Forms and Templates

INSTRUCTIONS Zipline for Staff

Compiled instructions for all staff activities in Zipline.

Change Notes

2.1.24

• Revise INSTRUCTIONS Site Closure
• New section INSTRUCTIONS: Submit Report of New Information (RNI) Pre-Review for External IRB RNI

1.4.24
Update to allow the use of the prepare and send letter function in Zipline for external modifications

11.2.2023

• Added clarification that NHS, NR, & NE determinations cannot be closed in the system but exemptions can be closed
• Added assign coordinator step to INSTRUCTIONS: Submit RNI Pre-Review for Single Patient Expanded Access

9.14.2023

• Added a note that a multi-site application may be assigned to an internal team, and the relying sites (pSites) to Team S
• Revised reliance processes: Prepare Letter Activity for External studies, Disallow edits while in pending sIRB Review state, Disallow researchers to finalize updates
• Added section INSTRUCTIONS: External Consent Audit
• Revised CT.gov Data Entry Steps
• Updated SmartForm screenshots for Add Funding Sources and Study Scope Q4

7.27.2023

• Corrected hyperlinks within document
• Minor update to INSTRUCTIONS: Record sIRB Decision section

6.1.2023

• Updated SmartForm screenshots with additional Drugs categorization
• Action plan is required on the Review Required Actions activity for a RNI

3.30.2023

• Fixed numbering order of steps on pg. 19
• Minor updates to Management Review of IRB Noncompliance steps on pg. 66

9.29.2022

• Simplified administrative closure instructions
• Updated SmartForm screenshots to reflect changes with 8/29/22 Zipline patch

8.25.2022

• Revised to add administrative closure procedures for lapsed approval

8.4.2022

• Updated RNI Sections
• Staff discard requests now go to hsdinfo

6.30.2022

• Updated to reflect new processes for site review and site modification review.

2.15.2022

• Removed special note about adding the IRB meeting date by hand to the deferral letter, as it is now automatically populated with the IRB meeting date.
• Added a note about the need to correct the minutes if one uploads a revision, and then clicks Cancel.
• Updated the Study Scope page snap shot with updated question number six.

12.28.2021
Clarify that the meeting date will have to be manually entered to the deferral letter if the effective date is left blank in Committee Review.

12.07.2021

• Update that faculty advisor review is only required for students and residents
• Remove reference to updating Pre-Review for data migration from 9.0 upgrade
• Clarify review order for concurrent follow-ons
• Clarify when Pre-Review can be updated for Continuing Reviews
• Add note that risk level for Continuing Reviews should be the risk level of the overall study
• Clarify appropriate determination when re-submitting review to correct an error
• Remove references to conversions
• Update to reflect that effective date can be left blank for deferrals
• Update location of SUPPLEMENT IRB-related Report of New Information
• Clarify that Review Required Action activity should not be completed if action needs to be reviewed by the IRB
• Minor wording updates
• Screenshot updates

10.28.2021
Clarify instructions for IRB SNC and CNC

9.30.2021
Update to CT.gov data entry

8.30.2021

• Clarify that inability to modify determinations only applies to 2018 Requirement pre-9.0 upgrade determinations
• Clarify that ‘Cancel’ should be clicked if Staff Data Entry is opened and updates do not need to be made
• Clarify that a person must first be assigned as IRB Coordinator for a study before they can Administratively Close a study

4.29.2021

• Add instructions for requesting that an item be discarded
• Add ‘During Modification Review’ headers
• Add clarification that if an exempt category no longer applies, it should not be selected in designated review for the modification
• Add clarification that the risk level selected in designated review should reflect the risk level of the overall study, not the risk level of the modification
• Add instructions to Post-Review section that the exempt letter should be revised to state the study “continues to qualify” for exempt status for modifications
• Update screenshots to reflect SmartForm revisions

1.21.2021

• Removed Youth Programs ancillary review steps
• Added instructions for exempt modifications
• Revised instructions for concurrent follow-on submissions
• Removed participating sites from Upload Shared Regulatory Documents instructions
• Added instructions for site closure
• Added ClinicialTrials.gov instructions
• Minor clarifications and formatting revisions

10.16.2020
Clarified RNI process for IRB non-compliance
Added steps for UW Office for Youth Programs ancillary review

8.27.2020

Updates to reflect fixes from the 8.27 patch.

6.25.2020

Added instructions for processing Emergency Use in Zipline.

4.24.2020

Added instructions for processing DOHRs in Zipline.

3.17.2020

Small updates to reflect fixes from the 3.17 patch.

2.21.2020

• Clarified that determinations made prior to January 9.0 upgrade cannot be modified
• Clarified that external studies created before the January 9.0 upgrade that need to be changed to the internal review path must be copied and discarded
• Other minor updates

1.7.2020

Updated instructions due to Zipline Upgrade

6.29.2019

Removed all references to Confidentiality Agreements and to state law RCW 42.48; added instructions on lifting suspensions

6.7.2019

Updated the conversion quick steps guide

4.12.2019

Updated screenshots of funding SmartForm, updated instructions on Administrative Withdrawal

1.28.2019

Removed instructions on transitioning studies from the Original Common Rule to the Revised Common Rule

12.28.2018

Added new instructions on transitioning studies from the Original Common Rule to the Revised Common Rule

11.30.2018

Added new instructions related to the Revised Common Rule, revised instructions to indicate that the administrative withdrawal activity should not be used for follow-on submissions

8.24.2018

REVISED:

Incoming Items-New Studies, Assign IRB Coordinator, Assign to Team, Assign Designated Reviewer, Request Clarification, View Changes to a Study, Manage Ancillary Reviews (Staff Version), Edit Pre-Review, Administrative Withdrawal , Submit Not Research Determinations, Submit Not Human Subjects Determinations, Submit Not Engaged Determinations, Submit Exempt Determinations, Submit Expedited Review, Submit Pre-Review for Full Board Items, Resubmit Review to Correct an Error, Changing IRB Review to NR, NHS, NE, Changing Expedited to Exempt or Exempt to Expedited, Review Required Modifications, Submit Committee Review, Submit Not Non-Compliance Determination, Submit Minor Non-Compliance Determination, Submit RNI Designated Review, Submit RNI Pre-Review for Full Board, Confirm External IRB, External IRB Staff Data Entry, Study Closure, Administrative Closure, QS: IRB Coordinator Steps for Full Board Items, QS: IRB Meetings

NEW:

Appendix II: New Study SmartForm, Reassign Primary Contact for RNI, Accept External IRB Updates

RETIRED:

Update External IRB Status

3.30.2018

REVISED:

• INSTRUCTIONS: Prepare Meeting Minutes- added additional detail about completing the minutes for RNI
• INSTRUCTIONS: Add Related Submission, INSTRUCTIONS: Submit Not Non-Compliance Determination, INSTRUCTIONS: Submit Minor Non-Compliance Determination, INSTRUCTIONS: Designated Review of RNI, INSTRUCTIONS: Submit RNI Designated Review, INSTRUCTIONS: Submit RNI Pre-Review for Full Board, INSTRUCTIONS: Submit RNI Committee Review- noted that the study team of related submissions can see RNI review information and that confidential information should be documented in RNI as a private comment

1.12.2018

Revised:

• Incoming Items- New Studies– external IRB studies are now assigned to the “Reliance” team and not directly to a reliance administrator
• Submit Exempt Determination– staff no longer complete question about subject populations, determinations, and waivers
• Submit Expedited Review– staff no longer complete question about subject populations, determinations, and waivers; added changing PI additional instructions
• Submit Pre-Review for Full Board items– staff no longer complete question about subject populations, determinations, and waivers; added changing PI additional instructions
• Submit Report of New Information– reflects changes to RNI SmartForm
• Submit RNI Committee Review– added note that only the primary responsible party is able to submit the action response
• Study Closure– for full board studies that were never reviewed under an expedited category, select “Expedited” as the review level and “Other” as the category; changed instructions to indicate that the last day of approval period should just be left as the date that is auto-generated in Submit Designated Review
• Quick Steps: Finishing an Expedited Review or Determination
• Quick Steps: Finishing a Conversion Application
• Quick Steps: IRB Coordinator Steps for Full Board Items
• Other minor revisions

10.27.2017

• New:
  • Administrative Closure: Added instructions on closing an approved study without a continuing review report submission
• Revised:
  • View Changes to a Study: Now includes link to Microsoft instructions on how to Compare Documents
  • Submit Expedited Review, Submit Pre-Review for Full Board Items: Updated to indicate that Pre-Review regulatory oversight selections should not be unchecked during review of modifications
  • Resubmit Review to Correct an Error: Updated to include additional detail for modifications and continuing review
  • Not Human Subjects Modifications for IRB Reviewed Studies (No Change in Study Review Level): Updated to indicate that only GDS modifications need review and that in other situations the modification can just be discarded and needed documentation uploaded for the researcher as a shared regulatory document
  • Review Required Modifications: Added more detail about when staff are unable to verify modifications and need to return the application to the study team
  • Finalize Documents: Noted that exceptions may be made to what documents are finalized for IRB approval and added what should be finalized for conversions
  • Staff Data Entry: Updated to indicate that consultant emails that apply to the study as a whole should be uploaded here
  • Prepare and Send the Meeting Agenda: Updated to reflect that TOLs are sending the agendas to themselves and then forwarding to committee members
  • Prepare Meeting Minutes: Added additional detail about revisions that should be made to the minutes template
  • Designated Review of Reports of New Information: Consolidated instructions for review staff assigned as the designated reviewer of a RNI
  • Submit Not Non-Compliance Determination: Now includes instructions for “Refer Not Non-Compliance RNI,” which have been deleted to simplify
  • Submit Minor Non-Compliance Determination, Submit RNI Pre-Review for Full Board: Updated to include information on attaching consultation documentation
  • Submit RNI Designated Review: Now addresses all situations where the compliance administrator is submitting the designated review, not just minor non-compliance, removal of the Master Checklist, added attaching any consults
  • Submit RNI Committee Review: Updated to include information on attaching consultation documentation, removal of the Master Checklist
  • Review Required Actions: Revised to clarify Compliance Administrator’s responsibilities
  • External IRB Staff Data Entry: Updated to add that Confidentiality Agreements should be uploaded as shared regulatory documents
  • Quick Steps: Document Naming Conventions: Noted that exceptions may be made to the naming convention
  • Quick Steps: Finishing an Initial Expedited Review or Determination, Finishing an Expedited Modification or Continuing Review: Updated to indicate that Pre-Review regulatory oversight selections should not be unchecked during review of modifications, Added Shared Regulatory Documents step
  • Minor Changes:
    • Incoming Items- New Studies
    • Assign IRB Coordinator
    • Assign Designated Reviewer
    • Administrative Withdrawal
    • Submit Not Research Determinations
    • Submit Not Human Subjects Determinations
    • Submit Not Engaged Determinations
    • Submit Exempt Determinations
    • Changing Not Research, Not Human Subjects, or Not Engaged Determinations to IRB Review
    • Changing an Expedited Study to Exempt or Changing an Exempt Study to Expedited
    • Upload Shared Regulatory Documents
    • Prepare and Send the Determination Letter
    • Submit Committee Review
    • Submit Report of New Information (RNI)
    • Finishing a Conversion Application
• Deleted:
  • Refer Not Non-Compliance RNI: Now combined with Submit Not Non-Compliance Determination
  • Review the Correcting Action Plan for Minor Non-Compliance and Submit RNI Designated Review for Not Non-Compliance Requiring Additional Review: Now combined into Designated Review of RNI
  • Quick Steps: Zipline Steps for Minor Non-Compliance RNI and Quick Steps: Not Non-Compliance RNI that Requires Additional Review: No longer needed

Updated external document links – 05.05.2017

04.14.2017:

• Change: Need for instructions on how to change a determination for a Zipline study at the time of modification. Note that NR/NHS/NE determinations cannot be changed to a different determination due to our Zipline customization.
  • Added: New Section to staff instructions- Changing Determinations at Time of Modification
    • INSTRUCTIONS: Changing Not Research/Not Human Subjects/Not Engaged Determinations to IRB Review
    • INSTRUCTIONS: Changing IRB Review to Not Research/Not Human Subjects/Not Engaged Determination
    • INSTRUCTIONS: Not Human Subjects Modifications for IRB Reviewed Studies (No Change in Review Level)
    • INSTRUCTIONS: Changing an Expedited Study to Exempt or Changing an Exempt Study to Expedited
  • Revised: Minor revisions to reference new instructions for changing determinations at time of mod
    • INSTRUCTIONS: Submit Not Research Determinations
    • INSTRUCTIONS: Submit Not Human Subjects Determinations
    • INSTRUCTIONS: Submit Not Engaged Determinations
    • INSTRUCTIONS: Submit Exempt Determinations
    • INSTRUCTIONS: Submit Expedited Review
  • Change: Need for instructions on providing the pre-review note for RNI submissions
    • Revised: Clarified with instructions on how to provide the RNI Pre-Review note
      • INSTRUCTIONS: Submit RNI Pre-Review for Full Board
      • INSTRUCTIONS: Submit RNI Committee Review
    • Change: Removing references to the intake coordinator position
      • Revised: Removing references to the intake coordinator position
        • INSTRUCTIONS: Incoming Items- New Studies (also minor correction)
        • INSTRUCTIONS: Incoming Items- RNI
      • Change: Need for instructions on how Compliance Administrators should document any consults for RNI submissions
        • Revised: Added clarification to existing instructions on how CAs should document consults
          • INSTRUCTIONS: Submit Not Non-Compliance Determination
          • INSTRUCTIONS: Submit Minor Non-Compliance Determination
          • INSTRUCTIONS: Submit RNI Pre-Review for Full Board
        • Change: Minor clarifications
          • Revised: Clarified that View Differences should also be used for modification submissions
            • INSTRUCTIONS: View Changes to a Study
          • Change: We have learned that review cannot be resubmitted for modifications
            • Revised: Added clarification that review cannot be resubmitted for modifications in review complete state
              • INSTRUCTIONS: Resubmit Review to Correct an Error
            • Change: Adding the Shared Regulatory Documents activity
              • • INSTRUCTIONS: Upload Shared Regulatory Documents
                • Added: New activity for staff to upload regulatory documents
              • Revised: Updated instructions to reflect where staff should put documents
                • INSTRUCTIONS: Manage Ancillary Reviews
                • INSTRUCTIONS: Staff Data Entry
                • TABLE: Zipline Attachments
              • Deleted: No longer needed with new activity
                • INSTRUCTIONS: Submit Ancillary Review (Staff Version)