Guide
Regulatory Currency Note
- Edition
- Reference Edition 1.3
- Approx. pages
- 4
[YELLOW] the site fills in. [DEFAULT: green] a value the site may keep or change.
On this page
Status and use
This note is part of a configurable template library. It has not been reviewed by counsel or by a practicing site QA lead as of 1 November 2026, and no site has yet adopted the library. It records the regulatory baseline the library was written against; it is not legal advice. The adopting site confirms each item against current primary sources and with its own counsel before relying on it, and owns the adopted text once approved.
1. Purpose
This note records the regulations, guidance and standards this library was written against, as of 23 October 2026, and lists items whose status may change. The Quality Lead reads it at adoption, re-checks every item at least [DEFAULT: annually], and re-checks an item at once when its status changes. Record each check on F-100-01 SOP Review and Approval Record and update the date of this note.
2. Baseline and items to re-check
| Item | Status on 23 October 2026 | What the library does | Site action |
|---|---|---|---|
| ICH E6(R3) Good Clinical Practice | ICH Step 4 adopted 6 January 2025. FDA published it as final guidance in September 2025 (Federal Register notice of availability, 9 September 2025). | Written to E6(R3) structure and vocabulary: participant, essential records, service provider, risk-proportionate, critical to quality factors. Cites Annex 1 sections by number. | None, unless FDA or ICH issues an erratum or revision. |
| ICH E6(R3) Annex 2 (decentralised elements, pragmatic trials, real-world data) | ICH Step 4 on 3 June 2026. EU effective 15 January 2027. FDA issued the draft for comment (December 2024, comment period reopened March 2025). No FDA final guidance notice found in the Federal Register as of this date. | Cited as "ICH E6(R3) Annex 2 (ICH Step 4, June 2026)". SOP-313 follows FDA's 2024 decentralized trial guidance and is consistent with Annex 2. | Check whether FDA has published Annex 2 as final guidance. If so, review SOP-313, SOP-301 (remote consent) and SOP-401. |
| FDA proposed rule: Protection of Human Subjects and Institutional Review Boards (Common Rule harmonization, including a key information section in consent) | Proposed 28 September 2022. Not final as of this date. | Says "if and when finalized". Notes that many IRBs already require a key information section. | Check for a final rule. If final, review SOP-301 and SOP-203 and consent templates. |
| FDA proposed rule: Institutional Review Boards; Cooperative Research (single IRB for multisite FDA-regulated studies) | Proposed 28 September 2022. Not final as of this date. Secondary sources report that the 2026 Unified Agenda lists a target final-rule date of December 2026; confirm on the Unified Agenda. | SOP-203 says the rule is proposed and applies only if and when finalized. Assumes a central IRB as the normal case, so little changes for most single sites. Model N networks are more exposed: a network study at several member sites would be cooperative research, and in N-Affiliated each member entity would sign reliance agreements (SOP-203 and SOP-800 Network notes). | Check for a final rule. If final, review SOP-203, SOP-800, reliance agreements and, in Model N, the SOP-203 rows of Appendix B. |
| FDA final rule: IRB waiver or alteration of informed consent for minimal-risk clinical investigations | Final rule published 21 December 2023 (21 CFR 50.22). | SOP-301 points to the IRB's determination when consent is waived or altered. | None. |
| ISO 14155 (clinical investigation of medical devices) | Standards catalogues list ISO 14155:2026 (edition 4, published March 2026), replacing the 2020 edition. | Cited as "ISO 14155 (current edition)". The 2011 edition is never cited. | Confirm the edition named in each device sponsor's protocol and agreements. Note that sponsors may still reference 2020 during transition. |
| 21 CFR 820 Quality Management System Regulation (QMSR) | Took effect 2 February 2026, replacing the Quality System Regulation and incorporating ISO 13485 by reference. | Not cited in site SOPs except where a site acts as device sponsor-investigator (SOP-800). | None for most sites. |
| FDA guidance: Conducting Clinical Trials With Decentralized Elements | Final, September 2024. | Basis of SOP-313. | Check for revisions, and for any FDA adoption of Annex 2 that supersedes it. |
| FDA guidance: Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations, Questions and Answers | Final, October 2024. | Basis of SOP-401 (Part 11 controls, IT service providers, EHR handling, DHTs). | Check for revisions. |
| FDA guidance: Informed Consent | Final, August 2023. | Basis of SOP-301 with 21 CFR 50. | None. |
| 42 CFR Part 2 (substance use disorder records) | HHS final rule February 2024, effective 16 April 2024, compliance date 16 February 2026. | SOP-400 reflects the aligned rule. | Confirm the site's Part 2 consent and notice forms if it receives Part 2 records. |
| HIPAA Privacy Rule to Support Reproductive Health Care Privacy (2024) | Most of the rule was vacated nationwide by the US District Court for the Northern District of Texas on 18 June 2025 (Purl v. HHS). Notice of privacy practices changes tied to Part 2 were left in place. | Library does not rely on the vacated provisions. | Check state reproductive health privacy laws in Appendix A. |
| FDA guidance: Conducting Remote Regulatory Assessments, Questions and Answers | Final, June 2025, replacing the 2024 revised draft. Since the Food and Drug Omnibus Reform Act of 2022, FDA may require records or other information from BIMO-inspected sites in advance of or in lieu of an inspection under FD&C Act section 704(a)(4). Such a request is mandatory; other RRAs are voluntary. | SOP-702 covers mandatory and voluntary RRAs alongside on-site inspections. | Confirm the current version on FDA's guidance page. |
| DEA telemedicine flexibilities for prescribing controlled substances | Temporary DEA and HHS flexibilities extended a fourth time, through 31 December 2026. DEA has not finalized a permanent telemedicine (special registration) rule as of this date. | SOP-313 tells the PI to confirm the DEA rules in force before prescribing or dispensing controlled substances after a telehealth encounter. | Check status before 31 December 2026 and whenever a study involves controlled IP and remote visits. |
| FDA guidance: Investigator Responsibilities: Safety Reporting for Investigational Drugs and Devices | Final, December 2025 (Federal Register document 2025-22869). On 16 December 2025 FDA withdrew the 2009 guidance Adverse Event Reporting to IRBs: Improving Human Subject Protection, which this guidance replaces. | SOP-500, SOP-501, SOP-502, SOP-201, SOP-203 and SOP-800 cite it. Its position: investigators report to the IRB adverse events that are unanticipated problems; individual adverse events generally are not. FDA considers IND safety reports under 21 CFR 312.32(c) to be unanticipated problems, so submitting them to the IRB is an investigator duty (21 CFR 312.66) unless the sponsor submits them on the investigator's behalf and the investigator has confirmation. The IRB's procedures govern format and timing; where an IRB states in writing it will not accept them, the site files that instruction (SOP-502). SOP-201 has the CTA state who submits. | Confirm no SOP or form still cites the 2009 guidance. |
| FDA guidance: Sponsor Responsibilities: Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies | Final, December 2025 (Federal Register document 2025-22870). Replaces the 2012 guidance Safety Reporting Requirements for INDs and BA/BE Studies, withdrawn 16 December 2025. | Cited in SOP-800 for a sponsor-investigator's safety assessment and IND safety reports, and in SOP-501 for sponsor safety reports the site receives. | None for most sites. Sponsor-investigators check SOP-800 section 5.6 against it. |
| FDA guidance: Processes and Practices Applicable to Bioresearch Monitoring Inspections | Final, December 2025 (Federal Register document 2025-23404). | Cited in SOP-702 for how FDA conducts BIMO inspections. | Check for revisions. |
| FDA guidance: Frequently Asked Questions, Statement of Investigator (Form FDA 1572) | Final information sheet guidance May 2010. Revision 1 (May 2021, signature waivers) is a draft. | SOP-101 and SOP-205 follow the 2010 FAQs: a new signed 1572 only when a new PI takes over the study or a new protocol is added; other changes recorded and sent to the sponsor. | Check whether Revision 1 has been finalized. |
| FDA draft guidance: IND Applications Prepared and Submitted by Sponsor-Investigators | Draft, May 2015. Not finalized as of this date. | Cited in SOP-800 as a draft. | Check for a final version if the site runs IITs. |
| Research billing record retention (SOP-202) | No regulation sets a 10-year retention period for a site's research claims records. | SOP-202 uses [DEFAULT: 10 years] as a conservative site choice that covers the False Claims Act limitations period (31 U.S.C. 3731(b)). | Confirm or change the value with counsel at adoption. |
| Common Rule (45 CFR 46, 2018 revision) | Effective January 2019. Single IRB for federally funded cooperative research from January 2020. | Applied only where research is federally funded, or where state law extends it (for example Maryland, Appendix A). | None. |
3. What changed since the 2018 source set
The 10 legacy SOPs this library replaces were written in 2018 to ICH E6(R2). Since then:
- ICH E6(R2) was replaced by E6(R3), with a new structure (principles, Annex 1, appendices), a data governance section, risk-proportionate quality management, and new terms. All section citations in the library use E6(R3).
- The revised Common Rule took effect in January 2019. Its key information requirement is not yet part of FDA's rules, but most central IRBs apply it.
- FDA finalized its Informed Consent guidance (2023), the minimal-risk consent waiver rule (2023), the decentralized trial guidance (2024) and the electronic systems Q&A (2024).
- The investigator safety reporting language in the old SOPs predated FDA's 2010 IND safety reporting rule. The library uses current 21 CFR 312.64(b): the investigator reports any serious adverse event to the sponsor immediately, whether or not considered drug related and including those listed in the protocol or IB, with a causality assessment; only SAEs the protocol defines as study endpoints are reported as the protocol specifies, unless there is evidence of a causal relationship.
- The old unanticipated problem SOP sent all SAEs to the IRB within 24 hours. The library follows the IRB's reportable-event policy and FDA's December 2025 investigator safety reporting guidance, which replaced the 2009 guidance on adverse event reporting to IRBs.
- ISO 14155 moved from the 2011 edition cited in the old SOPs, to 2020, and now to 2026.
- The device Quality System Regulation became the QMSR (February 2026).
- FDA introduced remote regulatory assessments, and FDORA (2022) made records requests under FD&C Act section 704(a)(4) mandatory for BIMO-inspected sites. The old inspection SOP did not cover them and did not state the 15-business-day window FDA allows for a Form FDA 483 response to be considered before further action.
- HIPAA and Part 2 changed as listed in section 2.
- The old consent SOP used one state's treatment-consent rules for research. The library replaces state-specific rules with Appendix A and the IRB's determinations.
4. How to re-check
For each item in section 2, the Quality Lead checks the primary source: the Federal Register and eCFR for rules, FDA's guidance search for guidance, the ICH E6 page for ICH status, and the ISO catalogue for ISO 14155. Record the date checked and the result. If an item's status has changed, open a revision under SOP-100 for the affected SOPs and update this note.
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.