Submission Examples and Guidance

NOTICE:

IRBWISE will be closed to ALL new submissions on Monday, December 16, 2024. Any new submissions, submitted to the IRB on or after 12/16/2024 will be administratively withdrawn and you will be asked to re-submit in Cayuse - Human Ethics

PLEASE NOTE: If you have submissions that are currently with the study team/PI please submit them back to the IRB before Friday, December 20th, 2024 for processing. Any submissions in a pending state after 12/20/2024 will be administratively withdrawn and study teams will be asked to re-submit in Cayuse - Human Ethics

IRBWISE will be transitioning to READ ONLY on Monday, January 6th, 2025. Study teams will only be able to read their submissions and download study documents.

Cayuse - Human Ethics Module Training Session:

The Georgia Tech IRB will be having a training session for our new protocol submission system. Please join the IRB team Friday December 13th, 2024 from 12:30 to 1:30 for a Cayuse - Human Ethics Module training session. 
Join the meeting!

Please join the IRB team Friday December 6th, 2024 from 12:30 to 1:30 for a Cayuse - Human Ethics Module training session. 
Join the meeting!

Study Transition from IRBWISE to Cayuse - Human Ethics Module

All Full Board and Expedited Studies must be transitioned from IRBWISE to Cayuse by Jan. 31, 2025. 

Active Protocol TypeTransitioned DataStudy Team Action
Full BoardIRBWISE Protocol Number, Title, PI and Study Team Members, PDFs of the IRBWise Submissions excluding personnel only amendments, IRB approved study documents, and the most recent approval letter.

The study team will need to review the Legacy documents uploaded by the IRB Staff and ensure the information is accurate. If there are inaccuracies or missing information, the study team will need to submit a Modification to adjust any information. 

Please see the following guidance should you have any questions regarding Full Board Legacy Studies or Modification Submissions in Cayuse. 

Cayuse - Full Board - Legacy Submission Guidance

Cayuse - Help Center - Creating a Modification Submission

ExpeditedIRBWise Protocol Number, Title and PI

The study team will need to create a Legacy Submission and upload approved documents, consent forms, and approval letters. The IRB Staff would like to request that study teams create a PDF of the IRBWise Protocol and upload it here as well. 

Please see the following guidance should you have any questions regarding Expedited Legacy Studies.

 Cayuse - Expedited - Legacy Submission Guidance

ExemptDue to the volume of exempt studies, these have not been transitioned.

The study team will need to create a New Study and complete the Initial Submission. Once they have created an initial submission, the study team should input all of the exact same information listed IRBWise from their current approved protocol. This will allow the IRB staff to process these submissions in a timely fashion. 

Please see the following guidance should you have any questions related to creating a new study or completing an initial submission. 

Cayuse - Help Center - Creating a New Study 

Cayuse - Human Ethics Module

These documents and articles will provide examples and guidance for the different types of submissions in the Cayuse - Human Ethics Module. All screen shots are examples only and responses are not to be interpreted as the only correct response unless otherwise stated. Contact the Office of Research Integrity Assurance with any questions. 

IRBWISE

These documents provide examples of different types of submissions in IRBWISE as well as guidance for each IRBWISE section. All screen shots are examples only and responses are not to be interpreted as the only correct responses. Contact the Office of Research Integrity Assurance with any questions.