PROTOCOL SPECIFIC MATERIALS
4701 DATA FORMS Minimize

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]

 

 Print