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Working With Us > Forms

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.

• Multicenter
• Site Additions
• Single Site Study
• Additional Forms
• Continuing Review and/or Study Closure
• Safety Reporting
• Additional Resources

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 Initial Study Application
• Multicenter Initial Device Study Application (if applicable)
• Site Information Form (one per site required every two years)
• 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

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• Initial Study Application
• Initial Device Study Application Study (if applicable)
• Site Information Form (one per site required every two years)
• 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

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• Initial Study Application
• Initial Device Study Application Study (if applicable)
• Site Information Form (one per site required every two years)
• 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

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• Request for Partial Waiver of Authorization
• Phone Screen Info Form
• Waiver/Deference of Review Form
• 1572 Equivalent

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• Research Status Report Form - Multicenter/Registry (To be completed by CRO and/or Sponsor)
• Site Status Report Form - Multicenter Investigator/Site (To be completed by investigative site)
• Research Status Report Form - Single Site (To be completed by individual site)
• Final Report - Multicenter/Registry (To be completed by CRO and/or Sponsor)
• Final Report - Single site study and Multicenter site (To be completed by investigative site)

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

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

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