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.
 The letter/email for expedited review is sent the day
of the review.
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.
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.
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
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
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.
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.
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.
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.
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).
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
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.