June 29th, 2015

FDA Form 1572

The IRB will no longer require that the FDA Form 1572 be provided with submissions for investigational drug studies. This includes new study, amendment, continuing review, and report form submissions. Investigators must maintain an up-to-date version in their research records, as well as any previous versions.  Completed 1572 Forms must be submitted to the FDA and IND sponsors as per normal process.

New Risks in Investigator’s Brochures (IBs)

The IRB will no longer consider new risks reported in updated IBs as possible unanticipated problems according to the IRB’s reporting policy. The IRB defines an unanticipated problem as follows:

Any incident, experience, or outcome that meets all of the following criteria:

1. Unexpected (unforeseen by the researcher or the research participant) in terms of nature, severity, or frequency, given the research procedures and the subject population being studied; and
2. Related or probably related to participation in the research, or if the event or problem probably or definitely affects the safety, rights and welfare of current participants; and
3. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.

After evaluation of federal guidance on this topic, the IRB feels that an IB that has been updated with new risks does not constitute an incident, experience, or outcome that would require consideration using the three criteria above. An IB acts as a comprehensive document summarizing the body of information about an investigational drug product and will not be viewed as the official report of an incident, experience, or outcome observed in clinical research.

Investigators and sponsors are continually required to consider adverse events observed in clinical research, and it is the initial documentation and evaluation of these events that should be reported to the IRB using the three criteria above. These events may come in the form of direct adverse event reports (both internal and external), safety reports, monitoring reports, and other related documentation.

Investigators are still required to submit amendments with updated IBs in a timely manner, within 30 days of receipt. New risks are important new information that requires timely consideration by the investigator, the IRB, and the participants.  Late submission of amended IBs may be reviewed by the IRB for possible serious or continuing non-compliance.