Harmonization guidance by topic

Applies to: all

All HSC guidance is free on the Harmonization page. The current set:

Topic	What it covers
Local considerations	Recommendations for harmonizing local considerations; Institutional Profile and Study-Specific Document templates
Ancillary reviews	Definitions, centralization, timing, responsibilities, implementation checklist
Reportable events	Reporting in investigator-initiated multisite studies
Conflict of interest review processes	Models for COI review and management in sIRB studies
Post-approval auditing in sIRB review	Who audits, how findings are shared
Single IRB continuing review	Continuing review workflows across sites
Review of study personnel	Institution vs. IRB responsibilities for personnel
Institution vs. IRB responsibilities	Which responsibilities stay with the institution when review is ceded
Fees and costing models under the NIH sIRB policy	Fee structures and budgeting

See also - About the Harmonization Steering Committee - Topics in progress