7.2 General Considerations

The IB should include:

7.2.1 Title Page

This should provide the sponsor’s name, the identity of each investigational product (i.e., research number, chemical or approved generic name, and trade name(s) where legally permissible and desired by the sponsor), and the release date. It is also suggested that an edition number, and a reference to the number and date of the edition it supersedes, be provided. An example is given in Appendix 1.

7.2.2 Confidentiality Statement

The sponsor may wish to include a statement instructing the investigator/recipients to treat the IB as a confidential document for the sole information and use of the investigator’s team and the IRB/IEC.