PROTOCOL SPECIFIC MATERIALS
PROTOCOL 6657 DATA FORMS

 
Forms Revision Notices:
Form Revisions 02-15-10
Form Revisions 05-11-09
Form Revisions 02-03-09
 
Forms Index:
 
Case Report Form Set:
 
DATA FORMS                                                                   Form Completion Instructions     
6657 Core Forms (Used for cases 1-237):
IAa
IBa
M3b
M4b
S1a
 
6657 Extension Forms (used for cases 238-356):
Visit 1: Pre-Registration/ Baseline Visit – Within 4 weeks prior to start of neoadjuvant treatment:
Registration Eligibility Checklist                                A0 Instructions
Mammography Interpretation Form                         N1 Instructions
MRI -1 Baseline/ Pre-Treatment Form                      T1 Instructions
Ultrasound Interpretation Form                               U1 Instructions
MRS- 1 Baseline/ Pretreatment Form                       V1 Instructions
 
Additional Visit (For 30 consented patients ONLY): Within 72 hours Post Baseline and prior to type 1 Chemotherapy:
MRI- 1.1 Additional Baseline/                                  TA Instructions
  Pretreatment Reproducibility Form
MRS- 1.1 Additional Baseline/                                  VA Instructions
  Pretreatment Reproducibility Form
 
Visit 2: MRI/MRS within 20-28 or 48-96 hours post Baseline MRI/MRS:
MRI-2 Treatment Form                                            T2 Instructions
MRS-2 Treatment Form                                           V2 Instructions
 
Visit 3: MRI/MRS after Type 1 Chemotherapy:
MRI-3 Inter-Regimen Treatment Form                 T3 Instructions
MRS-3 Inter-Regimen Treatment Form                    V3 Instructions
 
Visit 4: Within 3-4 weeks after final Chemotherapy treatment and 1-2 weeks prior to Surgery:
Mammography Interpretation Form                       N4 Instructions
MRI-4 Pre-Surgery Form                                         T4 Instructions
Ultrasound Interpretation From                             U4 Instructions
MRS-4 Pre-Surgery Form                                        V4 Instructions
Surgical Pathology Form (Post- Surgery)                S4 Instructions
 
Supplemental MRI form: Continued reporting of lesions not seen on Baseline (MRI-1):
TS     Supplemental MRI Form                                         TS Instructions
 
End of Study:
End of Study Form                                                 DS Instructions
 
Additional Forms:                                              
Adverse Events                                                     AE Instructions      
Protocol Variation Form                                         PR Instructions
  General Communication Memo

 

 

          For additional information regarding Adverse Events,
please visit ACRIN’s Protocol Development and Regulatory Resources page: