Complete Submissions & Studies on Hold
Please note that we will start working on any and every complete submission (i.e. all smart form questions have been answered) that includes the mandatory documents.
Please don’t click on “Submit to HRA” (i.e. submit your study), if you are not ready for us to start working on your submission. This is because we want to make sure that we are using the final version of mandatory documents in our processes.
In addition, we will send the following submissions back to “Returned to Presubmission” in True 2.0. You will need to resubmit, (i.e. Submit to HRA in True 2.0) when your submission is ready for our processing.
- On hold due to FDA review
- On hold due to sponsor for more than a month or when there is an expectation of change in the study protocol
- On hold due to PI not being ready to move forward
- On hold due to unavailability of funds