ICH E6(R3) is the international Good Clinical Practice (GCP) guideline for clinical trials, and FDA issued it as final guidance in September 2025. This page is for independent research sites, site networks and provider practices adding clinical research that need a site quality system built to it. Integral Healthcare Solutions (IHS) builds your site's SOP system and audit evidence to ICH E6(R3); your investigators own trial conduct and participant safety.

Last reviewed: October 2026.

What is ICH E6(R3)?

The governing text is the ICH Harmonised Guideline "Guideline for Good Clinical Practice E6(R3)," final version adopted by ICH on 6 January 2025. It consists of the Principles and Annex 1, with Annex 2 published separately. The guideline opens with a definition: "Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the conduct of trials that involve human participants" (ICH E6(R3), Introduction).

Its scope statement reads: "This guideline applies to interventional clinical trials of investigational products that are intended to be submitted to regulatory authorities. The Principles of GCP in this guideline may also be applicable to other interventional clinical trials of investigational products that are not intended to support marketing authorisation applications in accordance with local requirements." It also states that it "encourages a risk-based and proportionate approach to the conduct of a clinical trial" (ICH E6(R3)).

FDA lists the guidance as "E6(R3) Good Clinical Practice (GCP)," final, issued September 2025 under docket FDA-2023-D-1955, and describes it as a guidance that "incorporates flexible, risk-based approaches and embraces innovations in trial design, conduct, and technology" (FDA guidance page).

For a US site running FDA-regulated drug or biologic studies, FDA's regulations also apply. 21 CFR Part 312 sets investigator commitments and records; for example, a sponsor "shall select only investigators qualified by training and experience as appropriate experts to investigate the drug" (21 CFR 312.53(a)). IHS's reading (October 2026): E6(R3) is guidance, and the enforceable requirements for a US drug or biologic site sit in FDA's regulations, such as Part 312. Confirm how that applies to your studies with your regulatory counsel.

Who needs it and what triggers it

The buyer is an independent research site, a site network, or a provider organization adding clinical research to its practice. The usual triggers:

• FDA finalized its E6(R3) guidance in September 2025 (FDA), so SOPs written before then need a check against it.
• The site is taking on "interventional clinical trials of investigational products that are intended to be submitted to regulatory authorities," which is the guideline's core scope (the Principles may also apply to other interventional trials).
• Sponsors are qualifying the site. Sponsors must select investigators "qualified by training and experience" (21 CFR 312.53(a)); training and delegation records are the evidence IHS recommends a site keep to support that.
• An audit or inspection is coming. E6(R3) section 2.3.5 states that "The investigator/institution should permit monitoring and auditing by the sponsor, inspection by the appropriate regulatory authority(ies) and, in accordance with applicable regulatory requirements, review by IRB/IEC(s)."
• The site uses vendors or delegates work to new staff, which brings in the delegation and service-provider sections described below.

How IHS helps

IHS builds the site's quality system through its standard process:

1. A gap assessment of your current SOPs against the E6(R3) principles and annexes and the applicable 21 CFR provisions.
2. Questionnaires on your studies, staff, delegation and vendors, used to build a crosswalk from each guidance expectation to an SOP and a record.
3. Drafting of the site SOP system, delegation-of-authority logs, training records, vendor oversight procedures and audit-readiness procedures, for your principal investigators and site leadership to review and approve.
4. A mock sponsor audit of the assembled system, read the way an auditor would read it.
5. Drafted responses to the mock audit findings, and readiness support as you close them.

What you supply: your current SOPs, the study list, staff CVs and training records, vendor contracts, and investigators who review and adopt every document.

The limit: trial conduct, participant safety and research judgments remain your investigators'. IHS does not monitor trials or make protocol decisions. Sponsor audits and FDA inspections are hosted by your site, and your site, not IHS, deals with the sponsor and FDA.

What to have ready

Each item ties to ICH E6(R3) (final version adopted 6 January 2025, as issued by FDA in September 2025) or to 21 CFR Part 312 as cited.

• A list of current and planned studies, marked against the scope statement: "interventional clinical trials of investigational products that are intended to be submitted to regulatory authorities" (E6(R3), Scope); the guideline adds that its Principles "may also be applicable" to other interventional trials not intended to support marketing authorisation applications.
• Your current SOPs, so they can be read against the guideline's "risk-based and proportionate approach."
• A delegation record. "The investigator should ensure a record is maintained of the persons and parties to whom the investigator has delegated trial-related activities" (E6(R3) 2.3.3).
• A way to show investigator oversight of delegated work. The investigator "retains the ultimate responsibility and should maintain appropriate oversight of the persons or parties undertaking the activities delegated" (E6(R3) 2.3.1).
• Written agreements with vendors. "Agreements made by the investigator/institution with service providers for trial-related activities should be documented" (E6(R3) 2.3.4).
• A procedure for hosting sponsor monitoring and audits, regulatory inspection and IRB/IEC review (E6(R3) 2.3.5).
• A records retention schedule that meets 21 CFR 312.62(c) for drug and biologic studies and any longer period in the sponsor agreement or other applicable requirements: records kept "for a period of 2 years following the date a marketing application is approved" for the indication, or "until 2 years after the investigation is discontinued and FDA is notified" (21 CFR 312.62(c)).
• Investigator CVs and training records that show investigators are "qualified by training and experience as appropriate experts to investigate the drug" (21 CFR 312.53(a)).

The introductory call is the place to go through this list against your site's current documents.

How it compares

IHS's reading (October 2026): an accreditation or certification is a separate decision from building the quality system, and a site that pursues one still needs the SOPs and records that E6(R3) describes. For sites whose studies go through an IRB, see also IRB registration and Federalwide Assurance alignment.

What it costs

E6(R3) and 21 CFR Part 312 describe what a site works to; the pages we reviewed state no fee for compliance. We did not review SASI or IAOCR fees, so check those programs directly. IHS scopes each engagement after a free introductory call.

What this is not

• This page is not legal advice, and IHS's reading of how guidance and regulation interact is not a regulatory determination for your studies.
• IHS does not guarantee the outcome of a sponsor audit, an accreditation decision or an FDA inspection.
• IHS does not monitor trials, act as an investigator, or deal with sponsors or FDA on your site's behalf.

Frequently asked questions

What is Good Clinical Practice under ICH E6(R3)?

ICH E6(R3) defines it this way: "Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the conduct of trials that involve human participants" (ICH E6(R3)). The final version was adopted by ICH on 6 January 2025.

Does ICH E6(R3) apply to my site, and is it legally binding in the US?

The guideline "applies to interventional clinical trials of investigational products that are intended to be submitted to regulatory authorities." It adds: "The Principles of GCP in this guideline may also be applicable to other interventional clinical trials of investigational products that are not intended to support marketing authorisation applications in accordance with local requirements." IHS's reading (October 2026) is that E6(R3) is guidance in the US, and the enforceable requirements for drug and biologic studies sit in FDA regulations such as 21 CFR Part 312. Your regulatory counsel should confirm how that applies to your studies.

When did FDA adopt ICH E6(R3)?

FDA lists "E6(R3) Good Clinical Practice (GCP)" as final guidance issued in September 2025, docket FDA-2023-D-1955 (FDA). ICH had adopted the final guideline on 6 January 2025.

What SOPs does a clinical research site need under GCP?

The set depends on the studies the site runs, since the guideline "encourages a risk-based and proportionate approach to the conduct of a clinical trial." The sections quoted on this page point to procedures for delegation, investigator oversight, service-provider agreements, and hosting monitoring, audits and inspections, plus records retention under 21 CFR 312.62(c). IHS builds the list from a crosswalk of your studies against the guideline.

What does a delegation-of-authority log need to show under E6(R3)?

Section 2.3.3 says "The investigator should ensure a record is maintained of the persons and parties to whom the investigator has delegated trial-related activities" and that documentation "should be proportionate to the significance of the trial-related activities." Section 2.3.1 adds that the investigator "retains the ultimate responsibility" and should oversee the delegated work.

How should an investigator oversee vendors and service providers under E6(R3)?

Section 2.3.4 states that "Agreements made by the investigator/institution with service providers for trial-related activities should be documented." The oversight duty in section 2.3.1 covers "persons or parties" undertaking delegated activities, so the site needs both the agreement and a record of oversight.

How long must a site keep records for an FDA-regulated drug or biologic study?

Under 21 CFR 312.62(c), an investigator keeps required records "for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated," or, if no application is filed or it is not approved, "until 2 years after the investigation is discontinued and FDA is notified" (eCFR). That is the Part 312 minimum for investigational drug studies. E6(R3) section 2.12.12 says the investigator/institution should retain essential records "for the required retention period in accordance with applicable regulatory requirements," so device studies, sponsor agreements and other rules may set a different or longer period; confirm the period with the sponsor's contract and your counsel.

How do I prepare my site for a sponsor audit or an FDA inspection?

E6(R3) section 2.3.5 expects the investigator or institution to "permit monitoring and auditing by the sponsor, inspection by the appropriate regulatory authority(ies)" and IRB/IEC review. Preparation means the delegation, training, vendor and retention records above are current and retrievable. IHS runs a mock sponsor audit against them; your site hosts the real audit or inspection.

Should an independent research site pursue site accreditation (SASI, GCSA) or just build a GCP quality system?

They are different things. SASI Clinical Research Site Accreditation and IAOCR's GCSA certification are external programs with their own assessment steps, while an E6(R3) quality system is what the site runs day to day and what sponsors audit. The choice depends on what your sponsors and your own strategy call for; IHS builds the quality system either way and does not grant or predict any accreditation.