Instructions on How to Enter an IBC Amendment in Iris - Needed for All PAL ( Personnel

Instructions on how to enter an IBC Amendment in iRIS - needed for all PAL (Personnel, Agent, Location) changes. IF new bio/chem Agents are being added to your IBC protocol, please complete Addendum A or Addendum B Word form(s) FIRST. Prefilled Addendum A (bio) & Addendum B (chemical) are in: iRIS Home > My Assistant > Operating Procedures > IBC Forms. Addenda should be saved with filename: Addendum Type - [bio/chem]. Example: Addendum A - blood or Addendum B - nicotine. No Word documents are needed for Personnel or Location changes - enter P & L changes on IBC Amendment Form & Study Application only.

1. Go to https://www.ttuep.imedris.net Save this link to your favorites or bookmark for future use. 2. Study Assistant > My Studies 3. Display my Studies by:  IBC Number

4. Click the icon 5. IBC FORMS Click IBC Protocol Amendment Form .

6. Click Add a New Form

7. 1.0 Answer 3 questions (PI’s Title, Lab Phone, Room #s on license) in Section view of Application then Save and Continue

8. 2.0 Change in KSP. Do not add personnel here. No responses needed. Just Save and Continue 9. 3.0 Change in Lab Personnel. ʘ Yes or No. If yes, list the changes in box (e.g., Add Li Wen or Delete Ann Jones).

⃝ + Add External Personnel to the Study (Role: Research Assistant). Save External Personnel. To delete lab personnel, Delete Add personnel contraints (if any, e.g. Only PI may work with viruses). Save and Continue.

10. 4.0 Change in Lab Room #s. ʘ Yes or No. If yes, respond to 4 questions then Save and Continue. 11. 5.0 Change in Hazardous Agents. 5.1 If ʘ Yes, type in the text box Add [new agent] or Delete [agent].

⃝ + Add a New Agent to the Study Save Agent Info. If deleting agent Delete Agent Save and Continue If ʘ No changes to hazardous Agents (no adding or no deleting), Skip 5.2 Save and Continue and skip to Step 13. 12. 5.2 To attach appropriate addenda [Word Addendum A - Biological or Addendum B - Chemical] with your submission, Add a New Document. Browse… retrieve completed Word Addendum A/B for new bio/chem agent saved on computer desktop or other file. Save Document for each new agent. After all Word addenda is attached Save and Continue.

13. 6.0 Change in Shipping. Respond ʘ Yes or No, then Save and Continue. Trained shipper needs documentation.

14. 7.0 Dual Use Research. Respond ʘ Yes or No, then Save and Continue.

15. 8.0 Revised Materials. 8.1 Attach your revised application for the PAL changes. Click here to attach the application.

16* Create a Revised Application Add Revision Confirm the adding a revision. Are you sure you want to create a revision? OK

If Add Revision does not show, it’s because the STUDY APPLICATION revision was already created. Click Edit/View instead. * If a new version of the application form has been published (due to iRIS updates), click OK.  Convert to the New Form Version.

17. Study Application. Click 1.0 General Information (left side of screen). Save and Continue Respond to all sections 1.0 - 7.0. New P.A.L. changes entered on the electronic Amendment form are also changed in the iRIS IBC protocol Study Application. Do not enter new personnel in Application Section 3.0 KSP. Personnel is added or deleted later, in the Application Section 5.2.a.

⃝ + Add External Personnel to the Study or Delete . List or change contraints on personnel (if any). Save & Continue to Next Section.

18. Attaching Study Application. Select Attached ʘ Save Attachment. Save and Continue to Next Section.

19. Save Form. Save and Continue Signoff and Submit. ʘ Approve. Type webraider login info. Save Signoff. That’s it!

0e49daf4812be23c969ed91f442e167e.docx Page 1 of 2 Revised 08/09/2017 Do not check the boxes for Submission Form(s). Leave the boxes under Include in PDF Packet  unchecked. Checking the box is optional- only if you want to print your iRIS submission (Amendment, Study Application & Bio/Chem Addenda) to PDF (and have another file to save in your computer). All previous submissions and attachments are already saved in iRIS, in Submissions History.

Step 16* If you receive this notice, ALWAYS click OK: Then, click Convert to the New Form Version

The IBC Amendment Form in iRIS is used to submit changes to the IBC protocol personnel, agents and locations. The IBC Study Application “holds” all current IBC protocol information. The Study Application in the Amendment (n/a in the ASR) needs to be updated (or corrected) with each PAL change to populate current information on future submissions.

0e49daf4812be23c969ed91f442e167e.docx Page 2 of 2 Revised 08/09/2017