PROTOCOL SPECIFIC MATERIALS
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

 

DATA FORMS

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:

www.acrin.org/pdrc.aspx [Site Link]

 

 

 

 

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