You must submit all IC revisions to Schulman for review and approval prior to use, including consent changes not resulting from an amendment (for example a compensation change, an addendum, or additional safety information).
Please submit an electronic copy of the current Schulman-approved IC with revisions indicated in Microsoft Word track changes.
A Word version of the current Schulman-approved IC may be obtained by sending an e-mail request to Schulman.
Depending on the basis for the revision, revised ICs should be accompanied by one or more of the following:
- Protocol/IC Change Form
- Revised Compensation Form
- Change of Investigator Form
- Change of Site Information Form
- Product Safety Form
Include any requests for translations in the accompanying forms, as applicable, with your revised IC submission.
For more information on revised ICs, please reference Amendments.