Studies that use drugs and submit Investigator’s Drug Brochures (IDBs) and/or package inserts at initial review need to submit revised IDBs/package inserts to the IRB for the life of the study. Revised IDBs/package inserts should be reviewed by the PI and can be submitted at continuing review or as a change of protocol depending on the nature of the revisions.

If the revisions WILL NOT result in a change to the protocol and/or informed consent form, then the revised IDB/package insert should be submitted at continuing review. Along with the revised IDB and/or package insert, the study team must complete the IDB and Package Insert Log to explain why the revised IDB and/or package insert meets criteria to be submitted at continuing review. The explanation should be specific to the submission and take into account the nature of the revisions, information already in the protocol and/or consent form, and/or the status of the study.

Some reasons you may be able to submit revised IDBs/package inserts at continuing review:

• The revised package insert includes editorial and administrative updates and does not include any new risk information.
• The revised IDB includes changes in frequency of risks, but the frequency changes do not impact the categories described in the consent form.
• The revised IDB includes new risk information, but all participants are off treatment, and the risk information is only relevant to those currently on the drug.

If the revisions WILL result in a change to the protocol and/or informed consent form, then the revised IDB/package insert must be submitted as a change of protocol to the IRB within 60 days. If the revised study documents cannot be submitted to the IRB within 14 days of learning the new information, however, then a new information report should be submitted as a placeholder until the full change is submitted within the 60-day window. Some reasons you may need to submit a change of protocol, and a new information report if needed

• The revised IDB includes a new risk not described in the consent form and participants are still on the study drug.
• The revised IDB includes changes in frequency of risks and the frequency changes do impact risk categories described in the consent form (e.g., risk is moving from the common to the very common category).

Please see Investigator Manual: FDA Regulations and IRB Review for more information.