Independent Site SOP Library
Lean Edition 2.0
Start here. 16 core SOPs every site adopts and 6 optional modules it adopts only when it does the activity, with the forms and guides they use. Written for a small single site.
Start here
What this is. A configurable template set of 16 core SOPs, 6 optional modules, forms and guides for a small independent US clinical research site running FDA-regulated drug, biologic and device trials, written to the regulatory baseline of 23 October 2026 (see the Regulatory Currency Note). It is condensed from the full Reference Edition (48 SOPs), which stays available for background and wording. Most independent sites also adopt SOP-M1 (any site using an outside laboratory, courier or IT or eReg vendor) and SOP-M2 (any site negotiating its own contracts), so a typical site adopts 18 to 19 SOPs (16 core plus its modules). Networks add the separate Network Edition.
Review status. The Lean Edition was condensed on 1 November 2026 from the Reference Edition, which had a citation audit, scenario walkthroughs and a structured adversarial expert review. The Lean text itself has had one structured adversarial expert review and the fixes it called for. As of 1 November 2026 it has not been reviewed by counsel or by a practicing site QA lead, and no site has adopted it. These statements describe the published template, not a site's adopted copy.
Publisher and updates. Published by the American Institute for Medical Research (AIMR). Updates and feedback: aimronline.org/sops. Release notes for each new release are posted there; a new release does not change a site's adopted SOPs until the site revises them under SOP-01.
License. Licensed under CC BY-NC 4.0 with an added permission: any research site, network or institution, including for-profit organizations, may copy, adapt and use these templates as its own internal procedures to run its own research operations. Selling, licensing or repackaging the templates, or delivering them as a paid consulting deliverable, requires written permission from AIMR. Attribution: 'Adapted from the Independent Site SOP Library by the American Institute for Medical Research (AIMR), aimronline.org/sops, CC BY-NC 4.0' (may be kept in the site's SOP master index).
What it covers and excludes. Written for industry-sponsored studies at a single site. Optional modules cover vendors, feasibility and contracting, recruitment, decentralized elements, research integrity reporting and sponsor-investigator studies. Excluded: Phase 1 units, oncology and radiation specifics, gene therapy and IBC, pharmacy compounding, and non-US trials.
Who owns it once adopted. Once [SITE NAME] approves these documents they are the site's own SOPs. Every step is a commitment an auditor can test, so change or remove any step the site will not follow before approval.
How to start
- Read this page and the Adoption Guide (about 1 hour).
- Name the Quality Lead and an independent reviewer who does not report to the Site Director (SOP-02). The reviewer is usually an outside person; the Adoption Guide, Step 1, lists who qualifies and the expected hours.
- Decide which optional modules apply, work through the Site decision register and the [DEFAULT] values, and complete Appendix A for your state.
- Approve under SOP-01, train each role on the SOPs marked Read and train below, then set the effective date.
Standard operating procedures
Purpose is the first sentence of each SOP's section 1. Pages are estimated at 450 words per page.
Core SOPs (all sites) (16)
| Number | Title | Purpose | Approx. pages | Links |
|---|---|---|---|---|
| SOP-01 | SOP Control, Training and Qualification | This SOP describes how [SITE NAME] writes, approves, issues, reviews and retires its SOPs, work instructions and controlled forms, and how it confirms that each person working on research is qualified and trained for their tasks and keeps the records that show it. | 7 | Read online Word |
| SOP-02 | Roles, PI Oversight, Delegation and Conflicts of Interest | This SOP describes how [SITE NAME] records its organization and roles, keeps needed independence when one person holds several roles, brings staff on and off the research team, how the Principal Investigator (PI) accepts a study, delegates and oversees trial-related activities, and how investigators and staff disclose and manage financial and other conflicts of interest. | 7 | Read online Word |
| SOP-03 | IRB Oversight, Essential Records and Study Activation | This SOP describes how [SITE NAME] obtains and keeps IRB approval, uses only IRB-approved materials, sets up and maintains the Investigator Site File (ISF), and confirms through the Study Activation Checklist (F-205-01) that every start-up requirement is met before the first study procedure. | 7 | Read online Word |
| SOP-04 | Informed Consent | This SOP describes how [SITE NAME] obtains, documents and maintains the informed consent of trial participants. | 9 | Read online Word |
| SOP-05 | Pre-Screening, Screening, Eligibility, Randomization and Blinding | This SOP describes how [SITE NAME] pre-screens candidates before consent, screens consented participants, verifies and documents eligibility before randomization or first dose, registers and randomizes participants in the sponsor's interactive response technology (IRT), keeps the blind, and handles emergency and accidental unblinding. | 7 | Read online Word |
| SOP-06 | Investigational Product Management | This SOP describes how [SITE NAME] receives, stores, monitors, secures, dispenses, accounts for, returns and destroys investigational product (IP), so that IP is used only as the protocol directs, its quality is kept, and every unit can be traced from receipt to final disposition. | 7 | Read online Word |
| SOP-07 | Source Documentation and EDC | This SOP describes how [SITE NAME] defines, records, corrects and protects source records, enters data into case report forms (CRFs), most often in the sponsor's electronic data capture (EDC) system, and resolves queries, so that every reported value can be traced to source and to the person who recorded it. | 6 | Read online Word |
| SOP-08 | Protocol Deviations and CAPA | This SOP describes how [SITE NAME] prevents, records, assesses and reports protocol deviations and other noncompliance, including changes made to eliminate an immediate hazard, and how it finds the cause of quality problems, takes corrective and preventive action (CAPA), checks that the action worked and closes it. | 7 | Read online Word |
| SOP-09 | Safety Reporting (AEs, SAEs, IRB-Reportable Events, Pregnancy) | [SITE NAME] uses this SOP to identify, assess and record adverse events (AEs), report serious adverse events (SAEs) and device events to the sponsor, process sponsor safety reports, report unanticipated problems and other reportable new information to the IRB, and manage and report pregnancies. | 9 | Read online Word |
| SOP-10 | Participant Retention, Withdrawal and Payments | [SITE NAME] uses this SOP to keep enrolled participants engaged to the end of a study, handle discontinuation and withdrawal, document attempts to reach participants who stop attending, and pay and reimburse participants as the IRB approved, with records a monitor, auditor or tax authority can follow. | 6 | Read online Word |
| SOP-11 | Specimens, Equipment and Laboratories | [SITE NAME] uses this SOP to collect, label, process, store and ship biological specimens so each reaches the laboratory identifiable, intact and within its stability window under DOT and IATA rules; to keep trial equipment calibrated and fit for use; and to meet CLIA requirements for on-site testing and document the laboratories used in each trial. | 7 | Read online Word |
| SOP-12 | Privacy, Electronic Systems and Record Retention | [SITE NAME] uses this SOP to protect participants' identifiable information under HIPAA and site policy, handle privacy incidents, control the computerized systems that hold trial records, and retain, archive, retrieve and destroy trial records for the required period. | 7 | Read online Word |
| SOP-13 | Monitoring, Audits and Inspections | This SOP describes how [SITE NAME] hosts and follows up on sponsor monitoring, sponsor and IRB audits, FDA inspections and FDA Remote Regulatory Assessments (RRAs), and tracks every finding to closure. | 7 | Read online Word |
| SOP-14 | Quality Control and Quality Review | This SOP describes how [SITE NAME] checks its own work: the site's single quality calendar, the study QC plan and consent QC sampling, the quarterly quality review, the annual internal audit and the annual management review. | 12 | Read online Word |
| SOP-15 | Study Closeout | This SOP describes how [SITE NAME] closes a trial, at planned completion or after early termination or suspension, so that participants are informed and cared for, data and records are complete, IP and specimens are reconciled, IRB and financial obligations are met and records are archived. | 5 | Read online Word |
| SOP-16 | Business Continuity and PI Coverage | This SOP describes how [SITE NAME] keeps participants safe and protects investigational product (IP), specimens and records when study conduct is disrupted, and how investigator coverage, PI departure and site closure or sale are handled. | 7 | Read online Word |
Modules (adopt when the site does the activity; most sites adopt SOP-M1 and SOP-M2) (6)
| Number | Title | Purpose | Approx. pages | Links |
|---|---|---|---|---|
| SOP-M1 | Service Providers and Vendors | This module describes how [SITE NAME] qualifies, contracts with and oversees service providers that perform trial-related activities for the investigator, and how it handles providers the sponsor selects. | 6 | Read online Word |
| SOP-M2 | Feasibility, Contracts, Budgets and Research Billing | This module describes how [SITE NAME] assesses and accepts studies, reviews and signs confidentiality agreements (CDAs) and clinical trial agreements (CTAs), builds budgets, invoices and reconciles study payments, and keeps research billing to insurers accurate. | 8 | Read online Word |
| SOP-M3 | Recruitment and Advertising | This module describes how [SITE NAME] plans recruitment, gets IRB approval for every participant-facing recruitment material, runs advertising, outreach, a research volunteer database and recruitment vendors, avoids undue influence, and reviews recruitment results. | 4 | Read online Word |
| SOP-M4 | Decentralized Trial Elements | This module describes how [SITE NAME] conducts trial activities away from the site: telehealth visits, home visits by site staff or vendors, procedures by local healthcare providers and direct-to-participant shipment of investigational product (IP). | 5 | Read online Word |
| SOP-M5 | Research Integrity and Misconduct Reporting | This module describes how [SITE NAME] receives, assesses and investigates possible research misconduct and fraud, protects people who report concerns, and notifies sponsors, IRBs and FDA. | 4 | Read online Word |
| SOP-M6 | Sponsor-Investigator Studies (IND/IDE Holder) | This module describes the gate [SITE NAME] applies before an investigator takes on the sponsor role for a clinical investigation, the sponsor quality system that must exist before enrollment, and the sponsor steps that follow: the IND or IDE decision and submission, sponsor oversight, safety and progress reporting to FDA, and ClinicalTrials.gov registration and results. | 6 | Read online Word |
Who reads what
"Read and train" means the role is trained on the SOP before the effective date. "Know where it is" means the role knows the SOP exists and where to find it. A blank cell means no training is needed.
| Role | PI / Sub-I | Site Director | Quality Lead | Reg. Coord. | CRC | IP Manager | Finance / Contracts |
|---|---|---|---|---|---|---|---|
| SOP-01 SOP control, training | Know where it is | Read and train | Read and train | Know where it is | Know where it is | Know where it is | Know where it is |
| SOP-02 Roles, oversight, delegation, COI | Read and train | Read and train | Read and train | Read and train | Read and train | Read and train | Read and train |
| SOP-03 IRB, essential records, activation | Read and train | Read and train | Read and train | Read and train | Know where it is | Know where it is | Know where it is |
| SOP-04 Informed consent | Read and train | Know where it is | Read and train | Read and train | Read and train | ||
| SOP-05 Screening, eligibility, blinding | Read and train | Read and train | Know where it is | Read and train | Read and train | ||
| SOP-06 Investigational product | Read and train | Read and train | Know where it is | Know where it is | Read and train | ||
| SOP-07 Source and EDC | Read and train | Read and train | Know where it is | Read and train | Know where it is | ||
| SOP-08 Deviations and CAPA | Read and train | Read and train | Read and train | Read and train | Read and train | Read and train | |
| SOP-09 Safety reporting | Read and train | Read and train | Read and train | Read and train | Know where it is | ||
| SOP-10 Retention, withdrawal, payments | Know where it is | Know where it is | Read and train | Read and train | Read and train | ||
| SOP-11 Specimens, equipment, labs | Know where it is | Read and train | Read and train | Read and train | |||
| SOP-12 Privacy, systems, records | Read and train | Read and train | Read and train | Read and train | Read and train | Read and train | Read and train |
| SOP-13 Monitoring, audits, inspections | Read and train | Read and train | Read and train | Read and train | Read and train | Read and train | |
| SOP-14 Quality control and review | Know where it is | Read and train | Read and train | Know where it is | Know where it is | Know where it is | |
| SOP-15 Closeout | Know where it is | Know where it is | Read and train | Read and train | Read and train | Read and train | Read and train |
| SOP-16 Continuity and PI coverage | Read and train | Read and train | Read and train | Know where it is | Know where it is | Read and train | |
| SOP-M1 Service providers (if adopted) | Read and train | Read and train | Read and train | Know where it is | Know where it is | Know where it is | Read and train |
| SOP-M2 Feasibility, contracts, billing (if adopted) | Know where it is | Read and train | Know where it is | Read and train | Read and train | Read and train | |
| SOP-M3 Recruitment, advertising (if adopted) | Know where it is | Know where it is | Know where it is | Know where it is | Read and train | ||
| SOP-M4 Decentralized elements (if adopted) | Read and train | Know where it is | Know where it is | Know where it is | Read and train | Read and train | |
| SOP-M5 Research integrity reporting (if adopted) | Know where it is | Read and train | Read and train | Know where it is | Know where it is | Know where it is | Know where it is |
| SOP-M6 Sponsor-investigator studies (if adopted) | Read and train | Read and train | Read and train | Read and train | Know where it is | Know where it is | Know where it is |
Forms and logs (50)
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-01 | Word |
| F-100-02 | SOP Training Acknowledgment | SOP-01 | Word |
| F-100-03 | SOP Master Index and Review Schedule | SOP-01 | Word |
| F-102-01 | Site Organization Chart and Role Assignment Record | SOP-02 | Word |
| F-102-02 | Staff Onboarding and Offboarding Checklist | SOP-02 | Word |
| F-103-01 | Staff Training Log | SOP-01 | Word |
| F-103-02 | Staff Qualification File Checklist | SOP-01 | Word |
| F-104-01 | Conflict of Interest and Financial Interest Disclosure | SOP-02 | Word |
| F-204-01 | Investigator Site File Index | SOP-03 | Word |
| F-205-01 | Study Activation Checklist | SOP-03 | Word |
| F-300-01 | Pre-Screening Log | SOP-05 | Word |
| F-301-01 | Informed Consent Process Note | SOP-04 | Word |
| F-301-02 | Consent Form Version Control Log | SOP-04 | Word |
| F-302-01 | Delegation of Authority Log | SOP-02 | Word |
| F-303-01 | Screening and Enrollment Log | SOP-05 | Word |
| F-303-02 | Eligibility Verification Checklist | SOP-05 | Word |
| F-304-01 | Investigational Product Accountability Log | SOP-06 | Word |
| F-304-02 | Temperature Monitoring Log | SOP-06 | Word |
| F-304-03 | Temperature Excursion Report | SOP-06 | Word |
| F-304-04 | Participant IP Dispensing and Return Log | SOP-06 | Word |
| F-305-01 | Emergency Unblinding Record | SOP-05 | Word |
| F-306-01 | Note to File | SOP-03 | Word |
| F-308-01 | Protocol Deviation Log | SOP-08 | Word |
| F-309-01 | Participant Contact and Retention Log | SOP-10 | Word |
| F-310-01 | Participant Payment Log | SOP-10 | Word |
| F-311-01 | Specimen Processing and Shipment Log | SOP-11 | Word |
| F-312-01 | Equipment Inventory and Calibration Log | SOP-11 | Word |
| F-400-01 | Privacy Incident Report | SOP-12 | Word |
| F-401-01 | Computerized System Inventory and Access Log | SOP-12 | Word |
| F-402-01 | Record Archiving and Retrieval Log | SOP-12 | Word |
| F-500-01 | Adverse Event Assessment Worksheet | SOP-09 | Word |
| F-501-01 | SAE Reporting Tracker | SOP-09 | Word |
| F-502-01 | Reportable New Information Assessment | SOP-09 | Word |
| F-503-01 | Pregnancy Report Tracker | SOP-09 | Word |
| F-600-01 | Monitoring Visit Log | SOP-13 | Word |
| F-600-02 | Monitoring Follow-Up Action Tracker | SOP-13 | Word |
| F-601-01 | Study Closeout Checklist | SOP-15 | Word |
| F-700-01 | Internal QC Review Checklist | SOP-14 | Word |
| F-700-02 | Annual Audit Plan and Audit Report | SOP-14 | Word |
| F-702-01 | Inspection Request and Document Log | SOP-13 | Word |
| F-703-01 | CAPA Record | SOP-08 | Word |
| F-703-02 | CAPA Log | SOP-08 | Word |
| F-705-01 | Business Continuity Plan and Emergency Contacts | SOP-16 | Word |
| F-105-01 | Service Provider Qualification and Oversight Record | SOP-M1 | Word |
| F-200-01 | Study Feasibility Assessment | SOP-M2 | Word |
| F-201-01 | Contract and Budget Review Checklist | SOP-M2 | Word |
| F-202-01 | Coverage Analysis Worksheet | SOP-M2 | Word |
| F-300-02 | Recruitment Material Tracking Log | SOP-M3 | Word |
| F-313-01 | Remote Visit and Home Health Visit Record | SOP-M4 | Word |
| F-704-01 | Integrity Concern Report | SOP-M5 | 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.
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.