IND & IDE Support FAQs

a)  Phone contact

b)  Virtual visit

c)  Alternative location for assessment, including local labs or imaging centers

No, unless the sponsor is incorporating the data collected as part of a new research objective.

a)  The reason any contingency measures were implemented

b)  How the restrictions related to COVID-19 led to changes in study conduct and duration of those changes

c)  Indicate which trial participants were impacted and how those trial participants were impacted

Yes, it is important to capture specific information in the case report forms that explains the basis of the missing data, including the relationship to COVID-19 for missing protocol-specified information.

a)  Contingency measures implemented to manage study conduct during disruption of the study

b)  A listing of all participants affected by the COVID-19 related study disruption by unique subject number identifier and by investigational site, and a description of how the individual’s participation was altered

c)  Analyses and corresponding discussions that address the impact of implemented contingency measures (e.g., trial participant discontinuation from investigational product and/or study, alternative procedures used to collect critical safety and/or efficacy data) on the safety and efficacy results reported for the study.

Yes, you should continue to submit annual reports to the FDA during this time.

No, expedited reporting of suspension enrollment is required if participant safety is compromised due to the study intervention.

For a study-wide change in protocol conduct, protocol amendments that are necessary to prevent imminent hazards to participants can generally be immediately implemented with subsequent submission and formal approval by the IRB and notification to FDA through filing a protocol amendment to the IND or IDE.

Protocol amendments that are NOT required to prevent imminent safety risks to patients can be implemented once they are submitted to FDA and IRB approval has occurred.

For IND studies, the sponsor should submit a formal amendment to its IND, with the following information added to the cover letter in the subject line:

PROTOCOL AMENDMENT – COVID-19

TITLE OF PROTOOL

In the cover letter, sponsors should summarize the major changes made to the protocol related to COVID-19.  Sponsors should provide the FDA with a clean and tracked changes of the protocol and the consent (if applicable)

For IDE studies, the sponsor should submit a supplement to its existing IDE, with the following information added to the cover line in the subject line:

CHANGE IN PROTOCOL SUPPLEMENT – COVID-19 or NOTICE OF IDE CHANGE – COVID-19, as applicable

TITLE OF PROTOCOL

In the cover letter, sponsors should summarize the major changes made to the protocol related to COVID-19.  Sponsors should provide the FDA with a clean and tracked changes of the supplement and the consent (if applicable)

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.

For a change in Investigator, the FDA must be prospectively notified within 30 days of the investigator being added.  For sub-investigator changes, prospective notification is not necessary; however, this information should be included with the next Annual Report and the Form FDA 1572 should be updated in the regulatory file.     

It is recommended that you first submit to the IRB.  Upon IRB approval, you should then submit to the IIS office and we will forward to the FDA.  Please note: All FDA submissions must include a signed and dated Form FDA 1571.