Before your submission can go before the board members of the IRB, the IRB staff ensures that all the necessary components of your submission are present and complete. When your submission is initially received by the IRB staff, an internal review of your materials is done to ensure completeness. If the staff notes any deficiencies or missing pieces of information, your submission will be rejected back to the original submitter, along with notes about what needs to be corrected. The submitter is notified of any rejections via email.
The principal investigator of a clinical trial/research project is ultimately responsible for all aspects of the study, including submissions to the reviewing IRB. The PI must approve each submission that is sent to the IRB.
The submitter can track their electronic submission(s) by logging onto the IRBManager website, and going to the link called “xforms” (there will be a number in front of this link, which indicates how many xforms).
Electronic submissions- you have put through the system. Click on the “xforms” link under “My Documents and Forms” and you should be taken to a table which shows the current status of each xform. Note the “stage” that the xform is in; Stages of an electronic submission for an explanation of the stages that an xform goes through.
To ensure adequate documentation that the PI has approved all submissions. Because of issues many institutions and software companies have faced in being compliant with the regulations that govern electronic signatures, federal auditors have recommended that we maintain one, signed, hard copy on file. We anticipate that this hard copy will eventually not be required as the regulations and development of software evolve.
After your submission has been reviewed and a decision has been made by the IRB, your administrator will send you an email, notifying you that your materials are available for retrieval. Please refer to this document for guidance on how to pick up approval documents. Any approval/decision materials will be located in the attachments section of your recent submission event. Contact the IRB Office if you need any assistance with retrieving materials.
Immediately after you complete an electronic submission (and hit “Submit to the IRB” on the last page), an email is auto-generated to the PI for that study. This email requests that the PI approve that the submission goes forward to the IRB, and contains a link to your submission. The PI must approve that the submission go forward to the IRB, otherwise the IRB office never receives the submission. The PI needs to click on the link contained in the email, which will take the PI to the IRBManager website. There, the PI must sign in, and then the submission will open up. The PI must review what you have submitted, and electronically “sign”/approve the submission on the last page. See the Screen shots - making electronic submissions for an existing study for how a PI approves submissions using the email link
After the PI has electronically signed/approved the submission, the submission moves forward to the IRB office, where it will undergo an internal staff review before it is reviewed by the IRB. If the submission is complete, it will be scheduled for review. If the submission is incomplete, the IRB office will “reject” the submission back to the submitter for changes.
The PI must electronically sign each submission that is submitted. The IRB office does not receive any submissions that have not been approved by the PI. It is critical that the PI electronically sign and approve each submission; without this electronic signature, the submission is not advanced into the IRB office, and the study may fall into non-compliance status if any submission deadlines are missed.