Adoption Guide (Lean Edition)

Status and use

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.

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.

1. What is included

The Lean Edition holds steps only. The Reference Edition (48 SOPs, release 1.3) holds the regulatory background, the longer explanations and the source wording; each Lean SOP names its Reference Edition source in section 7. A site that operates as a network adds the Network Edition (SOP-N1 to SOP-N6, the Network Supplement and the exceptions table) on top of this core. Nothing in the Lean Edition depends on the Network Edition.

2. Deciding which modules apply

Decide this first, because it changes the decision register, the [DEFAULT] values and the training plan. A module is adopted only when the site performs the activity. Record each module as adopted or not adopted on F-100-03 (SOP-01, 5.4.5 and 5.7.1). A module that is not adopted is not trained or audited; the right-hand column states what the site does instead. Most independent sites will 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: the 16 core SOPs, SOP-M1, SOP-M2 and often SOP-M3. The trigger in the middle column is the module's own Scope sentence.

Module dependencies. SOP-M3 (recruitment vendors), SOP-M4 (site-engaged home health, courier or telehealth vendors), SOP-M6 (consultants, CROs and other providers for sponsor functions) and the SOP-M2 coverage analysis vendor all use SOP-M1 for any outside provider. Engaging such a provider meets the SOP-M1 trigger, so a site adopting one of these modules adopts SOP-M1 before it engages the provider. SOP-M6 records its resourcing decision on F-200-01; a site that adopts SOP-M6 without SOP-M2 adopts F-200-01 with SOP-M6 and uses it for that decision only.

3. Effort estimate

This is an estimate. No site has adopted the Lean Edition yet, so none of these figures has been measured. The reading figures come from the actual word counts of this release at 200 words per minute. The other figures are stated per item so a site can scale them to its own pace.

For the core alone, the Quality Lead's configuration work (reading, placeholders, decisions, defaults, forms, one state in Appendix A, alignment and routing) comes to roughly 25 to 30 hours. All six modules add about 4.4 hours. The rows for the independent reviewer, counsel, the PI and Site Director, equipment, covering investigators and trainers are other people's time and are not in that figure; they are estimates with ranges, not measurements. The effective date usually waits on counsel, the independent reviewer and, where needed, temperature monitoring equipment, not on Quality Lead hours, so start those in the first week. With the 30-day wait before the effective date, a site working on this part time should plan on two to three months from start to effective date.

Role-based training estimate. Built from the core rows of the role matrix in Start Here (edition.json). For each SOP marked "Read and train": reading the whole SOP at 200 words per minute plus 15 minutes to discuss and sign F-100-02, and 30 minutes more for SOP-04, SOP-06, SOP-08 and SOP-09, which need a trainer-led session or knowledge check (SOP-01, 5.4.2). For each SOP marked "Know where it is": 5 minutes.

Add the reading time of each adopted module (10 to 17 minutes) for the roles the module rows of the matrix mark, for example SOP-M2 for the Finance / Contracts Lead and SOP-M4 for CRCs who run remote visits. A person holding several roles trains once on each SOP at the highest level any of their roles needs; their hours are not the sum of the rows.

4. Step-by-step adoption

Step 1. Name the Quality Lead and the independent reviewer

The Site Director names the Quality Lead, who runs the adoption and owns the SOP system afterwards (SOP-01). The Site Director also names the independent reviewer now, not when a conflict arises (SOP-02, 5.2 and decision L-02 below). The reviewer must not be employed by or report to the owner, PI or Site Director. A small site uses this person for reviews of its leaders' own work, the annual internal audit, fallback consent QC (SOP-14, 5.4.2), the anonymous integrity route (SOP-M5, if adopted) and the approvals SOP-01, 5.3.5 sends to it (Step 7). Record both on F-102-01.

At most small sites the independent reviewer is an outside person. People who usually qualify:

• an independent GCP or clinical QA consultant
• the QA lead at a peer site, often under a reciprocal arrangement in which each site reviews the other
• a retired CRA, monitor or GCP auditor

The person needs GCP training, working knowledge of site operations and no employment, ownership or reporting tie to the owner, PI or Site Director. Record the engagement in a letter or agreement filed in the quality file (or on F-105-01 if SOP-M1 is adopted) that states the services, the expected annual hours (see the effort estimate, section 3: about 20 to 40 hours a year), the turnaround for each SOP clock the reviewer serves (for example 10 business days for fallback consent QC), the fee or hourly budget, confidentiality terms or a BAA for access to participant records, and how the reviewer's training is recorded on F-103-01. The answer goes in decision L-02.

Step 2. Replace the placeholders

Placeholders are capitalized text in square brackets. Replace the site-wide ones across all SOPs and forms first: [SITE NAME], [SITE LEGAL NAME], [CENTRAL IRB NAME], [STATE], [LEGAL COUNSEL], [IT SUPPORT PROVIDER], [PRIVACY OFFICER NAME], [SECURITY OFFICER NAME]. Placeholders that name a tool or location ([IRB TRACKER], [CONTRACT TRACKER], [CONTRACTS FOLDER], [SOP REPOSITORY LOCATION], [QUALITY FILE LOCATION], [DOWNTIME FORMS LOCATION], [PRACTICE MANAGEMENT SYSTEM] where the site bills clinical care) get the actual system or folder; if the site has none, decide what it will use before the effective date.

Generic placeholders such as [DATE], [NAME], [N] and [ROLES] mean different things in different places. Resolve each one in place, reading the sentence around it, and never with a global replace. Placeholders inside a Site decision box are resolved in Step 3.

When finished, search for the opening square bracket. No placeholder, Site decision box or [DEFAULT] marker may remain in an approved SOP (SOP-01, 5.7.2).

Step 3. Decide every Site decision

The Lean core has 15 Site decision boxes and the modules have 5, 20 in all. Each is a real choice the library cannot make for the site. The Quality Lead takes each question to the person who owns it (usually the PI or Site Director, with counsel for L-12 and L-19), records the answer in the register below, and then replaces the box with the resulting text. Delete the module rows for modules not adopted. Keep the completed register in the quality file; sponsors and auditors may ask how a choice was made.

L-10 and SOP-02, 5.5.2 work together: a nurse practitioner or physician assistant Sub-I assesses AEs only if L-10 allows it.

Step 4. Confirm the [DEFAULT] values

A [DEFAULT] tag marks a value the library chose because no regulation sets it (for example a number of business days or a sample size). The core SOPs hold 125 tags and the modules 25; the forms repeat 81 of these values (68 on core forms, 13 on module forms). Search the SOPs and the forms for "[DEFAULT:" and, for each tag, either accept the value or replace it with the site's value. In both cases remove the tag, so the approved text reads as a plain commitment.

Keep forms and SOPs equal. Where a form repeats a value (a review time, a sample size, a deadline column), the form value must be the same as the SOP value. Change both together, and record the change on F-100-01 with the SOP.

Before changing a recurring check, read the quality calendar in SOP-14, 5.1. Every recurring check in this library is listed there: Part A holds the periodic checks and Part B the checks repeated at each monitoring visit, consent, invoice, restock or other recurring event, each with its owner, record and home SOP. A site that wants a different cadence changes the calendar row and the home SOP together, and a site that adds a new recurring check adds it to the calendar first. These twelve defaults have the most effect on workload and inspection risk:

Step 5. Complete Appendix A

Complete one Appendix A worksheet for each state where the site has a location and each state where participants are seen remotely or receive home visits. Do it with counsel, and confirm the research answers (LAR authority, age of majority, state consent documents) with the IRB of record. Give a copy to everyone who obtains consent. The SOPs point to Appendix A wherever state law decides the answer, so the SOPs are not complete until it is.

Step 6. Align with the IRB and key sponsors

The Regulatory Coordinator completes the F-502-01 IRB page for the IRB of record (SOP-09, 5.1.2): reportable-event categories, windows exactly as the IRB states them, and submission route. F-205-01 then confirms that page and records what the IRB requires for personnel and location changes, deviations, continuing review and closure (SOP-03, 5.1.3). Check the consent, eConsent and remote consent methods the site intends to use against IRB policy (L-06, L-07).

For the two or three sponsors the site works with most, compare their usual requirements with the site's choices: SAE timelines and backup methods, monitor access to the EHR (L-13), eligibility and consent documentation, and internal audit report sharing (SOP-14, 5.7.7). The protocol, sponsor or IRB requirement wins where it is stricter (SOP-01, section 2), so differences are handled study by study, not by editing the SOPs.

Step 7. Approve under SOP-01

Approve each SOP on F-100-01 (SOP-01, 5.3.4): the author (for adoption, the Quality Lead who configured it), the Quality Lead, the Site Director, and the clinical approver (library default: the lead PI) for SOPs that affect investigator duties, safety, consent, IP or data integrity. Approve the forms with their parent SOP.

No one is the only approver of an SOP they wrote (SOP-01, 5.3.5). At a small site the author, Quality Lead and Site Director are often one person; a second person then approves. Under SOP-01, 5.3.5 as written that is the PI, and it is the independent reviewer when the same person is also the PI. A site that wants the independent reviewer to approve whenever the author, Quality Lead and Site Director are one person, even where a separate PI exists, changes SOP-01, 5.3.5 to say so before approval.

Record on F-100-03 the modules adopted and not adopted and the prior site SOPs each new SOP replaces (SOP-01, 5.7.1). Version numbering starts at 1.0.

Step 8. Train by role

Assign training on F-103-01 by the role matrix in Start Here. "Read and train" means the person reads the SOP and signs F-100-02 before the effective date; for SOP-04, SOP-06, SOP-08 and SOP-09 it also means a trainer-led session or a short knowledge check (SOP-01, 5.4.2). "Know where it is" means the person knows the SOP exists, what it covers and where to find it. Add each adopted module for the roles its row marks. Module roles outside the matrix read and train on their module: the Provider Owner (SOP-M1); the feasibility owner and billing staff or billing service (SOP-M2); the Recruitment Specialist and Privacy Officer (SOP-M3). Competency checks under SOP-01, 5.10 (for example observed consents) are separate from SOP training and are recorded on F-103-01.

Training on the inspection conduct steps (SOP-13, 5.6) is part of every staff member's SOP training.

Step 9. Set the effective date

The Quality Lead sets the effective date at approval, at least 30 calendar days later for adoption unless the site changed that default (SOP-01, 5.4.1). Before that date, the Quality Lead checks training completion and either moves the date or restricts untrained staff from the tasks the SOP covers (SOP-01, 5.4.3). On the effective date, the Quality Lead publishes the SOPs in [SOP REPOSITORY LOCATION], withdraws the site's prior SOPs from use and archives them marked "SUPERSEDED" (SOP-01, 5.5.3).

In the first quarter, the Quality Lead sets up the year's quality calendar in the quality file from SOP-14, 5.1 Part A, writes a study QC plan for each active study (SOP-14, 5.2) and schedules the first quarterly review. Studies already running move to the new SOPs on the effective date unless a protocol or sponsor requirement says otherwise; record any exception on F-306-01.

5. Keeping it current

Periodic review. The Quality Lead reviews each SOP at least every 2 years (or the site's chosen period) and sooner after a regulatory change, a significant finding, a CAPA, a new type of study or system, or recurring SOP deviations (SOP-01, 5.5). Due dates are on F-100-03. Changes go through SOP-01, with training before the new version takes effect.

Regulatory Currency Note. The note lists items whose status may change (for example FDA adoption of ICH E6(R3) Annex 2 and the proposed single IRB and key information rules). Re-check it as an input to the annual management review (SOP-14, 5.8.2, regulatory changes), and at once when one of its items changes status. Review Appendix A at the same meeting. This keeps both reviews on an existing calendar date instead of adding new recurring checks. Record each check on F-100-01 and open SOP revisions where an item has changed.

Library updates. AIMR posts later releases and their release notes at aimronline.org/sops, which is also where to send feedback. A later release does not change the site's adopted SOPs. The Quality Lead compares the release notes with the site's text and adopts changes through SOP-01 like any other revision.

6. What is excluded

The Lean Edition is written for the work of a single independent investigator site. Sites that do the following work need separate procedures.