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Modifications and Amendments Submission Form
The IRB reviews proposed modifications, amendments, and changes to previously approved research. Please fill out this form for revisions to the consent form, amendments and changes to the protocol, updated study product information, study related materials and recruitment materials. Sterling IRB will review all submissions for accuracy and to ensure compliance with applicable regulations. Refer to the Investigator Handbook for additional information as well as guidance on required attachments. Please complete this form and send form and attachments via SilverLink or email.SUBMISSION INFORMATION
Completed By: Site Sponsor CRO SMODate: / Submission on behalf of all active investigators: Yes No* (*Indicate PI name below or attach list of selected sites) / Sponsor:
Sterling IRB ID#: / Protocol No.: / Principal Investigator:
Material(s) being submitted: / Revision Date (if applicable): / Version Date (if applicable):
A. TYPE OF SUBMISSION (COMPLETE THE SECTIONS THAT APPLY)
NOTE: The IRB requires a complete description and rationale for all modifications and amendments.
Section 1. Change in Site Information (e.g. change of address, sub-I, compensation or SilverLink contacts):Please complete the Change in Site Information form located on our website at www.sterlingirb.com under forms.
Section 2. Change to the Protocol:
Administrative Change Correction to the Protocol
Amendment involving change in risk Amendment involving new findings
Amendment involving changes in or new procedures Other (Please describe):
Does the submission require a change to the IRB approved consent form? No Yes*
*If yes, please attach a copy of the current IRB approved consent template with handwritten or electronically tracked changes.
Does the submission affect the following items? Protocol Title: No Yes* Protocol Number: No Yes* Sponsor name: No Yes*
*If yes, please list the new protocol title, protocol number, and/or Sponsor name:
Please provide the following with each amendment:
Rationale for the amendment and summary of changes to the Protocol
If the amendment is due to updated safety information, please provide the source documentation (i.e. revised Investigator’s Brochure, Dear
Investigator letter, DSMB report).
Section 3. Revised Product Information:
Revised Investigator’s Brochure*+ Revised or Additional Package Insert+
Addendum to the Investigator’s Brochure*+ Revised Device Manual
Other (please describe):
*Please provide safety reporting cut-off date:
Please provide a summary of changes with the revised product information
Does the submission require a change to the IRB approved consent form? No Yes
If yes, please attach a copy of the current IRB approved consent template with handwritten or electronically tracked changes.
+Sterling IRB will provide only an acknowledgement of receipt for revised product safety information that does not affect the risk to participants (see Question 11 below) and does not require a change to the IRB approved consent form.
Section 4. Study Related / Recruitment Materials:
a. Type of Study Materials Being Submitted (Check all that apply and indicate whether each item is a new submission or a revision to a previously approved material):
Diary/Diaries Study Guide(s) Questionnaire Retention Incentive Materials
New Revised New Revised New Revised New Revised
Subject Instructions Study Card(s) Other (Please describe):
New Revised New Revised New Revised
b. Has the material(s) been approved by Sterling IRB for another protocol or site with this sponsor? No *Yes
*If yes, list the IRB ID # for that study/site:
a. Type of Recruitment Materials Being Submitted (Check all that apply and indicate whether each item is a new submission or a revision to a previously approved material):
Print (i.e. newspaper, brochure, flyer, poster) Website/Internet Use Recruitment Letter
New Revised New Revised New Revised
“On Hold” Message 1Screening Script/Questionnaire 2Television/Video Script/Commercial
New Revised New Revised New Revised
2Radio Script/Commercial Press Release Other (Please describe):
New Revised New Revised New Revised
1Please complete and attach a Screening Script Submission Form, located on our website at www.sterlingirb.com under forms.
2It is recommended that scripts are reviewed and approved prior to production of audio/video materials. All recruitment media must be approved
before advertising begins.
b. Does your submission include a reference or link to a website? No *Yes
* If Yes, it is your responsibility to submit any research-related content, including any information which pertains to a study under the review
of Sterling IRB, for review and approval prior to use.
c. Attach a copy of the study material in the form that it will appear Attached
d. Has the material(s) been approved by Sterling IRB for another protocol or site with this sponsor? No *Yes
*If yes, list the IRB ID # for that study/site:
Section 5. Changes to the Informed Consent Document(s):
Correct Typographical / Grammatical Errors Other (Please describe):
Attach a copy of the current IRB approved consent template with handwritten or electronically tracked changes.
Section 6. Other Submission (e.g. enrollment increase, telephone consent request, or change in vulnerable population enrollment):
a. Please describe:
B. SUBMISSION QUESTIONS
7. Enrollment Status: Study Not Started Open Closed8. If the submission requires a revised and/or new consent form, please provide your recommendation for re-consenting of study participants:
All current enrollees Only new enrollees
All current and new enrollees Other (please specify):
Please note: The Sterling Board will make the final determination regarding the re-consent of study participants.
9. Please provide your preference for issuance of new PI/site approvals during the review of this submission, if applicable:
Please hold all new PI/site approvals until the submitted materials receive final IRB approval.
Please proceed with any new PI/site approvals during the review of this submission (Approval for the revised/new materials will be
issued separately following final IRB approval of the items)
10. Does the submission affect the existing compensation schedule for some or all study sites (e.g. due to a change in the number of study
visits)? No Yes
Please note: Updated compensation information may need to be provided from sites prior to issuing approval documents if the number of study visits has been revised.
11. Does the submission affect the risk to participants? No Yes (Please explain):
12. Are you aware of any community attitudes that will be affected by the submission? No Yes (Please explain):
13. Will this submission require translation? No Yes If yes, what language?
Explanation of Modification/Amendment and/or Comments:
C. ADMINISTRATIVE INFORMATION
Name of Submitting Party: / Return Email Address/Fax:Contact Name and Phone Number for IRB Questions About Submission:
APP265 Modifications and Amendments Submission Form Page 3 of 3
Version: 4.8 Effective Date: 01.19.18