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.
Schulman (central) IRB sites:
You can access the form via the Schulman website at www.sairb.com. Please contact email@example.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.
- 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.
- I represent Site/Investigator.
- Our site is one of many sites participating in this study.
- I am submitting documentation for a Site/Investigator.
- I am submitting Closure
No action is required on the next screen. Continue with the questions and select “Submit” after the report preview.
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.
Continuing IRB Review
Ongoing research studies must be reviewed by the Institutional Review Board (IRB) at least annually. This review must take place prior to the approval expiration date noted on the original approval letter. Otherwise, patient enrollment must be suspended.
Schulman-approved sites will need to submit a continuing review study status report. Beginning 8 weeks before study expiration, Schulman will contact the Principal Investigator by e-mail at 2 week intervals to remind him/her that continuing review is due. If assistance is needed with the submission, please contact the Schulman Ongoing Review Team at firstname.lastname@example.org or call 513-761-4100.
Local IRB-approved sites should follow specific local IRB guidance. The IDEAS Study Practice Administrator will need to upload the IRB approval letter and informed consent.
For assistance, please contact IDEAS-Regulatory@acr.org.
Each referring physician who meets the criteria must apply and be approved by ACR. It is expected that a practice administrator or coordinator will register the site and include each physician who wishes to participate in the IDEAS Study. The practice will need to determine who will serve as site Principal Investigator, with the usual responsibilities, prior to submitting to the Institutional Review Board (IRB). Although each individual physician must be approved by ACR, physicians located within the same practice only need to obtain IRB approval once on behalf of the practice.
Central IRB – Schulman Associates Institutional Review Board
Submission for New Referring Practices – CLOSED 11MAY2017
If your site has been approved by the Schulman, you will receive an alert via email prompting you to access the consents and approval documentation on their website. You should navigate to the “Schulman eTools” section of the Schulman website and use the email and password you registered with Schulman in order to access the consents and approval documents. The link below contains document access instructions.
- Schulman IRB
- Contact: Maria Stivers – 513.794.5743
- Please see eSubmission instructions (including sample forms) below
Local Institutional Review Boards
Local IRB approval is also acceptable, but any fees would not be covered by the study. For purposes of this study, the referring physicians are considered subjects of research as well as investigators. A consent template provided for submission to the local IRB. The protocol and all supporting materials are listed below.
- Participant Consent
- Patient Brochure
- Referring Physician Consent
- Interpreting Radiologist/Nuclear Medicine Physician Consent
- Case report forms
PLEASE NOTE: If your site is using a local IRB, you must upload the IRB approval letter and the approved consent forms before your site will be allowed to enroll subjects.
Responses to questions often asked by local IRBs can be found on the IDEAS FAQ page here .