Standards Library
Browsable reference of the regulations AccrediSense evaluates against.
ICH E6(R3) Good Clinical Practice
Effective EU Jul 2025
| Section | Requirement | Stakeholders | Delegable | Evidence expected |
|---|---|---|---|---|
| §3.2 | Informed Consent | SiteSponsor | No | Signed ICF, version-controlled |
| §4.9 | Investigator Records | Site | No | Delegation log, CVs, licenses |
| §5.18 | Monitoring | CROSponsor | Yes | Monitoring visit reports |
| §8.0 | Essential Documents / TMF | SponsorCROSite | Yes | TMF index, completeness rpt |
21 CFR Part 11 Electronic Records / Signatures
FDA
| Section | Requirement | Stakeholders | Delegable | Evidence expected |
|---|---|---|---|---|
| §11.10 | Controls for Closed Systems | SponsorCRO | Yes | System validation package |
| §11.50 | Signature Manifestations | SponsorCROSite | No | E-signature meaning captured |
21 CFR Part 312 IND Application
FDA
| Section | Requirement | Stakeholders | Delegable | Evidence expected |
|---|---|---|---|---|
| §312.32 | IND Safety Reports (SUSAR) | Sponsor | No | Timely SUSAR submission log |
| §312.33 | Annual Reports (DSUR) | Sponsor | No | DSUR filed within 60 days |
EU CTR 536/2014 EU Clinical Trials Regulation
In force
| Section | Requirement | Stakeholders | Delegable | Evidence expected |
|---|---|---|---|---|
| §Art. 41 | Serious Breach Notification | Sponsor | No | 7-day breach notification |
| §Art. 37 | End of Trial Reporting | Sponsor | No | CTIS end-of-trial report |
21 CFR Part 50 Protection of Human Subjects
FDA
| Section | Requirement | Stakeholders | Delegable | Evidence expected |
|---|---|---|---|---|
| §50.25 | Elements of Informed Consent | SiteSponsor | No | ICF meets all required elements |
| §50.27 | Documentation of Consent | Site | No | Signed & dated by subject |
MHRA GCP UK MHRA GCP Guide
2024
| Section | Requirement | Stakeholders | Delegable | Evidence expected |
|---|---|---|---|---|
| §6.4 | Investigator Site File | Site | No | ISF matches MHRA expectations |