Forms for Post-Approval Requests and Reporting

The forms on this page are for use with proposals that already have been approved by the IRB. If you are preparing an initial submission, please visit the Forms for Initial Submissions page.

Forms for Post-Approval Requests

Step 1: As you prepare your documenation, review these checklists to ensure you provide a complete post-approval request. The IRB will not process your request until it meets these standards.
Proposal Writing: Guidance for Investigators (updated 01/22/2013) For modification requests, use this list of questions to ensure that you have addressed all relevant issues in you modified proposal prior to submitting it for review.
Post-Approval Submission Checklist (updated 06/04/2013) Use this checklist to ensure that you have completed all required steps and documentation prior to submitting your continuing review, modification, or project closure request to the IRB.

Step 1: As you prepare your documenation, review these checklists to ensure you provide a complete post-approval request. The IRB will not process your request until it meets these standards.

Proposal Writing: Guidance for Investigators (updated 01/22/2013)

For modification requests, use this list of questions to ensure that you have addressed all relevant issues in you modified proposal prior to submitting it for review.

Post-Approval Submission Checklist (updated 06/04/2013)

Use this checklist to ensure that you have completed all required steps and documentation prior to submitting your continuing review, modification, or project closure request to the IRB.

Step 2: Use this template to organize your post-approval request before sending it to the IRB.
Post-Approval Formatting Template (updated 06/04/2013)

Step 3: Complete this form.
Post-Approval Requests (updated 06/04/2013) Use this form to comply with continuing review requirements, to submit a modification to an approved protocol, or to let the IRB know that your project is closed.

Step 3: Complete this form.

Post-Approval Requests (updated 06/04/2013)

Use this form to comply with continuing review requirements, to submit a modification to an approved protocol, or to let the IRB know that your project is closed.

Step 4: Complete the supplementary forms that are applicable to your post-approval request.
Statement of Assurance (updated 06/04/2013) This form is required for all submissions. If, per your proposed modifications, additional supplementary forms are necessary, please visit the Forms for Initial Submissions page and complete the necessary documentation.

Step 4: Complete the supplementary forms that are applicable to your post-approval request.

Statement of Assurance (updated 06/04/2013)

This form is required for all submissions.

If, per your proposed modifications, additional supplementary forms are necessary, please visit the Forms for Initial Submissions page and complete the necessary documentation.

Step 5: Collect all study documentation.
Be sure to submit (and, as necessary, make modifications to) the final, approved version of the study documentation that was part of your initial submission. For continuing review and modification requests, any proposed changes to your study must be noted in your Post-Approval Requests form and modified and highlighted in your study documentation. This includes the addition and/or removal of study personnel, changes made to study dates and/or timelines, and all changes made to the study protocol and participant documents. Be sure to highlight all proposed changes when in Microsoft Word format. The PDF format should be provided as a clean copy. For project closures, you may forego the submission of study documentation. Instead, provide any final reports, theses, presentations, and/or articles that were derived from your research.

Step 5: Collect all study documentation.

Be sure to submit (and, as necessary, make modifications to) the final, approved version of the study documentation that was part of your initial submission.

For continuing review and modification requests, any proposed changes to your study must be noted in your Post-Approval Requests form and modified and highlighted in your study documentation. This includes the addition and/or removal of study personnel, changes made to study dates and/or timelines, and all changes made to the study protocol and participant documents. Be sure to highlight all proposed changes when in Microsoft Word format. The PDF format should be provided as a clean copy.

For project closures, you may forego the submission of study documentation. Instead, provide any final reports, theses, presentations, and/or articles that were derived from your research.

Forms for Reporting

Authorization Agreements
Authorization Agreement (updated 01/22/2013) Use this form to establish an agreement between the Pacific University IRB and another IRB with an OHRP-approved FWA. This form can be used to grant oversight of a research study to Pacific or to to another IRB. In either case, you must submit all paperwork associated with the study to Pacific so that accurate records may be kept.

Authorization Agreements

Authorization Agreement (updated 01/22/2013)

Use this form to establish an agreement between the Pacific University IRB and another IRB with an OHRP-approved FWA. This form can be used to grant oversight of a research study to Pacific or to to another IRB. In either case, you must submit all paperwork associated with the study to Pacific so that accurate records may be kept.

Incident Reports: Adverse Events, Issues of Noncompliance, and Unanticipated Problems
Incident Reports (updated 06/04/2013) Use this form to submit a report to the IRB about an adverse event, an issue of noncompliance, or an unanticipated problem that has occurred during the course of your research and that negatively affects the human participants. Such reports should be made immediately, but no later than seven (7) calendar days after you become aware of the incident.

Incident Reports: Adverse Events, Issues of Noncompliance, and Unanticipated Problems

Incident Reports (updated 06/04/2013)

Use this form to submit a report to the IRB about an adverse event, an issue of noncompliance, or an unanticipated problem that has occurred during the course of your research and that negatively affects the human participants. Such reports should be made immediately, but no later than seven (7) calendar days after you become aware of the incident.

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Forms for Post-Approval Requests and Reporting