Bridging the Gap Between Human Research Participants, Investigators & Research Sponsors.

Print Page

Submission Guidelines

The Principal Investigator or Sponsor/CRO will submit to Opus IRB all forms electronically through the OpusView® or via email prior to the scheduled IRB Meeting.

NOTE: All IRB fees are expected promptly for submissions to Opus IRB when required.

Submissions to OPUS IRB should be sent to the following address:

Opus Institutional Review Board
1175 Grimes Bridge Road, Suite 300
Roswell, GA 30075 USA

Phone: 1-877-346-8420 Fax: 678-736-7949 Email: info@opusirb.com

Or, documents may be uploaded to your OpusView® account.

  1. New Study Submissions (no incomplete submissions will be added to the agenda until all items are received):
    • Investigator/Site Questionnaire
    • Submission Letter requesting IRB Review
    • For DEVICE Studies: A letter from the FDA approving the Investigational Device Exemption (IDE) or clearance; or a Pre-Market Approval (PMA) letter, supplement letter or amendment letter and a Risk Assessment Report from the Sponsor
    • For PEDIATRIC Studies, a Letter from the Sponsor classifying the research as described in 45 CFR 405, 406 or 407 or the FDA Interim Ruling on pediatric studies
    • Study Protocol (draft protocols accepted)
    • Protocol Synopsis or Summary
    • Protocol Title/Protocol Signature Page
    • Site Specific Information for Consent Form or for HHS supported multi-center clinical trials, the HHS-approved sample consent form with site- specific information (via upload or email); consent form preparation for sites by OPUS IRB is available upon request
    • Subject surveys or questionnaires (if applicable)
    • Any relevant grant application(s)
    • Curriculum Vitae of Principal Investigator and all Sub-Investigators (include a list of previous clinical research experience and publications).
    • Copy of current medical license with expiration date (wallet card acceptable) for Principal Investigator and all Sub-Investigators
    • Copy of Principal Investigator’s and all Sub-investigator’s NIH “Protecting Human Research Participants" certification (must be current within 3 years)
    • Copy of FDA Form 1572 (if applicable)
    • Copy of all proposed advertisement(s)/Recruitment Materials
    • Investigator’s Drug Brochure and/or Package Insert(s)
    • Relevant background investigations, including reports of pertinent animal and human studies conducted with the test article or procedure
    • Device Manual of Operations (if applicable)
    • Completed Financial Disclosure / Certification Form (for all investigators)
    • Completed HIPAA Compliance Form
    • Information regarding the submission of this study to another IRB along with any reports, correspondence and determinations of the other IRB(s)
  2. New Investigator Submissions (for protocols under OPUS IRB review)
    • Protocol Title/Signature Page
    • Site Specific Information for Consent Form
    • Completed Investigator Site Questionnaire
    • Completed Financial Disclosure/Certification Form (for PI only)
    • Curriculum Vitae of Principal Investigator (include list of previous clinical research experience and publications)
    • Curriculum Vitae of Sub-Investigators
    • Copy of FDA Form 1572 (if applicable)
    • Copy of all proposed Advertisements/Recruitment Materials
  3. Sub Studies
    • Submission Letter
    • Copy of Sub study Protocol
    • Copy of Sub study Consent with Site Specific Information
    • Copy of any questionnaires or surveys to be used with subjects
    • Copy of any Advertisements/Recruitment Materials
    • Specific information regarding genetic materials
    • Any other materials for IRB review
  4. Amendments to the Protocol; Amendments to the Investigator’s Brochure; Addition of another arm or treatment group to the protocol (submit items that are applicable)
    • Submission Letter
    • Copy of Sub study Protocol
    • Copy of Sub study Consent with Site Specific Information
    • Copy of Summary of Changes or tracked version of protocol showing changes
    • For Device Studies, copy of FDA IDE letter approving amendment
    • For Device Studies, a copy of the FDA Letter with the HFCA billing code (Category A, Category B)
    • Copy of any questionnaires or surveys to be used with subjects
    • Copy of any Advertisements/Recruitment Materials
    • Any other materials for IRB review.
  5. Continuing Review Reports (must be received prior to expiration of IRB approval and IRB Agenda due date).
    • Completed continuing review report signed by PI
    • Copy of current informed consent
    • Required attachments
  6. Advertisement(s)
    • Cover letter requesting IRB review
    • Copy of Advertisement
  7. Adverse Event (from your site)
    • Original of the adverse event report form signed by the PI
    • Copy of the risk section of the informed consent document
  8. Protocol Deviation Report
    • Original deviation report form signed by the PI
  9. Other reports as received by the site
    • Copy of all Monitoring Letters and attached correspondence
    • Copy of all DSMB Reports, IND Safety Reports, MedWatch Reports, Safety Reports, interim or annual reports from the Sponsor or other reports received from the Sponsor for the study
  10. FDA or OHRP Audit
    • Copy of FDA NAI letter, FDA 483, Warning Letter or other regulatory letter
    • Associated correspondence from site and regulatory agency
  11. HIPAA Waiver
    • Cover letter requesting IRB Waiver
    • Attachments
  12. HIPAA Informed Consent Modification
    • Cover letter requesting IRB review
    • Informed consent