME] stays ready for, hosts and responds to FDA Bioresearch Monitoring (BIMO) inspections of clinical investigators and FDA Remote Regulatory Assessments (RRAs). | 10 | Read online Word |
| SOP-703 | Corrective and Preventive Action (CAPA) | This SOP describes how [SITE NAME] identifies the cause of quality problems, plans and completes corrective and preventive actions, checks that the actions worked, and tracks CAPAs to closure. | 6 | Read online Word |
| SOP-704 | Research Misconduct and Fraud Reporting | This SOP describes how [SITE NAME] recognizes, reports, assesses and investigates possible research misconduct and fraud, protects people who report concerns, notifies sponsors, IRBs and FDA where required, and screens staff and service providers against federal debarment, disqualification and exclusion lists. | 8 | Read online Word |
| SOP-705 | Business Continuity and Emergency Preparedness | This SOP describes how [SITE NAME] plans for and responds to events that disrupt study conduct, so that participants stay safe, investigational product (IP) and specimens are protected, records and data are preserved, and studies continue or are transferred in an orderly way. | 9 | Read online Word |
| SOP-800 | Sponsor-Investigator Responsibilities (IND/IDE Holder) | This SOP describes the additional obligations that apply when an investigator at [SITE NAME] both initiates and conducts a clinical investigation as a sponsor-investigator, including the decision whether an IND or IDE is needed, the submission, the sponsor duties that follow, safety and progress reporting to FDA, and ClinicalTrials.gov registration and results reporting. | 10 | Read online Word |
Network SOPs (Model N only) (6)
| Number | Title | Purpose | Approx. pages | Links |
|---|---|---|---|---|
| SOP-900 | Network Governance, SOP Hierarchy and Local Addenda | This SOP sets up the governance of [NETWORK NAME] when this SOP library runs as a network. | 10 | Read online Word |
| SOP-901 | Member Site Onboarding, Integration and Exit | This SOP describes how [NETWORK NAME] assesses a research site that is joining the network, brings it onto the network SOPs, systems and agreements without interrupting participant care or open studies, and handles a member site that leaves the network or closes. | 10 | Read online Word |
| SOP-902 | Network Study Feasibility, Allocation and Central Contracting | This SOP describes how [NETWORK NAME] receives sponsor study inquiries centrally, combines member site feasibility into one honest network response, decides which member sites take a study, and negotiates master agreements, clinical trial agreements (CTAs), budgets and coverage analyses centrally. | 9 | Read online Word |
| SOP-903 | Network Oversight of Member Sites (Metrics, Central QA, Escalation) | This SOP describes how the Network Office of [NETWORK NAME] oversees the quality and performance of its member sites. | 9 | Read online Word |
| SOP-904 | Shared Staff, Cross-Site Coverage and Central Services | This SOP describes how [NETWORK NAME] deploys staff who work at more than one member site, provides central services to member sites, and covers key roles across sites when people are absent. | 10 | Read online Word |
| SOP-905 | Network Data, Systems, Privacy and Records Across Sites | This SOP describes how [NETWORK NAME] runs computerized systems shared by member sites, controls who can see each member site's records, applies HIPAA when information moves between the Network Office and member sites, keeps each investigator in control of their study records, and handles privacy incidents that involve more than one entity. | 11 | Read online Word |
Forms and logs (59)
Forms are Word files only. Each one names the SOP that uses it.
| Code | Title | Owning SOP | Download |
|---|---|---|---|
| F-100-01 | SOP Review and Approval Record | SOP-100 | Word |
| F-100-02 | SOP Training Acknowledgment | SOP-100 | Word |
| F-100-03 | SOP Master Index and Review Schedule | SOP-100 | Word |
| F-102-01 | Site Organization Chart and Role Assignment Record | SOP-102 | Word |
| F-102-02 | Staff Onboarding and Offboarding Checklist | SOP-102 | Word |
| F-103-01 | Staff Training Log | SOP-103 | Word |
| F-103-02 | Staff Qualification File Checklist | SOP-103 | Word |
| F-104-01 | Conflict of Interest and Financial Interest Disclosure | SOP-104 | Word |
| F-105-01 | Service Provider Qualification and Oversight Record | SOP-105 | Word |
| F-200-01 | Study Feasibility Assessment | SOP-200 | Word |
| F-201-01 | Contract and Budget Review Checklist | SOP-201 | Word |
| F-202-01 | Coverage Analysis Worksheet | SOP-202 | Word |
| F-204-01 | Investigator Site File Index | SOP-204 | Word |
| F-205-01 | Study Activation Checklist | SOP-205 | Word |
| F-300-01 | Pre-Screening Log | SOP-300 | Word |
| F-300-02 | Recruitment Material Tracking Log | SOP-300 | Word |
| F-301-01 | Informed Consent Process Note | SOP-301 | Word |
| F-301-02 | Consent Form Version Control Log | SOP-301 | Word |
| F-302-01 | Delegation of Authority Log | SOP-302 | Word |
| F-303-01 | Screening and Enrollment Log | SOP-303 | Word |
| F-303-02 | Eligibility Verification Checklist | SOP-303 | Word |
| F-304-01 | Investigational Product Accountability Log | SOP-304 | Word |
| F-304-04 | Participant IP Dispensing and Return Log | SOP-304 | Word |
| F-304-02 | Temperature Monitoring Log | SOP-304 | Word |
| F-304-03 | Temperature Excursion Report | SOP-304 | Word |
| F-305-01 | Emergency Unblinding Record | SOP-305 | Word |
| F-306-01 | Note to File | SOP-306 | Word |
| F-308-01 | Protocol Deviation Log | SOP-308 | Word |
| F-309-01 | Participant Contact and Retention Log | SOP-309 | Word |
| F-310-01 | Participant Payment Log | SOP-310 | Word |
| F-311-01 | Specimen Processing and Shipment Log | SOP-311 | Word |
| F-312-01 | Equipment Inventory and Calibration Log | SOP-312 | Word |
| F-313-01 | Remote Visit and Home Health Visit Record | SOP-313 | Word |
| F-400-01 | Privacy Incident Report | SOP-400 | Word |
| F-401-01 | Computerized System Inventory and Access Log | SOP-401 | Word |
| F-402-01 | Record Archiving and Retrieval Log | SOP-402 | Word |
| F-500-01 | Adverse Event Assessment Worksheet | SOP-500 | Word |
| F-501-01 | SAE Reporting Tracker | SOP-501 | Word |
| F-502-01 | Reportable New Information Assessment | SOP-502 | Word |
| F-503-01 | Pregnancy Report Tracker | SOP-503 | Word |
| F-600-01 | Monitoring Visit Log | SOP-600 | Word |
| F-600-02 | Monitoring Follow-Up Action Tracker | SOP-600 | Word |
| F-601-01 | Study Closeout Checklist | SOP-601 | Word |
| F-700-01 | Internal QC Review Checklist | SOP-700 | Word |
| F-700-02 | Annual Audit Plan and Audit Report | SOP-700 | Word |
| F-702-01 | Inspection Request and Document Log | SOP-702 | Word |
| F-703-01 | CAPA Record | SOP-703 | Word |
| F-703-02 | CAPA Log | SOP-703 | Word |
| F-704-01 | Integrity Concern Report | SOP-704 | Word |
| F-705-01 | Business Continuity Plan and Emergency Contacts | SOP-705 | Word |
| F-900-01 | Local Addendum to a Network SOP | SOP-900 | Word |
| F-900-02 | Network Operating Model and Appendix B Adoption Record | SOP-900 | Word |
| F-901-01 | Member Site Gap Assessment | SOP-901 | Word |
| F-901-02 | Member Site Integration Plan and Exit Checklist | SOP-901 | Word |
| F-902-01 | Study Allocation Decision Record | SOP-902 | Word |
| F-903-01 | Member Site Performance and Quality Scorecard | SOP-903 | Word |
| F-903-02 | Escalation and Site Support Plan | SOP-903 | Word |
| F-904-01 | Shared Staff Assignment and Credentialing Log | SOP-904 | Word |
| F-905-01 | Cross-Entity Data Flow Register | SOP-905 | Word |
Guides and appendices
How to choose modules, configure, approve, train on and put the library into use.
Worksheet the site completes for each state where it works: the state-law points the SOPs depend on.
Model N only: who does each activity, the Network Office or the member site.
The regulations and guidance the library was written against, and the items to re-check.
Independent Site SOP Library. Licensed CC BY-NC 4.0 by the American Institute for Medical Research (AIMR), with added permission for any site's internal use (license terms). Not legal advice: each adopting site confirms state law, IRB and sponsor requirements with its own counsel and owns every step it approves.