Amendments
You must submit all amendments or changes to the protocol (“amendments”) to the Board for review and obtain approval from the Board prior to implementing the proposed amendment or change. Administrative changes to a protocol generally require Board approval. If the administrative change is limited to a correction of typographical errors or a change in personnel, Board approval may not be required.
Occasionally, safety concerns may necessitate the implementation of an amendment prior to Board approval. When changes to the protocol are implemented without prior Board review, it must be reported to the Board within ten (10) business days.
Each amendment submitted to Schulman must be accompanied by:
Protocol/IC Change Submission Form
A summary of changes if a new version of the protocol is provided.
A copy of the current Schulman approved IC* (if applicable) with revisions indicated in Microsoft Word track changes or with handwritten changes, if necessary. Do not submit changes via disk.
*An electronic copy of the current Schulman approved IC may be obtained by sending an
e-mail request to Schulman.
Amendments and revised ICs can be submitted to Schulman via:
The turnaround time for review of amendments depends on whether an amendment must be reviewed by the full Board or can be reviewed by expedited review. If full Board review is necessary, Schulman must receive all documents no later than noon (12 p.m. EST) three (3) business days before the meeting date. Please note: Canadian protocols are currently reviewed only at Friday Board meetings.
When an amendment results in revision to the IC(s), 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 amendment approval letter.