IRB Documents

CONTINUING REVIEW APPROVAL
CR00206257
DATE:

22 Jun 2020

TO:

Laura Dunlap

PROTOCOL:

Centers for Disease Control and Prevention, Medication-Assisted
Treatment for Opioid Use Disorders (MAT Study) (Pro00036325)

CONTINUING REVIEW
APPROVAL DATE:
22 Jun 2020
EXPIRATION DATE:

22 Jun 2021

Thank you for providing the information required for Advarra IRB to conduct continuing review of the
protocol and your site.
In addition to the information you provided, the IRB reviewed the current protocol referenced above, the
Consent Form(s) for the study, and other supporting information.
The IRB approved continuation of the above referenced protocol. The IRB determined changes to the
Consent Form(s) were not necessary.
If the study is expected to last beyond the approval period, you must request and receive re-approval prior
to the expiration date noted above. A report to the Board on the status of this study is due prior to the
expiration date or at the time the study closes, whichever is earlier. It is recommended that you submit
status reports at least 4 weeks prior to your expiration date to avoid any additional fees or lapses in approval.
Approved investigators and sites are required to submit to Advarra for review, and await a response prior
to implementing, any amendments or changes in the protocol; advertisements or recruitment materials
("study-related materials"); investigators; or sites (primary and additional).
Approved investigators and sites are required to notify Advarra of the following reportable events,
including, but not limited to: unanticipated problems involving risks to subjects or others; unanticipated
adverse device effects; protocol violations that may affect the subjects’ rights, safety, or well-being and/or
the completeness, accuracy and reliability of the study data; subject death; suspension of enrollment; or
termination of the study.
Please review the IRB Handbook located in the “Reference Materials” section of the Advarra CIRBI™
Platform (www.cirbi.net). A copy of the most recent IRB roster is also available.
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Thank you for continuing to use Advarra IRB to provide oversight for your research project.

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