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What More Do We Want?

What More Do We Want?. Specific Minor Revision Letters. SMR Letter-who does it come from?. Either from Full or Expedited Committee. The letter from the Full Committee is generally ready by Friday afternoon after the meeting. This will be either a paper letter or via COEUS.

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What More Do We Want?

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  1. What More Do We Want? Specific Minor Revision Letters

  2. SMR Letter-who does it come from? • Either from Full or Expedited Committee. • The letter from the Full Committee is generally ready by Friday afternoon after the meeting. This will be either a paper letter or via COEUS. • The letter/email for expedited review is sent the day of the review.

  3. What does the SMR letter mean? • SMR means specific minor revisions • Each SMR letter has bullets that are informational (risk level, contact information) and bullets that specify requested or required action. • Annotated consent forms may be included with the letter; these changes are also required. • Letters may contain very specific suggested language; it is ok to use this language or use your own language as long as the basic concepts are not changed.

  4. SMR Letter continued! • The HIC contact person is listed-please communicate with this person because this is the person who knows your protocol best!!!! • Do not submit the original SMR letter with your revisions-this letter should be filed in your study binder so that there is a paper trail of actions on the protocol. • DO submit a memo that responds to each bullet point.

  5. Do you want to reduce or eliminate Specific Minor Revisions letters? • Avoid these common submission pitfalls!! • Wrong versions of research documents submitted • Waiver statement missing from CF • HIPAA and HSPT Training-make sure all staff are trained prior to submission • Contact info for PI on last page of consent form missing

  6. Pitfalls continued! • In Case of Injury - is not consistent with contract- contact your G and C person. • Discrepancies between application and consent documents-doses, arms, compensation, economic considerations, staff…. • On the consent form, all authorization information (including the validation box) is not on one page

  7. SMR Responses • Revisions submitted in response to both Full Committee and expedited review are completed in the office via expedited review by the regulatory analysts. • If the PI response has addressed each bullet of the SMR letter, prompt review is completed and (hopefully) approval is granted. • If the PI has addressed each bullet of the SMR letter, AND also wants to make other changes to the protocol, contact the HIC correspondent. Additional changes may require full Committee review.

  8. SMR Responses continued • For example: Change in risk level or increased side effects do not = minor changes. For example, the addition of death as a side effect must go to Full Committee. • An amendment request to address a substantive change can be submitted as soon as the revisions requested are approved.

  9. SMR Responses cont. • Sponsors may want to review changes prior to revisions being submitted for approval-CHECK WITH THEM. You don’t want to have us approve revisions only to have the sponsor reject them.

  10. Response letter/memo from PI • To minimize review time, the response letter should address Expedited or Full Committee concerns point by point. One way to do this is to copy each HIC bullet into the PI response memo. • Make sure the location of each change is clearly stated in this memo, Ex. Page 5/12 • Each document must be track changed for ease of review-- which generally equals quicker turnaround.

  11. Response letter/memo cont. • IF you disagree with the Committee’s opinion, the bullet should still be addressed, as this will let us know that the request was not overlooked. • This could require discussion with the Chair or Full committee review depending on the risk level. This will have to be re-reviewed by the Committee that originally reviewed the action(initial,renewal,amendment).

  12. What to submit! • All revisions must come to the HIC office as hard copies if you submit via paper. • Submissions via COEUS require tracked versions layered properly. • Memo-responding to requested/required changes. • Tracked change versions (1) of each document that required changes. • Clean copies (2) of each document so that theya can be validated: 1-PI and 1-HIC file

  13. And Also • We’re here to help! • Call (203-785-4688) or email us at ysmhic@yale.edu with general questions • Call or email your HIC correspondent with specific questions about your SMR letter.

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