IDEAS-Study – Site IRB Closeout Guidance

  • in news
  • by
  • June 7, 2017
  • Comments Off on IDEAS-Study – Site IRB Closeout Guidance

TO:  IDEAS Study Referring Practices

As you are aware, the study closed to enrollment on December 6, 2017 with the final PET scans to be conducted by mid-January and all PET assessments/interpretations to be submitted 7 days later.  ACRIN 7155 IDEAS Study will close to data submission on January 31, 2018.

Please submit a final closure report to the institutional review board (IRB) providing oversight for the research.  A final closure report should be submitted once all protocol related activities are completed and all data have been submitted.  If your IRB approval expires without a report submitted, such action may be considered non-compliance and could affect your involvement in future research.

For Schulman (central) IRB sites:

You can access the form via the Schulman website at www.sairb.com.  Please contact ongoingreview@sairb.com or 513-761-4100 should you have questions.   Here is some helpful information for completing the online form.

The IRB # for your site is in the top right hand corner of the informed consent document. The protocol # for your site is ACRIN 7155 IDEAS. The sponsor for your site is American College of Radiology Imaging Network. 

From the website: www.sairb.com

  • Login to Schulman eTools. This is located in the upper right hand corner
  • Sign on with your email and password or register for an account.
  • Select Start a New Form in the Purple square under Submissions.
  • Select Study Status Reporting.
  1. I represent Site/Investigator.
  2. Our site is one of many sites participating in this study.
  3. I am submitting documentation for a Site/Investigator.
  4. I am submitting Closure

No action is required on the next screen.  Continue with the questions and select “Submit” after the report preview.

 

For Local IRB Sites:

Please note that the sponsor, ACR, will require a copy of your IRB study closure approval letter. The practice administrator will have access to the IDEAS database to upload the study closure approval letter until February 15, 2018.   Please contact IDEAS-Regulatory@acr.org  or Alexis Dickens at 215-574-3169 should you have any questions.

 

Sincerely,

 

Alexis Dickens and Cynthia Olson

IDEAS Study Operations Center American College of Radiology
1818 Market St., Suite 1720 | Philadelphia, PA 19103 |
IDEAS-Study@acr.org
IDEAS-Regulatory@acr.org

Comments are closed.