May 16, 2012
Protis transfer procedures
Protis, USU's online program for submitting and tracking research protocols, is well underway, and the Institutional Review Board is now working to retroactively transfer previous paper protocols to the system. All investigators who have pre-Protis approved applications and who are still conducting research have the option to transfer their protocol to Protis.
"Having a protocol live inside Protis will allow an investigator ready access to their protocol (and all its documents, reviews, history, amendments, etc.) from any computer at any time," said Ture Rubal, IRB administrator.
The IRB used the paper version of the application for several years, but now exclusively (as of Jan. 1, 2012) uses Protis for all its applications and amendments, and soon status update requests.
"If faculty have an open protocol with an expected completion date of more than one year (whether they're still recruiting participants, closed to new participants, or are in the data analysis phase), they might want to consider transferring their study to Protis," said Rubal.
Instructions for making the transfer are listed below. Researchers deciding to move to Protis should let the IRB know. IRB staff will send back a zip folder with the complete protocol along with transfer instructions.
Procedures for transferring a previously-approved IRB protocol into Protis:
- Log into Protis and create a new Protis application. This will generate a new protocol number which we will replace with the old protocol number after it has been submitted to us.
- Include the old IRB protocol number (without the # sign) at the beginning of the title. Including the old number in the title will alert us that the new application is a replacement for a previously-approved “paper” application. After the protocol has been submitted to the IRB, we will re-number the application using the old number in order to help you keep continuity with your records (i.e., reports, Informed Consent, approval letters, etc.)
- As you work your way through the new Protis application (feel free to cut and paste from the previously-approved application as you complete each section), make sure they reflect the current [approved] status of the protocol (i.e., amendments, researchers, instruments, etc.). The Protis application has a slightly different order than your “paper” version. You can use the “word search” function when matching up sections in order to cut and paste from the old format to the new format.
- Upload all appropriate documents in the applicable sections of the Protis application. This should include the current approved versions of the proposal, instruments, informed consent, etc.)
- Upload in the last section of the Protis application (the Submit Protocol section) all of the approved amendments to date. Label them Amendment 1, Amendment 2, etc. (make sure you leave off the # sign. Protis does not recognize this character, thus making it impossible to open the uploaded documents).
- If you want to change the protocol in any way from what is currently approved, first submit the new Protis application. Once it’s been given the “green light” by our office, you will be able to amend as needed and proceed with your research.
- True Rubal