TO: IDEAS Study Participating Sites with Local IRB Oversight
Please be advised that the IDEAS Study (ACRIN 7155) has recently amended the protocol and informed consents. Please note that the amendment and informed consents relating to the participant and dementia specialist have been approved by the central IRB, Schulman Institutional Review Board, for use with new participants (or physicians new to the study) and are ready for local IRB review and approval.
Below is a comprehensive list of materials provided for local IRB submission:
• Protocol Amendment 1, dated 9/23/2016
• Summary of changes itemizing the revisions of Amendment 1
• WORD version of the Participant Informed Consent, dated 11/30/2016
• WORD version of the Referring Physician (dementia specialist) informed consent, dated 11/30/2016
• Spanish and English version patient brochure (Please note these were not revised and are included for those sites who may not have previously submitted them to their IRB.)
Please submit the amended protocol to your IRB immediately. Approval and copies of institution-specific informed consent forms will need to be uploaded to the database portal by the IDEAS Study Administrator within 90 days of this notification. Please contact your IRB coordinator for guidance and your IRB’s policies on the type of review and approval. Should you need assistance from the IDEAS Operations Center, please contact IDEAS-Regulatory@acr.org.
The IDEAS-Study Operations Team
IDEAS-Study Protocol- Amendment 1
IDEAS-Study Protocol-Amendment 1: Summary of Changes
IDEAS- Study Referring Physician Consent – Amendment 1
IDEAS-Study Participant Consent – Amendment 1
IDEAS-Study Patient Brochure – English
IDEAS – Study Patient Brochure – Spanish