Change of PI Principal Investigator (PI), Additional Contact, Study Staff How to submit a Modification to change the PI of an approved study

Transcription

1 Jb Aid Title Relevant Users Cvered Tpics Change f PI Principal Investigatr (PI), Additinal Cntact, Study Staff Hw t submit a Mdificatin t change the PI f an apprved study Active study staff r the utging PI must create a Mdificatin t change the Principal Investigatr fr an apprved study. The incming PI then submits the Mdificatin. Changing the PI cannt be dne using Edit Research Staff. 1. Create a mdificatin submissin If yu are the new PI and are ready t submit, skip t Step 3: Submit the Mdificatin. Once in the Parent study (i.e. the study s initial submissin in eirb) select the New CR/Mdificatin buttn shwn belw. Select Mdificatin in (1). Then, review the Current Prtcl Status in (2) and select any f the fur statements that are true r nt applicable. Click Cntinue. On the Mdificatin Summary page, check ff Changes t PI and any items in (1) that are true. Then in (2) prvide a descriptin and a justificatin f the mdificatin. List any dcuments that are being added/mdified with this submissin (i.e. infrmed cnsent frm, assent frm, required letter regarding change f PI, etc.). Change f PI (V2)

2 Once yu have finished with the Mdificatin Summary, click the Cntinue buttn. This allws yu t edit a cpy f the study s current apprved submissin. In sectin 1.0 Study Infrmatin, click Update next t the current PI s name. When the Add Principal Investigatr windw pens, click n Select in (1). Select the name f the new PI frm the list and click OK. This will bring yu back t the Add Principal Investigatr windw. Review (2) and (3) t make sure the questins abut cnsent and financial interest are answered crrectly fr the new PI. Edit if necessary. Then, click OK at the bttm f the windw. 2

3 At the tp f the page, click Cntinue r use the Jump T menu t navigate t any ther sectin(s) requiring editing. In sectin 7.0 Attachments, add a letter frm the utging PI agreeing t the change r a letter frm the department chair r supervisr explaining the reasn t prceed withut the previus (utging) PI's agreement. Fllwing the steps in the Hw t Manage Files in eirb Jb Aid, add r update any ther study dcuments. When yu have cmpleted the Mdificatin, either click the Finish buttn n 8.0 Final Page r click Save and then Exit at the tp f the page. 2. Ntify the New PI: If yu if yu are active study staff r if yu are listed as an Additinal Cntact n the study, click n Ready fr PI Review under My Current Actins n the submissin wrkspace t ntify the new PI. 3

4 ! TROUBLESHOOTING: If yu are missing the Ready fr PI Review buttn r if the new PI cannt see the submissin in All Studies, then active Study Staff must perfrm the fllwing steps: G t the main study (parent) and click n Edit Research Staff. Click OK at the bttm f the windw. Then, return t yur Mdificatin submissin (under the fllw-n submissins tab) and yu shuld see the buttn Ready fr PI Review under My Current Actins. It is advised that yu als cntact the new PI directly (utside f the system) t let them knw it is ready fr their review and submissin. Try the abve steps befre cntacting the IRB ffice. If yu cntinue t have issues, cntact the IRB ffice. 3. Submit the Mdificatin (New PI nly): If yu are the new PI, yu will receive a ntificatin in the listed in yur user prfile indicating that the submissin is ready fr yur review nce active study staff r the additinal cntact has clicked Ready fr PI Review. Yu will need t submit the mdificatin t change the PI. The previus PI will nt be able t submit. Click n Submit under My Current Actins. Yu will knw that yu have submitted successfully when the submissin s state in the upper left-hand f the screen has changed frm Pre-submissin t Pre- Review. 4

5 TIPS: Once study staff has prepared the submissin fr yur review, yu can find the submissin under ALL STUDIES. Refer t the Hw t Navigating t Find Existing Studies Jb Aid that describes hw t find yur eirb studies. If yu need t update yur cntact infrmatin (e.g. address), refer t the Hw t Edit User Prfile Jb Aid that describes hw t edit yur eirb user prfile. 5