Investigator Brochures, Patient Package Inserts, DSMB & Safety Committee Summary Reports

SponsorsAcknowledgement of receipt is provided for all Investigator Brochures (IBs) and Patient Package Inserts (PPIs) included with the initial protocol submission.

Acknowledgement of receipt is also provided for all Safety Committee Summary Report submissions.

Use the Product Safety Submission Form to submit revised IBs or PPIs, including a summary of changes with the revised document.

IBs and PPIs are not approved by the Board, however an acknowledgement of receipt will be provided when revised IB or PPI submissions include the Product Safety Submission Form. Site, sponsor and CRO contacts will receive acknowledgement via the WebPortal 3D and SiteAccess systems for the respective protocol.

When a revised IB/PPI, data safety monitoring board (DSMB) or independent safety committee summary report affects informed consents, submit a copy of the current Schulman-approved consent with revisions as discussed on the Revised Informed Consent page. After review, if the Board determines consent revisions are required for any open protocol, we will follow the revised informed consent process in coordination with the appropriate protocol contact.

If the protocol includes a DSMB or independent safety monitoring committee, please submit the DSMB or committee minutes or a summary of its findings in a timely manner using the Product Safety Submission Form. If a revised IB/PPI or DSMB/safety committee summary report involves an unanticipated problem, reference the Unanticipated Problems page to ensure proper reporting.

Revised IBs/PPIs, DSMB and safety committee summary reports may be submitted to Schulman via: