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Guidance for the Submission of Investigator's Drug Brochures (IDBs) and Package Inserts
In order to approve research studies under the Common Rule (45 CFR 46) or FDA regulations (21 CFR 56), an IRB must receive sufficient information about the effects of any drug under study to assess whether the risks to subjects are reasonable in relation to anticipated benefits and adequately minimized. For studies conducted under an investigational new drug (IND) application FDA guidance notes that an investigator's drug brochure (IDB) is usually required by the FDA (21 CFR 312.23(a)(5) and 312.55). In addition, FDA guidance states that even though 21 CFR 56 does not mention the investigator's brochure by name, much of the information contained in such brochures is "clearly required to be reviewed by the IRB" (FDA Information Sheets at http://www.fda.gov/oc/ohrt/irbs/faqs.html). The FDA provides flexibility to IRBs regarding when IDBs are required to be submitted, the format for submission, and how the IRB assesses the brochures. When to Submit IDBs Versus Package Inserts If a research study involves testing or evaluating drug(s) and their use in the research is covered under an IND, an IDB should be provided to the IRB. For any drugs being tested or evaluated as part of the research that are FDA-approved and an IND is not required for their use in the research, the study team should provide the IRB with package inserts rather than IDBs. Note: Many studies involve using a combination of drugs, some of which may be covered by an IND and some of which may not be. Many studies involve other FDA-approved drugs used within their approved indication but which are not the focus of the investigation. Examples include drugs to mitigate side effects, eye drops used in a standard eye exam, or lidocaine. The IRB may request package inserts or other documentation in these cases, so that the IRB is able to assess whether there are additional risks to study participation. Finally, there may be cases where Sponsors require specific documentation related to drug(s) under investigation to be submitted for IRB review (e.g. the Sponsor may require investigators to submit an IDB for a drug, even though it is FDA approved and not covered by an IND). The IRB typically accepts such documentation when it is a Sponsor requirement. Please see the IDB and Package Insert Decision Tree for assistance in determining which documents should be provided to the IRB. When to Submit Revised IDBs or Package Inserts as a Change of Protocol If a study team was required to submit an IDB and/or package insert at the time of the initial review of the research study, updates to the IDBs and/or package inserts also must be submitted to the IRB. How and when study teams should submit these IDBs and/or package inserts to the IRB depend on the whether the document(s) includes revisions that:
Version Date: May 21, 2018
- affect the risk/benefit ratio of the study (i.e., will result in a change to the study documents);
- affect alternatives to study participation for subjects; OR
- represent new information that should be provided to subjects.
- The revised IDBs/Package Inserts do NOT contain revisions that (1) affect the risk/benefit ratio of the study for study subjects (i.e., will result in a change to study documents); (2) affect alternatives to study participation for subjects; or (3) represent new information that should be provided to subjects; or
- The information contained in the revised IDBs and/or package inserts has already been assessed by the IRB (e.g., through a change of protocol); or
- The study is permanently closed to enrollment locally, no local subjects are on treatment, and the revised IDB and/or package insert contains no new information that would affect past subjects (e.g. new latent risks).