Investigator Brochures, Patient Package Inserts & Safety Committee Summary Reports
Acknowledgement 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.
Please note that 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/or CRO contacts will receive the acknowledgement of receipt via Schulman’s WebPortal 3D and SiteAccess systems for the respective protocol(s). To obtain a hardcopy acknowledgement of receipt by mail, you must submit two (2) copies of the Product Safety Submission Form and a self-addressed stamped envelope or prepaid courier envelope.
Schulman requires that each revised IB/PPI and Safety Committee Summary Report be submitted in a timely manner using the Product Safety Submission Form. You must submit a summary of changes along with any revised IB/PPI. When a revised IB/PPI or Safety Committee Summary Report affects the Informed Consent (IC), a copy of the current Schulman approved IC must also be submitted with revisions indicated in track changes mode, or with handwritten changes noted on the most recent Schulman approved ICs.
Revised IBs/ PPIs and Safety Committee Summary Report, can be submitted to Schulman via:
Upon receipt of the submission, Schulman will review the revised IB/PPI or Safety Committee Summary Report along with the current Schulman approved IC(s) for each applicable open protocol. After this review, if the Board requests revisions to the IC(s) based on new information presented, Schulman will notify the designated sponsor and/or CRO contact person for each applicable open protocol. If revisions to the IC are approved, Schulman will apply those revisions to the template IC(s) and e-mail a draft IC(s) to the designated contact(s) for review and sign-off prior to issuing the approval letter.