Forms

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Forms

Document NameTypeNumberDownload
Institutional Start-up PackageGuidancepdf
Initial Protocol Submission for Single Site Study ChecklistGuidanceG-106doc
Central Study Submission ChecklistGuidanceG-091doc
Handbook for Quorum Review IRB (Requires an OnQ Portal Account)GuidanceG-043aspx
Safety and Unanticipated Problems PowerpointGuidanceG-042pdf
Submission Illustration for Central StudiesGuidanceBDEV2-022pdf
Continuing Review FlowchartGuidanceG-040pdf
Consent Form Versioning GuidelinesGuidanceG-039doc
Changes to Site Information – GuidelinesGuidanceG-038pdf
Site Information Questionnaire WorkbookGuidanceG-037doc
Safety Information and Unanticipated Problems GuidelinesGuidanceG-036pdf
Consenting Research Participant GuidelinesGuidanceG-035doc
Client Guide to Consent Form Evaluation (Requires an OnQ Portal Account)GuidanceG-034aspx
Recruitment and Participant Study Materials GuidelinesGuidanceG-033pdf
Amendment Submission ChecklistGuidanceG-024doc
Site Submission ChecklistGuidanceG-010doc
Human Subjects Research and Exemption Determination RequestAs IndicatedF-118doc
Observational Registry & Qualified Minimal Risk Site Status ReportRequiredF-117doc
Observational Registry Site Information QuestionnaireRequiredF-101doc
Site Status Report ChecklistGuidanceF-047pdf
Recruitment and Participant Study Materials CoversheetRequiredF-046doc
Request for Waiver or Alteration of HIPAA Authorization RequirementAs IndicatedF-044doc
Waiver or Alteration of Informed Consent Submission FormAs IndicatedF-043doc
Waiver of Documentation of Informed Consent Submission FormAs IndicatedF-042doc
Reopen Request Form for SitesGuidanceF-048doc
Site Status ReportRequiredF-040pdf
Site Information QuestionnaireRequiredF-039doc
Additional Facility Site Information QuestionnaireAs IndicatedF-038doc
Change Request Form for SitesRequiredF-037doc
Single Site Study QuestionnaireRequiredF-036doc
Prospective Protocol Waiver/Exception Request FormRequiredF-035doc
Institutional Authorization AgreementAs IndicatedF-034doc
CV SampleGuidanceF-033doc
CV TemplateGuidanceF-032doc
Conflict of Interest StatementAs IndicatedF-031doc
Compensation TemplateAs IndicatedF-030doc
Change in Principal Investigator FormRequiredF-029doc
Change in Primary Facility FormRequiredF-028doc
California Experimental Subject’s Bill of Rights – SpanishSupplementalF-027doc
California Experimental Subject’s Bill of Rights – EnglishSupplementalF-026doc
Board Meeting ScheduleGuidanceF-025pdf
Unanticipated Problem ReportRequiredF-024doc
Serious Adverse Event ReportRequiredF-022doc
Safety Information and Unanticipated Problem Cover PageRequiredF-021doc
Device Study Submission FormAs IndicatedF-019doc
Protocol Deviation (Major) /Violation ReportRequiredF-018doc
Continuing Review Report for ProtocolsRequiredF-017doc
Institutional Jurisdiction Waiver FormAs IndicatedF-016doc
Federal Funding AddendumAs IndicatedF-015doc
Canadian Extension Central Study QuestionnaireAs IndicatedF-014doc
Central Study QuestionnaireRequiredF-013doc
Central Study Information Change Request FormRecommendedF-012doc
Amendment Submission Cover PageRecommendedF-011doc
Generic Material Change Request FormAs IndicatedF-010doc
Site Status Report Information SheetGuidanceG-244pdf
Generic Material Submission FormAs IndicatedF-009doc
Transfer of Jurisdiction FormAs IndicatedF-056doc
Site Submission SimplifiedGuidanceG-209doc
Continuing Review Report for Protocols – GuidanceGuidanceG-213pdf
Site Status Report for Periodic Review or Closure – GuidanceGuidanceG-059pdf
Annotated Central Study QuestionnaireGuidanceG-135pdf
E-Consent CertificateAs IndicatedF-140doc
E-Consent at Quorum Review – Client GuidanceGuidanceG-215pdf
Defining Human Research (Diagram)GuidanceBDEV3-090pdf
eConsent in Clinical Research Info SheetGuidanceG-228pdf
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