Do I need to submit case report forms to the FDA with my new drug or new device application?
No, these are not necessary for the FDA submission. However, please note that study-specific case report forms or data collection forms must be submitted to O3IS prior to IRB approval of the protocol.
Why do I need to bring submissions to O3IS instead of sending directly to FDA?
The FDA communicates directly with the Sponsors of IND and IDE applications and holds these communications confidential. Hence, the FDA does not include or copy the University on these communications. However, the University of Pittsburgh is potentially liable for the actions of its faculty members, thus necessitating that the University be engaged in the communications. The University must be involved in the oversight and must also ensure appropriate monitoring of the progress and appropriate conduct of this type of clinical trials.
If there is a change in Investigator for an IND, how soon should the FDA be notified?
For a change in Investigator, the FDA must be prospectively notified within 30 days of the investigator being added. For subinvestigator changes, prospective notification is not necessary; however, this information should be included with the next Annual Report.
What documents are required for submitting an unanticipated adverse device effect report to the FDA?
For IDE’s, please submit the following:
1) Cover letter that includes the following:
a) IDE #
b) Device Information
c) Sponsor-Investigator Contact Information
2) A report of the Unexpected Adverse Device Effect. The narrative report should include the following:
a) Description of the event
b) Summary of UAP/Unexpected Adverse Device Effect, including a discussion of DSMB and IRB reviews of the incident and outcomes of the event
Please see the link below for the time frame of reporting unanticipated device effects to the FDA.
What documents are required for submitting an IND Safety Report to the FDA?
a) Cover Letter
b) Form FDA 1571
c) Form FDA 3500A
d) Narrative description of the event, including a discussion of DSMB and IRB reviews of the incident and outcomes of the event
Please see the link below for the time frame of reporting IND Safety Reports to the FDA.
When submitting protocol modifications, should I first submit to the IRB or the FDA?
It is recommended that you first submit to the IRB. Upon IRB approval, you should then submit to the O3IS office and we will forward to the FDA. Please note: All FDA submissions must include a signed and dated Form FDA 1571.
How do I know if I should register my study on Clinicaltrials.gov?
Please follow the link below:
Whom should I contact about registering my study on Clinicaltrials.gov?
To initiate the clinical trial registration process, a PI must establish an account with the ClinicalTrials.gov Protocol Registration System (PRS) by sending an e-mail message to the University’s PRS administrator, Susan Sandusky, at CTgov@pitt.edu. The subject line must state “Protocol Registration” and the body of the message should contain the PI’s name, telephone number, and e-mail address.
After receiving notification that an account was created by the University’s PRS administrator, the PI can complete the registration process by accessing the ClinicalTrials.gov Protocol Registration System Information Website (http://clinicaltrials.gov/ct2/manage-recs) and following the directions for registration of any and all “applicable clinical trials.” A unique identifier, called an “NCT” number, will be generated during the registration process after the NIH’s PRS QA Review. This number should be used for NIH reporting purposes and for manuscript submissions. If you do not have an “NCT” number then the trial is not registered.
Please contact our office after you receive your NCT number.
Where to Begin
Am I required to submit an IND or IDE application?