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Dedicated to ensuring the rights and welfare of study participants, Aspire IRB provides sites and sponsors with cost-effective solutions that (1) empower ethical research, and (2) streamline IRB documentation and submission. When you partner with us, you'll experience firsthand the commitment, skill, accuracy and responsiveness of our expert team.

Read on to learn more about your role as a site or sponsor, and to discover how our knowledgeable staff delivers accuracy, professionalism and reliability while safeguarding the well-being of each research participant.

Multicenter: These forms are to be used by the CRO and/or Sponsor for the submission of a multicenter study and should include the protocol, IB and/or device description and electronic version of the Informed Consent document.

  • Multicenter Initial Study Application (hyperlink to form Initial Study Application Sponsor/CRO –Multicenter Study)
  • Multicenter Initial Device Study Application (if applicable) (hyperlink to form Initial Device Study Application (Sponsor/CRO - Multicenter Study)
  • Site Information Form (one per site required every two years) (hyperlink to Site Info Form)
  • Protocol
  • Investigator's Brochure(s)
  • Package Insert (if applicable)
  • Device Description (if applicable)
  • Informed Consent Document(s) (electronic version)
  • Form FDA 1572 (or 1572 Equivalent, provided by Aspire IRB, if applicable)
  • Curriculum Vitae for PI (signed and dated within 2 years)
  • Current Medical License for PI only (if applicable)
  • Additional information may be requested on a case-by-case basis

Site Additions: These forms are to be used by the PI/Site that will be conducting a multicenter research study.

  • Initial Study Application (hyperlink to Initial Study Application (Investigator-Multicenter Study))
  • Initial Device Study Application Study (if applicable) hyperlink to Initial Device Study Application (Investigator - Multicenter Study)
  • Site Information Form (one per site required every two years)
    (hyperlink to Site Info Form)
  • Form FDA 1572 (or 1572 Equivalent, provided by Aspire IRB, if applicable)
  • Curriculum Vitae for PI (signed and dated within 2 years)
  • Current Medical License for PI only (if applicable)
  • Additional information may be requested on a case by case basis

Single Site Study: These forms are to be used by the PI/Site that will be conducting a single site research study.

  • Initial Study Application hyperlink to Initial Study Application (Single Site Study)
  • Initial Device Study Application Study (if applicable) hyperlink to Initial Device Study Application (Sponsor/CRO - Multicenter Study)
  • Site Information Form (one per site required every two years) hyperlink to Site Info Form
  • Protocol
  • Investigator's Brochure(s)
  • Package Insert (if applicable)
  • Device Description (if applicable)
  • Informed Consent Document(s) (electronic version)
  • Form FDA 1572 (or 1572 Equivalent, provided by Aspire IRB, if applicable)
  • Curriculum Vitae for PI (signed and dated within 2 years)
  • Current Medical License for PI only (if applicable)
  • Additional information may be requested on a case by case basis

Additional Forms: These are specialized forms to be completed upon request of the IRB or in the event you require the following services.

  • Request for Partial Waiver of Authorization
  • Hyperlink to form Request for Partial Waiver of Authorization
  • Phone Screen Info Form hyperlink to phone info screen form
  • Waiver/Deference of Review Form hyperlink to Waiver / Deference of Review Form
  • 1572 Equivalent hyperlink to 1572 equivalent

Continuing Review and/or Study Closure: These forms are to be completed for study continuance or in the event you wish to close your study.

  • Research Status Report Form – Multicenter/Registry
    (To be completed by CRO and/or Sponsor) hyperlink to form Research Status Report Form (Sponsor/CRO - Multicenter/Registry Study)
  • Site Status Report Form – Multicenter Investigator/Site
    (To be completed by investigative site)
    hyperlink to Site Status report Form
  • Research Status Report Form – Single Site
    hyperlink to Research Status Report Form
    (To be completed by individual site)
  • Final Report – Multicenter/Registry
    (To be completed by CRO and/or Sponsor)
    Hyperlink to Final Report Form-Multicenter
  • Final Report – Single site study and Multicenter site
    (To be completed by investigative site)
    Hyperlink to Final Report Form-Investigator

Safety Reporting: These forms are to be completed for the reporting of Unanticipated Problems, Serious Events and Serious Protocol Deviations/Violations.

  • Significant Protocol Deviation/Violation Report Form
  • Unanticipated Problem Involving Risk to Subject or Others
  • Unanticipated Adverse Device Effect Reporting Form

 

  • Aspire IRB Investigator Manual
    hyperlink to Investigator Manual
  • Experimental Subject's Bill of Rights (California sites)
    hyperlink to Experimental Bill of rights
  • Experimental Subject's Bill of Rights/Spanish (California sites)
    hyperlink to Experimental Bill of rights-Spanish