Instructions on how to enter an IBC Amendment in iRIS- needed for all PAL(Personnel, Agent, Location) changes.
IF new bio/chemAgents are being added to your IBC protocol, please complete Addendum A or Addendum BWord form(s) FIRST.
Prefilled Addendum A (bio) &Addendum B (chemical) are in: iRISHome > 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 IBCAmendment Form Study Applicationonly.
1.Go to Save this link to your favorites or bookmark for future use.
2.Study AssistantMy 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 ApplicationthenSave and Continue
8.2.0Change 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, DeleteAdd personnel contraints (if any, e.g. Only PI may work with viruses). Save and Continue.
10.4.0Change in Lab Room #s.ʘ Yes or No. If yes, respond to 4 questions then Save and Continue.
11.5.0Change in Hazardous Agents. 5.1 Ifʘ Yes,type in the text box Add [new agent] orDelete [agent].
⃝ + Add a New Agent to the StudySave Agent Info. If deleting agent Delete AgentSave and Continue
IfʘNo changes tohazardous Agents (no adding or no deleting),Skip 5.2 Save and Continueand skip to Step 13.
12.5.2To attach appropriate addenda[WordAddendumA - 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.
13.6.0Change in Shipping. Respond ʘ Yes or No, then Save and Continue. Trained shipper needs documentation.
14.7.0Dual Use Research. Respond ʘ Yes or No, then Save and Continue.
15.8.0Revised 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 APPLICATIONrevision was already created. Click Edit/Viewinstead.
* Ifa new version of the application form has been published (due to iRIS updates), clickOK. Convert to the New Form Version.
17.Study Application.Click 1.0General Information(left side of screen).Save and ContinueRespondto all sections 1.0-7.0.New P.A.L. changesentered on the electronicAmendmentform arealso changed in theiRIS IBC protocolStudy Application.
Do not enter new personnel in ApplicationSection 3.0 KSP. Personnel is added or deleted later, intheApplication Section5.2.a.
⃝ + Add External Personnel to the StudyorDelete.List or change contraints on personnel (if any).Save & Continue to Next Section.
18.Attaching Study Application. SelectAttachedʘ Save Attachment. Save and Continue to Next Section.
19.Save Form. Save and Continue Signoff and Submit.ʘ Approve. Type webraiderlogin info. Save Signoff. That’s it!
Do not check the boxesfor Submission Form(s). Leave the boxes underInclude in PDF Packet unchecked. Checking the box is optional- only if you want to print your iRISsubmission (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 iRISis used to submit changes to the IBC protocol personnel, agents and locations.
The IBCStudy 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 changeto populatecurrent information on future submissions.
instructions ibc amendmentPage 1 of 2Revised 08/09/2017