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Amendments

SponsorsUnder normal conditions, you must submit to the Board all amendments, including administrative letters, or changes to the protocol for review and approval prior to the implementation.

When submitting a revised protocol, provide a summary of changes between the revision and the previously reviewed version.

Occasionally, safety concerns may require you to implement an amendment prior to Board approval. When changes to the protocol are implemented in order to eliminate an apparent immediate hazard to a research subject without prior Board approval, you must report changes to Schulman within 10 business days.

Administrative changes to a protocol generally require Board approval. However, when you submit changes that are limited to typographical corrections or changes in contact information, Schulman will acknowledge receipt. Board approval is not required for these.

Each amendment submitted to Schulman must be accompanied by:

  • Protocol/IC Change 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.

A Word version of the current Schulman-approved IC may be obtained by sending an e-mail request to Schulman. For information on revising electronic informed consents (eICs), please reference Electronic Informed Consent (eIC).

Amendments and revised ICs can be submitted to Schulman via:

Amendments turnaround times vary and timeline expectations differ from new studies. Times vary based on a Board member determination that an amendment may be approved by expedited review or if it must be reviewed by the full Board. This pre-review may take 2-4 business days. Full Board reviews take longer. Please note: Canadian protocols are currently reviewed only at Friday Board meetings.

When an amendment results in revision to the IC(s), Schulman will finalize the revisions prior to issuing the amendment approval letter.