6684 DATA FORMS Minimize

Forms Revisions Notices:
Form Revision Notice MH                  08-20-2012
Form Revision Notice ITW                08-06-2012
Form Revision Notice F1                   06-01-2012    

Form Revision Notice A0, AT, BS, EX, F1, MR, SA, T4, TA, V1, VA       01-07-2011

Form Revision Notice MR, F1            09-21-2010

Form Revision Notice BS                   09-13-2010

Form Revision Notice A0, V3, AT      07-27-2010

Form Revision Notice V1                   06-29-2010

Form Revision Notice V4, OI, AI, T4 06-23-2010

Form Revision Notice TA, T4             05-07-2010

Form Revision Notice BS, TA             03-25-2010

Form Revision Notice V1,V2, MR       03-04-2010



Forms Index:                                                                 General Forms Completion Instructions

6684 Index                                                                               General Completion Instructions




Visit 1 (Registration/Eligibility):


A0   Registration/ Eligibility Checklist 


V1    Visit 1 Evaluation Form 

V1 Instructions

TX    Prior Therapies Form                                          

TX Instructions



Visit 2 (Within 14 Days prior to tx):  


V2    Visit 2 Evaluation Form


MH    Baseline Abnormalities Form                                       

MH Instructions

EX    FMISO Administration Form


TA     FMISO PET/CT Technical Assessment Form                    

TA Instructions

BS     FMISO Blood Sampling Form


SA     FMISO Safety Assessment Form


MR    MRI/MRS Form




Visit 2a (1st 15 participants only within 7 days of V2, prior to tx): 


VA    Visit 2 Evaluation Form

 VA Instructions

MH   Baseline Abnormalities Form

 MH Instructions

EX    FMISO Administration Form


TA    FMISO PET/CT Technical Assessment Form

 TA Instructions

BS   FMISO Blood Sampling Form


SA    FMISO Safety Assessment Form




Follow- Up (every 3 months for up to 5 years -post V2): 


F1  Follow up Form                                                                                            

 F1 Instructions



Tumor Analysis:


Hypoxic Markers Analysis Form




Tissue Transmittal:


TT    Tissue Transmittal Form




End of Study:


DS    End of Study Form




Additional Forms:


OI  Off Imaging Form


PR  Protocol Variation Form


AE   Adverse Event Form


CO  Concomitant Medications Form                                                                   

 CO Instructions

CO  Supplemental Concomitant Medications Form


RE   Comments/Remarks Form


AI    Additional Imaging Form


AI    Supplemental Additional Imaging Form


AT    Additional Treatment Form


AT  Supplemental Additional Treatment Form


T4   Protocol Treatment Interruptions Form 


T4   Supplemental Protocol Treatment Interruptions Form 


MH  Supplemental Abnormalities Form

 MH Instructions



General Communication Memo


CM   Communication Memo

ACRIN Adverse Event (AE) Log


For additional information regarding Adverse Events,

please visit ACRIN’s Protocol Development and Regulatory Resources page: [Site Link]