Independent Site SOP Library
Free, editable standard operating procedures, forms and guides that a US clinical research site can adapt and approve as its own.
What it is
A configurable template set of SOPs, forms and guides for US clinical research sites, written to the ICH E6(R3) baseline as of 23 October 2026 (the date in the Regulatory Currency Note). The files are Word documents. A site reads them, changes them to match how it actually works, and approves them under its own SOP control process.
Two highlight colors mark what the site has to decide: [YELLOW] marks a value the site fills in, and [DEFAULT: green] marks a value the library suggests that the site may keep or change. Shaded Site decision boxes are choices the site records in the Adoption Guide decision register.
Who it is for
- A small independent site running FDA-regulated drug, biologic or device trials for industry sponsors: use the Lean Edition.
- A site network (a network office plus two or more member sites): use the Lean Edition for every site and add the Network Edition.
- Anyone who wants the longer text, the regulatory background or the source wording behind a Lean step: use the Reference Edition.
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.
Three editions
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.
16 core SOPs, 6 optional modules, 50 forms, 3 guides
Network Edition 2.0
An add-on for site networks: 6 network SOPs, a supplement listing what changes in each Lean SOP, and a table of activities a network may centralize. It does not stand alone; every member site also uses the Lean Edition.
6 network SOPs, 10 forms, 2 guides
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.
48 SOPs, 59 forms, 4 guides
Download all three editions in one zip (8.3 MB). Every zip includes the license.
How to start
For a single site using the Lean Edition:
- 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.
Networks follow the extra steps on the Network Edition page.
Status and limits
Read this before you use any of these documents.
- Not legal advice. These templates describe operating procedures. They do not give legal advice. Each adopting site confirms state law (Appendix A), IRB and sponsor requirements, and any legal or contracting position with its own counsel before approval.
- No outside expert review yet. No lawyer and no practicing site QA lead has reviewed these templates.
- Not yet used by a site. No site has adopted the library, so nothing in it has been tested in daily operation.
- The adopting site owns it. Once a site approves these documents they are its own SOPs, and the site is responsible for every step it approves. Change or remove any step the site will not follow before approval.
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.
License
The library is licensed under Creative Commons Attribution-NonCommercial 4.0 (CC BY-NC 4.0), with one added permission: any research site, site network, sponsor-investigator or institution, including a for-profit one, may copy, adapt and use the templates as its own internal procedures and forms.
Selling, licensing or repackaging the templates, or delivering them as a paid consulting deliverable to another organization, needs written permission from AIMR.
Attribution line:
Adapted from the Independent Site SOP Library by the American Institute for Medical Research (AIMR), aimronline.org/sops, CC BY-NC 4.0.
A site may keep the attribution in an internal record, such as its SOP master index, rather than on every document.
Tell us what you'd change
If a step does not match how a site really works, a citation looks wrong, or a form is missing a field, tell us. Use the feedback button at the bottom right of any page, or the button below. Say which edition and document you mean, and the section number if there is one.
Version and date
Lean Edition 2.0, Network Edition 2.0, Reference Edition 1.3. Regulatory baseline: 23 October 2026. Source text last changed 1 November 2026. The library is published by the American Institute for Medical Research (AIM Research), a registered 501(c)(3) nonprofit.