Protocol Activation and Site Application
Site Memos Imaging Materials Recruitment and Educational Materials 4701 Participating Sites 4701 Contact Personnel Regulatory Resources Page Link Protocol Development & Regulatory Resources
Forms Revision Notice: Forms Revision Notice 05-03-2012 Forms Revision Notice 03-09-2012 Forms Revision Notice 02-29-2012
Forms Revision Notice 02-01-2012 Forms Revision Notice_____ 12-15-2011 Forms Revision Notice_____ 12-05-2011 Forms Revision Notice_____ 12-02-2011 Forms Revision Notice_____ 10-12-2011 Forms Revision Notice_____ 09-16-2011 Forms Revision Notice_____ 08-23-2011 Forms Revision Notice_____ 06-16-2011 Forms Revision Notice _____05-12-2011
Forms Index:
Forms Index
DATA FORMS Instructions
General Form Instructions
Registration/Randomization Forms:
A0 Registration/Randomization Assignment A0 Instructions (For use with Amendment 1 approval ONLY) Participant Contact Sheet Form: MR-Authorization to Release/Disclose Medical Records Template (Amendment 1) [DOC] (To be completed by participant at time of consent for sites using ACRIN for medical record procurement. Please forward along with the PC "Participant Contact Information Sheet" to ACRIN Data Management at 215-940-8922. This form provides ACRIN authorization for medical chart procurement) PC-Participant Contact Information PC Instructions
(to be completed by all participants at time of consent: Foreign sites are not participating in the Quality of Life [QoL] sub-study and will maintain it on site only. VA sites will use this form as a worksheet and will maintain it on site only. All other US domestic sites, upon registration, should forward this form to: 1) ACRIN Data Management to allow identification for medical chart procurement requests and 2) Brown University for use in the QoL sub-study at 12 months)
Visit 1:
CR Cardiac Risk and Comorbidity Factors CR Instructions
EK ECG Interpretation EK Instructions
HS Participant Health Survey HS Instructions HS (Spanish Version - Enter in English) LS Lifestyle Form (Baseline / 12 month) LS Instructions LS (Spanish Version - Enter in English)
SA Seattle Angina Questionnaire SA Instructions SA (Spanish Version - Enter in English)
SPECT Arm:
TS SPECT Technical Assessment Form TS Instructions
SP SPECT MPI Diagnostic Imaging Form SP Instructions
CCTA Arm:
CT Coronary CT Angiogram Detailed Form CT Instructions
TC CCTA Technical Assessment Form TC Instructions
Image Transmittal Worksheets (ITWs):
CCTA ITW SPECT MPI ITW Triggered:
I2 Alternative Imaging Form I2 Instructions I3 Additional Imaging Form I3 Instructions
MA MACE Incident Form MA Instructions
Additional Forms:
AE Adverse Events Form AE Instructions CM General Communication Memo CM Instructions PR Protocol Variation Form PR Instructions SR Serious Adverse Event Form SR Instructions OF Off-Study OF Instructions Follow-Up Visit: F1 Follow-up Form (TBD) LS Lifestyle Form (Baseline / 12 month)
For additional information regarding Adverse Events, please visit ACRIN’s Protocol Development and Regulatory Resources page: www.acrin.org/pdrc.aspx [Site Link]