How to Submit a Human Post-Approval Activity (PAA) - Amendment
description
Transcript of How to Submit a Human Post-Approval Activity (PAA) - Amendment
![Page 1: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/1.jpg)
How to Submit a Human Post-Approval Activity (PAA) -
Amendment
![Page 2: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/2.jpg)
Click on the Human Ethics tab to view all your Human Ethics
applications
![Page 3: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/3.jpg)
Click on the Name of the study for which you would
like to submit a PAA
![Page 4: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/4.jpg)
Click to create a new PAA
![Page 5: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/5.jpg)
Here is a list of PAA options:
![Page 6: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/6.jpg)
Select Amendments to Study and click “Continue”
![Page 7: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/7.jpg)
PAA-Amendment Coversheet
Complete all applicable questions and summarize the amendments you are making to your study/application
Refer to the guidance notes located in the gray boxes for detailed explanations of the questions, instructions on how to fill out the form and useful links to documents and contacts
The first time you “Save & Close” out of the Amendment Coversheet, you will automatically be taken into the application where you will make your amendments
![Page 8: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/8.jpg)
Page 1 of the Application
![Page 9: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/9.jpg)
Page 1 of the Application
Use the Jump to: tool to navigate the pages of the application
Click “Save” between pages and before you “Exit” the application
![Page 10: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/10.jpg)
PAA Homepage
A PAA number is assigned to the original study ID numberTo track the status of your PAA through the approval process, refer to the “Current
State” box
As the state of your PAA is “Pre Submission”, your PAA Coversheet and your application are still open for any edits you may want to make
![Page 11: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/11.jpg)
Edit the Amendment Coversheet and click Save & Close to return to the PAA Homepage
![Page 12: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/12.jpg)
Click to continue making amendments to your study/application
![Page 13: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/13.jpg)
Use the Jump to: tool to navigate and make any additional amendments to the application
“Save” and “Exit” when changes are complete
![Page 14: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/14.jpg)
Click to submit your PAA for review
![Page 15: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/15.jpg)
Click “Ok” to send your PAA for review
![Page 16: How to Submit a Human Post-Approval Activity (PAA) - Amendment](https://reader035.fdocuments.in/reader035/viewer/2022062501/5681680a550346895ddd9061/html5/thumbnails/16.jpg)
Your PAA – Amendment has been submitted to the REBA for review