Adoption Guide

Status and use

• What it is. This library was prepared as a configurable template of SOPs, forms and guides. It is not a finished quality system until a site configures, approves and trains on it.
• Review status. Not reviewed by counsel or by a practicing site QA lead as of [DATE]. No site has yet adopted the library, so no adoption time or effort figure in this guide has been measured.
• Open items. The network points on the Anti-Kickback Statute, the physician self-referral (Stark) law, DEA registration and HIPAA structure (SOP-902, SOP-904, SOP-905), and whether a Network Office may run feasibility queries on a member site's data under a business associate agreement (SOP-200 Network note), are open questions for counsel.
• Not legal advice. The library describes operating steps. It is not legal advice. The adopting site confirms law, IRB requirements and sponsor requirements with its own counsel and reviewers.
• Ownership. Once the site approves the library under its own signatures, the adopting site owns every word of it and answers for it to sponsors, IRBs and inspectors.

1. What this library includes

This library is a configurable template of SOPs, forms and guides written for an independent US clinical research site running industry-sponsored drug, biologic and device trials under a central IRB. It covers the investigator-site work described in the SOPs and excludes the areas listed in section 7. Version 1.1 adds a network layer so the same library can run a network of sites under a central Network Office. It is written to ICH E6(R3) and current FDA regulations. A site adopts it by filling in its own details, making the decisions the templates leave open, approving it under its own signatures and training staff before it takes effect.

Three markers in the SOPs need action at adoption:

• Placeholders in square brackets and capitals, for example [SITE NAME], [CENTRAL IRB NAME], [STATE]. Replace each with the site's information.
• Site decision boxes. Each one names a choice the site must make and record, for example which roles may obtain consent.
• [DEFAULT: ...] values, for example [DEFAULT: 2 business days]. The library sets a starting value. The site confirms it or changes it, then removes the marker.

2. Choose your operating model

Decide first whether the library will run one site or a network. The choice changes who approves SOPs, who does central work and which documents apply. Record it in the operating model Site decision in SOP-100 (5.10.1.1). Model S also records it on F-100-03 SOP Master Index and Review Schedule; Model N records it on F-900-02 Network Operating Model and Appendix B Adoption Record.

Points that decide the variant:

• Who owns each site, and who employs the staff.
• Whether there is one HIPAA covered entity, an affiliated covered entity, or separate covered entities.
• Who signs clinical trial agreements and receives sponsor payments.
• Separate companies under common ownership: N-Integrated defaults apply only where the member site and the network entity are the same legal entity. A separate subsidiary, or a professional corporation under a management services arrangement, follows the N-Affiliated rows for PHI, direction of staff, contract signature, records custody and payments unless counsel confirms otherwise (SOP-900, 5.2.1).

In every model, each PI keeps the investigator duties for the PI's studies at the PI's site. A network can centralize work around the PI; it cannot take the PI's duties.

3. Before you start

No site has yet adopted the library, so there is no measured adoption time. The figures below are an estimate of the effort by task, for planning only:

• reading: about 13 hours for the Quality Lead to read the core SOPs, the guides and the appendices once (about 150,000 words at 200 words a minute)
• Site decisions and defaults: [N] meetings of the Quality Lead with the PI, Site Director and Finance / Contracts Lead to resolve every Site decision (Step 3) and confirm every default (Step 4)
• Appendix A: counsel time for each state where the site has a location or sees participants (Step 5)
• approvals: one F-100-01 approval record per SOP, with the signatures in Step 8
• training: [N] hours per role, set from the role-based SOP assignment in Step 9

Plan for:

• a Quality Lead with time set aside (see Step 1)
• the PI or PIs, for decisions about investigator duties, consent, safety and delegation
• the Regulatory Coordinator, for IRB, ISF and essential records decisions
• the Finance / Contracts Lead, for contracts, coverage analysis and payment decisions
• counsel, for Appendix A
• the central IRB's investigator manual and state-law guidance
• the SOP requirements in the site's current clinical trial agreements and master agreements with its main sponsors and CROs
• the site's existing SOPs, if any, so they can be mapped and retired

4. Step-by-step adoption (Model S, and each member site in Model N)

Step 1. Assign the Quality Lead and approve an adoption plan

The Site Director names the Quality Lead in writing and records on F-102-01 Site Organization Chart and Role Assignment Record who holds every standard role (SOP-102): PI and Sub-Is, Regulatory Coordinator, Lead CRC and CRCs, Research Pharmacist or IP Manager, Finance / Contracts Lead and Quality Lead, with a named backup for each critical role. The Site Director also names the people who will hold the roles that some SOPs add to the standard list: Privacy Officer and Security Officer (SOP-400), a System Owner for each computerized system (SOP-401, F-401-01) and a Provider Owner for each service provider (SOP-105, F-105-01). The Quality Lead owns the SOP system (SOP-100 Writing, Approving and Controlling SOPs). At a small site the Quality Lead may also be the Site Director or hold another role, but the Quality Lead does not QC their own work (SOP-102 Site Organization, Roles and Staff Responsibilities). Where the Site Director is also the Quality Lead, reviews of the Site Director's own work or decisions go to the PI or, where the owner, PI and Site Director are the same person, to the independent reviewer named in the SOP-102 5.3 Site decision, who must not be employed by or report to that person. The Site Director approves a short adoption plan with target dates for each step below and the planned effective date.

Step 2. Replace the placeholders

The Quality Lead runs a find-and-replace for each site-wide placeholder across all SOPs and forms. Start with the common ones: [SITE NAME], [SITE LEGAL NAME], [CENTRAL IRB NAME], [STATE], [LEGAL COUNSEL], [PRIVACY OFFICER NAME], [SECURITY OFFICER NAME]. [SITE LEGAL NAME] and [LEGAL COUNSEL] are the standard names for the site's legal entity and its counsel throughout the library. Generic placeholders such as [DATE], [NAME], [N], [ROLES], [METHOD] and [FREQUENCY] mean different things in different places: resolve each one in place, reading the sentence around it, and never with a global replace. Then search for any remaining text in square brackets and capitals and resolve each one. Some placeholders name a tool or location (for example [IRB TRACKER], [CONTRACT TRACKER], [ACCOUNTING SYSTEM]); write the actual system or folder the site uses. If the site has no such tool, decide what it will use before the effective date.

When finished, search once more for the opening square bracket. No placeholder should remain in an approved SOP.

Step 3. Decide every Site decision and record it in the decision register

The library has 56 Site decision boxes, and the register below has one row for each. D-01 to D-48 apply to every site: 47 core decisions from version 1.0 plus the operating model decision (D-48) added in version 1.1. D-49 to D-56 sit in the network SOPs (SOP-900 to SOP-905) and apply only in Model N; a Model S site deletes those rows. In Model N, the Network Quality Lead also records on F-900-02 whether each decision is resolved once for the network or by each member site (SOP-900, 5.4.4); a decision resolved per site is recorded in that site's register and, where it changes SOP text, in a local addendum (F-900-01). For each one, the Quality Lead brings the question to the person named in the box (usually the PI or Site Director), records the decision, and then either writes the decision into the box or replaces the box with the resulting procedure text (SOP-100). Keep a decision register so the site, sponsors and auditors can see what was decided and by whom.

Delete the rows for SOPs the site marks not applicable (Step 7), and add a row for any decision a later revision introduces. File the register with F-100-03 SOP Master Index and Review Schedule.

Step 4. Confirm the [DEFAULT] values

Each [DEFAULT: ...] value is a timeline, frequency or threshold that the regulations do not set. The library chose a workable starting value. For each one, the Quality Lead asks: can the site meet this every time, and does any sponsor contract or IRB policy require something stricter? Then the Quality Lead confirms or changes the value and removes the DEFAULT marker. Record changed values in the decision register.

The table lists the defaults that most affect daily workload. At this version the SOPs contain 246 [DEFAULT: ...] tags (119 distinct values) and the forms contain 104 more, 350 in all. Search every SOP and every form for "[DEFAULT:" and record any value the site changes in this table or the decision register. Where a form repeats a value from its SOP, set the form to the same value as the SOP.

A default the site cannot meet is worse than a longer timeline it can. Inspectors and auditors check the site against its own SOPs.

Step 5. Complete Appendix A for each state

The Quality Lead completes Appendix A State Law Worksheet with counsel for every state where the site has a location, and for every state where participants are seen by telehealth or home visits. Confirm the research answers (who may serve as a legally authorized representative, minors, state research laws) with the IRB of record. The California, Maryland and New York entries in Appendix A are illustrations only. Verify before relying on them.

Step 6. Check alignment with the IRB and key sponsors

The library defers to the protocol, sponsor and IRB where they are stricter. Before approval, the Quality Lead and Regulatory Coordinator check the SOPs against:

• the central IRB's investigator manual, especially reportable-event categories and windows (SOP-502), consent documentation (SOP-301) and personnel change notices
• any SOP or quality requirements in the site's master agreements with its main sponsors and CROs
• each sponsor's requirements for logs: where a sponsor requires its own delegation, accountability or deviation log, the SOPs allow it, but the site should know in advance which studies use which logs

Record each conflict and how it was resolved. Where the conflict will apply to most studies, change the SOP. Where it applies to one study, a note to file (F-306-01) is enough.

Step 7. Remove what does not apply

Mark as not applicable any SOP or section for work the site does not do (for example SOP-800 Sponsor-Investigator Responsibilities if the site never holds an IND or IDE, or the controlled-substance sections of SOP-304 if it never stores controlled IP). Record each decision and the reason on F-100-03. Remove only what the site truly never does. If a sponsor later offers a study that needs a retired section, reinstate it through SOP-100 before the study starts.

Step 8. Approve the library on F-100-01

Each SOP is approved on F-100-01 SOP Review and Approval Record, signed by the author (the Quality Lead for the adoption), the Quality Lead, the Site Director and the clinical approver decided in Step 3. Because no one may be the only approver of an SOP they wrote, where the Quality Lead who wrote the SOP is also the Site Director, the PI or a qualified external reviewer also approves (SOP-100, 5.4.4). All SOPs may share one approval date and one effective date. Version numbering starts at 1.0. The Quality Lead records each SOP on F-100-03, maps any old site SOP to its replacement, and retires the old SOPs on the effective date (SOP-100).

Step 9. Train staff on F-100-02 before the effective date

The Quality Lead assigns SOPs to each role (SOP-103 Staff Qualification, Training and Training Records). Each person reads the assigned SOPs and signs F-100-02 SOP Training Acknowledgment before the effective date. For SOPs that need a demonstration (consent, IP handling, specimen shipping), training includes the demonstration. Set the effective date at least [DEFAULT: 14 calendar days] after approval, and move it if training is not finished. Nobody works under an SOP they have not been trained on.

Step 10. Set the review schedule on F-100-03

The Quality Lead enters the next review date for every SOP on F-100-03 (every [DEFAULT: 2 years] from the effective date), sets Appendix A for annual review, and sets the Regulatory Currency Note check for annual review. Tell sponsors and the IRB that the site has a new SOP set when they ask or when a contract requires notice.

5. Model N adoption path

A network adopts the library once at network level, then each member site adopts it for itself. Follow the steps in section 4 at each member site, with these changes and additions.

Step N1. Set up the Network Office and choose the variant

The Network Executive names the Network Quality Lead and the other Network Office roles the network will use, charters the Network Quality Committee, and records the variant, its legal basis, the member entities and locations, and the HIPAA arrangement across sites on F-900-02 (SOP-900 Network Governance, SOP Hierarchy and Local Addenda). N-Affiliated: confirm with counsel that the network agreement states which SOPs and Appendix B assignments bind each member entity, the Network Office's audit and data rights, and what happens when a network SOP conflicts with a member's legal duties (SOP-900 5.9).

Step N2. Adopt the library at network level

The Network Office adopts the library as the network SOP set. The Network Quality Lead replaces network placeholders (for example [NETWORK NAME], [NETWORK GOVERNING BODY CONTACT]), marks the network minimums, decides which Site decision boxes are resolved once for the network and which per site, and records each on F-900-02. Network SOPs are approved on F-100-01 by the Author, the Network Quality Lead, the Network Executive and, where an SOP assigns investigator duties, the Network Medical Director or a PI the Network Office names (SOP-100 5.11.3).

Step N3. Complete Appendix B

The Network Quality Lead completes Appendix B Central and Site Responsibility Matrix with the other Network Office leads and at least one member site PI. Start from the default for the variant, record each change and its reason on F-900-02, and never move a row marked Yes in the Must stay at site? column away from the site. N-Affiliated: assign a row to the Network Office only where the network agreement gives that authority. The Network Quality Committee approves F-900-02 and each member Site Director signs it.

Step N4. Each member site completes Appendix A and its local addenda

Each member site completes Appendix A for every state where it has a location or sees participants remotely. The Network Quality Lead may prepare one worksheet per state for all sites in that state; each site confirms it (Appendix B, SOP-100 rows). Each site then writes the local addenda it needs on F-900-01 for state law, local IRB or hospital requirements, local systems and contacts, and any Site decision assigned to the site. The Network Quality Lead checks each addendum against the limits in SOP-900 5.5.2 before the site approves it.

Step N5. Adopt and train at each member site

Each member site records adoption of the network SOP set on F-100-01 (Site Director and Site Quality Lead) and trains its staff on the network SOPs, its local addenda and its role in Appendix B before the effective date. Shared staff and Network Office staff who work on a site's studies are trained on that site's local addenda and recorded on F-904-01 (SOP-904 Shared Staff, Cross-Site Coverage and Central Services). Each Site Director confirms in writing to the Network Quality Lead that training is complete.

Step N6. Set effective dates

The Network Quality Lead sets one network effective date, at least [DEFAULT: 30 calendar days] after approval for a major revision (SOP-900 5.7). A site that cannot finish training in time gets a later site effective date recorded on F-100-03, of up to [DEFAULT: 30 calendar days]. Until then that site keeps working under its current SOPs. Sites that join later follow SOP-901 Member Site Onboarding, Integration and Exit, with their own effective date set in F-901-02.

Step N7. Start network oversight

Set up the network data flow register (F-905-01), the shared systems section of F-401-01, the metric set and scorecard (F-903-01), and the first network audit plan approved by the Network Quality Committee (SOP-903 Network Oversight of Member Sites (Metrics, Central QA, Escalation)).

6. Example rollout schedule

The day ranges below are an example for planning, not a measured duration. Adjust them to the effort estimate in section 3 and the site's staffing.

For a network, use this variant. It assumes the member sites are already operating and adopt together.

Active studies continue during adoption. On the effective date, new SOPs apply to ongoing work from that day forward. Records made before the effective date are not redone.

7. What this library leaves out

The library is written for the work of an independent investigator site. It excludes the following. Sites that do this work need separate procedures.

8. Points that are easy to misread

Check these with the Regulatory Currency Note before approval:

• 10-year claims records (SOP-202). The [DEFAULT: 10 years] retention for research billing records is a conservative site choice set to cover the False Claims Act limitations period. No regulation requires the site to keep claims records for 10 years. Change it if counsel advises a different period.
• Debarment and exclusion screening (SOP-103, SOP-105, SOP-704). Screening staff and providers is site practice that supports contract certifications. It is not an FDA requirement.
• GCP refresher interval (SOP-103). No regulation sets one. 3 years is a sponsor convention.
• DEA telemedicine prescribing (SOP-313). The temporary DEA and HHS flexibilities for prescribing controlled substances after a telemedicine visit were extended through 31 December 2026. A permanent rule was not final at the date of the Currency Note. Confirm the rules in force before relying on them.
• FDA single IRB and Common Rule harmonization (SOP-203, SOP-301). FDA's 2022 proposed rules on single IRB review for cooperative research and on harmonizing 21 CFR 50 and 56 with the Common Rule (including a key information section) are proposed, not final. The SOPs say "if and when finalized".
• Single IRB for networks (SOP-203, SOP-800). A network running one protocol at several member sites will feel FDA's proposed single IRB rule for cooperative research more than a single site will. It is proposed, not final. Federally funded cooperative research already needs a single IRB under the Common Rule (45 CFR 46.114), and in N-Affiliated each member entity engaged in the research signs the reliance agreement.
• Remote regulatory assessments (SOP-702). Most RRAs are voluntary, but a records request under FD&C Act section 704(a)(4) is mandatory. The site must provide the records within the time FDA sets.
• Form FDA 1572 updates (SOP-101, SOP-205). A new signed 1572 is needed only when a new PI takes over the study or a new protocol is added (FDA Form FDA 1572 FAQs, 2010). Other changes (a new Sub-I, laboratory or location) are recorded and sent to the sponsor; a new form is needed only if the sponsor asks.

9. Keeping the library current

The Quality Lead owns currency. The routine is:

• Periodic review. Each SOP is reviewed at least every [DEFAULT: 2 years] and the outcome recorded on F-100-01 (SOP-100).
• Triggered review. Revise an SOP when a regulation or guidance changes, an inspection or audit finds a gap, a CAPA requires it, a recurring sponsor requirement conflicts with it, or practice has changed. Record the trigger on F-100-01.
• Regulatory watch. At least [DEFAULT: quarterly], the Quality Lead checks FDA's guidance and Federal Register pages, ICH's E6 page, the central IRB's announcements and the state items in Appendix A. Record what was checked and whether any SOP is affected.
• Regulatory Currency Note. Re-check every item in the note at least [DEFAULT: annually] and when a listed item changes status (for example a proposed rule becomes final). Update the note's date.
• Appendix A. Review each state worksheet at least [DEFAULT: annually] and whenever the site adds a state.
• Forms. Change forms only through SOP-100. Keep form codes stable so cross-references in SOPs stay correct.
• Lessons from use. Collect SOP deviations, monitoring findings and staff questions. Trends reviewed at least [DEFAULT: quarterly] (SOP-100) are the best signal that an SOP needs to change.