HOW-TO INSTRUCTIONS

Important Note: Prior to beginning this process, it is important to make sure you have already accessed our website to utilize the latest forms and templates for drafting your Protocol Narrative or Existing (Secondary) Data Protocol, Informed Consent and/or Assent forms, as well as any supporting documents, such as the Faculty Supervisor Statement, Letter of Agreement(s), survey/interview/intervention materials, recruitment materials, mental health resources, etc. All applicable documentation must be completed and uploaded in your PACS submission. Additionally, please make sure you, your Faculty Advisor (if applicable), and all members of your study team are registered in PACS and have completed the required CITI training (Group 1 Biomedical Research or Group 2 Social and Behavioral Research).

1. Log into PACS at the following link.
2. Select the IRB tab at the top, then select the Create New Study tab below on the left side of the screen.
3. Complete the PACS smart form, answering all questions and uploading documents in the appropriate locations. Select +Add to upload documents. For example, only upload the completed Protocol Narrative under #8 Attach the protocol section of the smart form. Supplemental documents such as the consent forms, etc. will be uploaded under Local Site Documents. See below for details regarding where to load study documents.

4. Add all study team members under Local Study Team Members and select their corresponding role in the research study. For student researchers, please make sure you add your Faculty Advisor here as well. (you will not be able to add team members unless they have registered with PACS)
   

5. The CITI training section in the PACS smart form is informational and does not always populate the CITI training for internal study team members. The IRB will verify training for all team members, but this should be completed before submission. Please do not upload CITI certifications for internal team members.

6. Once all relevant documents are uploaded, study team members have been added, and the smart form completely filled out, select Save and Continue to save and return back to the pre-submission page.
   

7. You will be directed back to the pre-submission page where you will need to select Submit on the left side of the screen in order for your study to be submitted to the IRB for processing.
   

1. Log into PACS at the following link.
2. Select the IRB tab at the top, then select the Active tab below to find your active IRB submission(s). Select the study that requires a modification.
3. On the left side of the screen, under Next Steps, select Create Modification/CR to initiate the modification.
4. On the next screen (see below), select Modification / Update.
5. Next, indicate the Modification scope by selecting, Study team member information (to add/remove study team members) and/or Other parts of the study (to update study materials).
6. Next, complete the Modification Information and make sure to describe the amendments being made under Summarize the modifications. If adding and/or removing study team members, you must list the names of the individuals being added and/or removed in this section.
7. Ensure that all relevant study documents are updated and uploaded in the appropriate areas in PACS. For example, the updated Protocol Narrative should be labeled as “Protocol Narrative Modified [Date]”, and then select the + Add option under Attach the protocol to upload the updated document. Please follow the same logic for updating the informed consent, recruitment materials, and other attachments (survey measures, etc.). Do not delete the original/previously approved documents. 
8. Once all relevant/modified documents are updated/uploaded, and study team members have been added and/or removed in the smart form, select Save and Continue to save and return back to the pre-submission page.
9. You will be directed back to the pre-submission page where you will need to select Submit on the left-hand side of the screen in order for your modification to be submitted to the IRB for processing. 

1. Log into PACS at the following link.
2. Select the IRB tab at the top, then select the Active tab below to find your active IRB submission(s). Select the study that requires Continuing Review (CR).
   

   NOTE: Before submitting your CR in PACS, please review your study materials and study team members to determine if a CR and Modification are necessary for submission. This may include updating your Informed Consent, Protocol Narrative, or adding or removing study team members. If so, the CR and Modification can and should be submitted at the same time.

3. On the left side of the screen, under Next Steps, select Create Modification/CR to initiate the CR.
4. On the next screen (see below), select Continuing Review or Modification and Continuing Review.
5. Next, go through and complete the smart form by filling in how many participants were enrolled, the research milestones, and indicate if there have been any unanticipated events/problems/complaints/withdrawals. If there were no issues of this nature, all items should be checked appropriately under section #4 in the smart form. If there were issues outlined in the checklist, please contact the IRB Office before completing this form.

   NOTE: If the first 4 boxes are selected under #2 Research Milestones, the study is eligible/will be submitted for closure.

6. If you are submitting a modification as part of this CR, briefly describe what will be modified under Summarize Modifications. This should include the names of individuals being added and/or removed from the study team, as well as a brief summary about any changes to study procedures, materials, etc. Please then update the study team
   and documents in the smart form. For more information regarding modifications, please contact the IRB office.
7. Once you reach the final page, select Save and Continue to save the information entered into the smart form.
8. You will be directed back to the pre-submission page where you will need to select Submit on the left-hand side of the screen in order for your CR to be submitted to the IRB for processing.

1. Log into PACS at the following link.
2. Select the IRB tab at the top, then select the Active tab below to find your active IRB submission(s). Select the study you wish to close.
3. . On the left side of the screen, under Next Steps, select Create Modification/CR to initiate the closure.
4. On the next screen (see below), select Continuing Review in order to populate the closure options.
5. Next, go through and complete the smart form by filling in how many participants were enrolled, etc.
6. Under section #2, Research Milestones, you must check the first 4 options or PACS will not initiate the study closure and this will be sent back to you for revision until the correct options are selected.
7. Complete the remainder of the smart form. Please note that supporting documents are not required if there were no unanticipated events/problems/complaints/withdrawals. If there were no issues of this nature, all items should be checked appropriately under section #4 in the smart form. If there were issues outlined in the checklist, please contact the IRB Office before completing this form.
8. Once you reach the final page, select Save and Continue to save the information entered into the smart form.
9. You will be directed back to the pre-submission page where you will need to select Submit on the left-hand side of the screen in order for your closure to be submitted to the IRB for processing.