Case Report Forms
MODULE B: Case Report Forms
Jane Fendl & Denise Thwing
April 7, 2010
www.nihtraining.com/cc/ippcr/current/.../Mailhot020706.ppt
1
Version: Final 07-Apr-2010
1
Case Report Form
CRF
Official clinical data-recording document or tool used in a clinical study
RDC/RDE (Remote Data Capture,
Remote Data Entry)
PAPER
2
Version: Final 07-Apr-2010
2
The Case Report Form is a data-reporting document used in a clinical study. Its purpose is to collect the study data in a specific format that allows for efficient analysis.
Data from clinical trials is also collected using computerized Case Report Forms. This is referred to as Remote Site Monitoring (RSM) or Remote Data Entry (RDE). If RSM/RDE is utilized, data is generally entered onto paper workbooks, then input on computer screens which mimic the format of a paper CRF. Data can then be electronically transferred to Pfizer.
Purpose
Collects relevant data in a specific format
in accordance with the protocol
compliance and with regulatory requirements
Allows for efficient and complete data processing, analysis and reporting
Facilitates the exchange of data across projects and organizations esp. through standardization
3
Version: Final 07-Apr-2010
3
CRF Relationship to Protocol
Protocol determines what data should be collected on the CRF
All data must be collected on the CRF if specified in the protocol
Data that will not be analyzed should not appear on the CRF
4
Version: Final 07-Apr-2010
4
CRF Development
Guidelines
Collect data with all users in mind
Collect data required by the regulatory agencies
Collect data outlined in the protocol
Be clear and concise with your data questions
Avoid duplication
Request minimal free text responses
Provide units to ensure comparable values
Provide instructions to reduce misinterpretations
5
Version: Final 07-Apr-2010
5
CRF Development
Guidelines (cont)
Provide choices for each questions
allows for computer summarization
Use None and Not done
Collect data in a fashion that:
allows for the most efficient computerization
similar data to be collected across studies
CRF book needs to be finalized and available before an investigator starts enrolling patients into a study
Take the time to get it right the first time
6
Version: Final 07-Apr-2010
6
Elements of the CRF
Three major parts:
Header
Safety related modules
Efficacy related modules
7
Version: Final 07-Apr-2010
7
The term CRF indicates a single CRF page. A series of CRF pages makes up a CRF Book, and one CRF book is completed for each subject enrolled in a study.
Header Information
Key identifying Information
MUST HAVES
Study Number
Site/Center Number
Subject identification number
8
Version: Final 07-Apr-2010
8
Creating Safety Modules
Usually come from a standard library
Select modules appropriate for your study
Keep safety analysis requirements in mind
Safety Modules usually include
Demographic
Adverse Events
Vital Signs
Medical History/Physical Exam
Concomitant Medications
Patient Disposition
9
Version: Final 07-Apr-2010
9
Efficacy Modules
Designed for each therapeutic area based on the protocol
Considered to be unique modules and can be more difficult to develop
Use existing examples from similar protocols where applicable
Consider developing a library of efficacy pages
Design modules following project standards for data collection
10
Version: Final 07-Apr-2010
10
Creating Efficacy Modules
Follow general CRF design guidelines
Use pages or modules from the therapeutic library
Define diagnostics required
Include appropriate baseline measurements
Repeat same battery of tests
Define and identify
key efficacy endpoints
additional tests for efficacy
11
Version: Final 07-Apr-2010
11
Importance of Standard CRFs
Prepares the way for data exchange
Removes the need for mapping during data exchange
Allows for consistent reporting across protocols, across projects
Promotes monitoring and investigator staff efficiency
Allows merging of data between studies
Provides increased efficiency in processing and analysis of clinical data
12
Version: Final 07-Apr-2010
12
CRF Development Process
CRF Designer
Reviewers
CRF Designer
CRF Book
Drafts CRF from protocol
CRF Review Meeting
Comments back to designer
Updates CRF to incl. comments
Review and Sign off
Coordinate printing and distribution
Site
13
Version: Final 07-Apr-2010
13
The slide shows an overview of the CRF development process.
One of the first decision points is to determine which CRA Book format to use. There are two types of formats; one format is designed to retrieve data upon treatment completion (log form), and the other is designed to retrieve data on a visit-by-visit basis.
To help with the design, you can access Pfizers library of standard CRF pages for collecting safety and demographic data. You can select a template that is appropriate to the needs of the study. Using a template facilitates the assembly of the CRF.
With appropriate approval from your group, you may make changes or edits to the safety templates to meet the specific needs of the study.
Date requests on the CRF pages which collect efficacy or, for Phase I studies, pharmacokinetic or pharmacodynamic data must parallel the protocol.
After drafting any new or unique efficacy or pharmacokinetic/pharmacodynamic pages, it is a good idea to send them to one or two sites that will be conducting the study and ask the site personnel for feedback.
CRF Development Process
Responsibility for CRF design can vary between clinical research organizations (CRA, data manager, specialty role)
Include all efficacy and safety parameters specified in the protocol using standards libraries
To collect ONLY data required by the protocol
Work with protocol grid/visit schedule
14
Version: Final 07-Apr-2010
14
The CRA is responsible for designing the CRF Book to parallel the efficacy and safety parameters indicated in the protocol.
CRF Development Process
Interdisciplinary review is necessary
each organization has its own process for review/sign-off
Should include relevant members of the project team involved in conduct, analysis and reporting of the trial
Begins
As soon in the study prep process as possible
15
Version: Final 07-Apr-2010
15
The CRA is responsible for designing the CRF Book to parallel the efficacy and safety parameters indicated in the protocol.
CRF Development Process
Review Team (example)
Project Clinician
Lead CRA
Lead Statistician
Lead Programmer
Lead Data Manager
Others
Database Development, Dictionary Coding, Standards
16
Version: Final 07-Apr-2010
16
CRF development should begin as soon as possible in the study preparation process. However, some CRF pages, such as those relating to efficacy or pharmacokinetics and pharmacodynamics, cannot be finalized until the final protocol has been completed.
Draft CRFs are usually reviewed by the clinician, statistician and group leader. There also may be a CRF Review Committee that includes clinical staff as well as Data Management personnel.
CRF Development Process
After the CRF book is approved
Initiate the process for printing
Note: the Protocol must be approved before the CRF book is approved and printed
After it is printed
Stored according to organizational guidelines
Printed and distributed to research sites
17
Version: Final 07-Apr-2010
17
After the CRF Book has been approved, the process for printing the document is initiated. The completion of this process will vary. After the CRFs have been finalized and printed, a copy of the CRF Book is sent to: Central Files (CRF Librarian), Statistician, Data Coordination Group.
Properly Designed CRF
Components/All of the CRF pages are reusable
Saves time
Saves money
+
18
Version: Final 07-Apr-2010
18
Poorly Designed CRF
Data not collected
Database may require modification
Data Entry process impeded
Need to edit data
Target dates are missed
Collected too much data Wasted resources in collection and processing
19
Version: Final 07-Apr-2010
19
Poorly Designed CRF Issues
=
20
Version: Final 07-Apr-2010
20
The Case Report Form
How do we use it?
Collect data from the investigational sites
Helps project team and study site team
Reminder to investigator to perform specific evaluation
CRA uses to verify protocol is being followed and compare with source documents
Biometrics uses it to build database structures, develop edit checks and programming specs
21
Version: Final 07-Apr-2010
21
The CRA and Clinician will monitor the data recorded on the CRFs. Although the purpose of the CRF is to collect data, it also helps the study site team and you perform your jobs.
The CRF acts as a reminder to the investigator to perform specific evaluations and you can use the CRF to verify that the protocol is being followed (i,e, correct evaluations are being conducted at the appropriate time) and subject safety is being maintained.
The Case Report Form
Used for:
Subject tracking
Data analysis and reporting
Reports to FDA on subject safety
Promotional materials
New Drug Application submissions
Support of labeling claims
Articles in medical journals
22
Version: Final 07-Apr-2010
22
CRFs collect all subject data required by the protocol and are used for subject tracking and data analysis. The data that is collected is very important, because it is the basis for making decisions about the drug, its benefits, risks, and potential marketability.
Biometricians/Statisticians and Data Management personnel analyze and report the data recorded on the CRFs in the final study reports for the clinical trial. This data is used for reports to the FDA on subject safety (e.g. serious adverse events, annual progress reports, is included in promotional materials and is submitted in NDAs.
Additionally, the data from the clinical trial may be used to support labeling claims for the drug or may be published in medical journals. So it is critical that the data be accurate and completes
Electronic CRFs
The use of RDC is increasing
In general, the concepts for the design of electronic CRFs/RDC screens are the same as covered for paper
Electronic CRFs will impact the following:
Review of CRF is different (screen review)
No need to print and distribute paper
23
Version: Final 07-Apr-2010
23
24
Version: Final 07-Apr-2010
24
Version: Final 07-Apr-2010
25
25
26
Version: Final 07-Apr-2010
26
27
Version: Final 07-Apr-2010
27
28
Version: Final 07-Apr-2010
28
Version: Final 07-Apr-2010
29
29
30
Version: Final 07-Apr-2010
30
31
Version: Final 07-Apr-2010
31
Version: Final 07-Apr-2010
32
32
33
Version: Final 07-Apr-2010
33
34
Version: Final 07-Apr-2010
34
35
Version: Final 07-Apr-2010
35
36
Version: Final 07-Apr-2010
36
Questions ?
37
Version: Final 07-Apr-2010
37
IND Study #______ Eligibility Checklist Pg 1 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Instructions: Check the appropriate box for each Inclusion and Exclusion Criterion below. Each criterion must bemarked and all protocol criteria have to be met prior to enrolling the subject.
Inclusion CriteriaEach criterion must be addressed and documented in the subject's medical record or source.
Y N NA
1. The diagnosis of __________ should be established by _______. In case of participation of other sub-sites in the study, pathology slides and blocks should be submitted for centralreview at the UAMS Pathology Laboratory. However, enrollment may proceed based on the results of the local review of this material.
2. Subjects should have normal serum BUN and Creatinine levels based on institutional norms at screening.
3. Subjects should have normal LVEF evaluated by MUGA scan 45% at screening.
4. Female age > 18
5. Good performance status defined by ECOG scale of 0 or 1 (Appendix F).
6. Written consent.
7. Women of childbearing potential must have a negative pregnancy test.
8. Use of effective means of contraception in subjects of child-bearing potential while on treatment and for at least 3 months thereafter.
9. Peripheral neuropathy: must be < grade 1
10. Hematologic (minimal values)Absolute neutrophil count > 1,500/mm3
Hemoglobin > 8.0 g/dlPlatelet count > 100,000/mm3
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Eligibility Checklist Pg 2 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Y N NA
11. HepaticTotal Bilirubin < ULN
AST and ALT and Alkaline Phosphatase must be within the range allowing foreligibility. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used.
AST or ALT:ALK PHOS: < ULN > 1X BUT 1.5X BUT 5X ULN
< ULN Eligible Eligible Eligible Ineligible>1x but 2.5x but 5x ULN Ineligible Ineligible Ineligible Ineligible
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Eligibility Checklist Pg 3 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Exclusion CriteriaEach criterion must be addressed and documented in the subject's medical record.
Y N NAa. Disease-Specific Concerns1. Subjects who have _________________ will be excludedfrom this study due to the risk of worsening ulcers and healing difficulties
2. Stage ______ cancer
3. Inflammatory cancer
b. General Medical Concerns1. Subjects with ECOG performance status 2, 3, and 4 are not eligible for this study
2. Allergy to any component of the treatment regimen
3. Refusal to use effective contraception while participating in this study
4. Inability to comply with study and/or follow-up procedures
5. Subjects with secondary malignancy other than superficial skin cancer (squamous cell carcinoma and basal cell carcinoma of the skin) should be excluded
c. Study Drug - Specific Concerns1. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
2. Blood pressure of > 150/100 mmHg. Essential hypertension well controlled with antihypertensive is not an exclusion criterion.
3. Unstable angina
4. New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix D)
5. History of myocardial infarction within 6 months
6. History of stroke within 6 months
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Eligibility Checklist Pg 4 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Y N NA
7. Clinically significant peripheral vascular disease
8. Evidence of bleeding diathesis or coagulopathy
9. Presence of central nervous system or brain metastases
10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
11. Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
12. Pregnant (positive pregnancy test) or breast feeding
13. Urine protein: creatinine ratio >1.0 at screening
14. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
15. Serious, non-healing wound, ulcer, or bone fracture
Subject meets all eligibility criteria
If the subject did not meet all eligibility criteria, was a waiver granted by the medical monitor
Date:Signature of Principal Investigator Day Month Year
Date:Completed by Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Demographics Pg 5 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of Birth:Day Month Year
Race: White(Mark all
which apply) Black or African American
Native Hawaiian or other Pacific Islander
Asian
American Indian or Alaska Native
Unknown
Ethnicity: Hispanic or Latino(Mark only 1)
Non-Hispanic
Unknown
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Disease History Pg 6 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of initial diagnosis of ___________Day Month Year
if NDReceptor Analyses: Estrogen Positive Negative
Progesterone Positive Negative
HER2 Analyses: IHC Positive Negative
FISH Positive Negative
Staging
Primary tumor T1 T2 T3 T4
Lymph Node NX N0 N1 N2 N3
Metastasis MX M0 M1
Menopausal Status ( one):
Pre (< 6 mo since LMP and no prior bilateral ovariectomy and not on estrogen replacement)*If , a urine pregnancy test is required
Post (prior bilateral ovariectomy OR > 12 mo since LMP and no prior hysterectomy)
Above not applicable AND age < 50 (pre) Above not applicable AND age > 50 (post)
Name of Biopsy
Was _____ node sampling performed? Yes No
_______ Biopsy Date:Day Month Year
_______ Biopsy Results: Positive Negative
Number of ______ Examined: Number of ________ Positive:
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Medical History Pg 7 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Record pertinent medical and/or surgerical history in the space provided below
System Normal Abnormal List Diagnosis and Date
Head/Ears/Eyes/Nose/Throat
Respiratory
Cardiovascular
Gastrointestinal
Hepatic/GallBladder
Renal
Genitourinary
Musculoskeletal
Dermatological
Nervous System
Hematological
Lymphatic
Endocrine
Psychological/Psychiatric
Other _________________
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Radiology Pg 8 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Local/Regional
if NDDay Month Year Normal Metastatic
Chest X-ray
CT Brainand/or
MRI Brain
CT Chestand/or
MRI Chest
CT Abdomenand/or
MRI Abdomen
Bone Scan
PET CT
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ EKG Pg 9 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of ECG:Day Month Year
Overall interpretation: Normal
Clinically insignificant abnormality
Clinically significant abnormality (specify)
1
2
3
4
5
6
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Ancillary Exams Pg 10 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of Mammogram:Day Month Year
Normal
Abnormal
Birad: 0 1 2 3 4 5 6
Date of MUGA:Day Month Year
LVEF %
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Physical Exam Pg 11 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
WNL ABN if ND
Comment if Abnormal
General
HEENT
Chest Wall
Pulmonary
Abdomen
Musculoskeletal
Extremities
Neurological
Skin
Lymphatic
Psych
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Tumor Assessment (COR) Pg 12 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Target Lesion Measurement
Tumor laterality ( one) Left RightProduct
Site Horizontal Vertical (cm). x . .
if Not Applicable . x . .
if Not Applicable . x . .
Product of all target lesions .
Site codes: UOQ=Upper Outer Quadrant, LOQ=Lower Outer Quadrant, UIQ=Upper Inner Quadrant, LIQ=Lower Inner Quadrant, CEN=Centrally Located
Regional Nodes
Does the subject have involvement of the regional nodes/axilla? Yes complete below No
Non-palpable?
ProductSite Palpable? Measurable? Horizontal Vertical (cm)
. x . .
Product of all target lesions .
Site codes: RAX=Right Axilla, LAX=Left Axilla, RSC=Right Supraclavicular, LSC=Left Supraclavicular
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Vital Signs Pg 13 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Exam Date:Day Month Year
Height: . cm In
Weight: . kg lbs
Blood Pressure:
Pulse: minute
Temperature: . C F
Respirations: minute
Performance Status:
0 1 2
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Laboratory Pg 14 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Specimen Collection Date:
if ND
Day Month Year if ND
WBC (K/L) . Neutrophils (%) .
Absolute Neutrophil Count Total bilirubin (mg/dL) .
Platelets (K/L) LDH (IU/L)
RBC (M/L) . Alk. phos. (IU/L)
Hemoglobin (g/dL) . SGOT/AST (IU/L)
BUN (mg/dL) SGPT/ALT (IU/L)
Creatinine (mg/dL) . GGT (IU/L)
Sodium (mEq/L) PT (sec) .
Potassium (mEq/L) . PTT (sec) .
CO2 (mEq/L) INR .
Chloride (mEq/L)
Assay Collection if ND
_____________ :Day Month Year H H M M
_____________ :Day Month Year H H M M
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Urine Analysis Pg 15 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Specimen Collection Date:Day Month Year
UPC if ND
Protein (mg/dL)
Creatinine (mg/dL) .
Protein / Creatinine ratio .
Urine Pregnancy Test
Date of Urine Pregnancy Test: or if NADay Month Year
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
Screening
IND Study #______ Eligibility Checklist Pg 1 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Instructions: Check the appropriate box for each Inclusion and Exclusion Criterion below. Each criterion must bemarked and all protocol criteria have to be met prior to enrolling the subject.
Inclusion CriteriaEach criterion must be addressed and documented in the subject's medical record or source.
Y N NA
1. The diagnosis of __________ should be established by _______. In case of participation of other sub-sites in the study, pathology slides and blocks should be submitted for centralreview at the UAMS Pathology Laboratory. However, enrollment may proceed based on the results of the local review of this material.
2. Subjects should have normal serum BUN and Creatinine levels based on institutional norms at screening.
3. Subjects should have normal LVEF evaluated by MUGA scan 45% at screening.
4. Female age > 18
5. Good performance status defined by ECOG scale of 0 or 1 (Appendix F).
6. Written consent.
7. Women of childbearing potential must have a negative pregnancy test.
8. Use of effective means of contraception in subjects of child-bearing potential while on treatment and for at least 3 months thereafter.
9. Peripheral neuropathy: must be < grade 1
10. Hematologic (minimal values)Absolute neutrophil count > 1,500/mm3
Hemoglobin > 8.0 g/dlPlatelet count > 100,000/mm3
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Eligibility Checklist Pg 2 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Y N NA
11. HepaticTotal Bilirubin < ULN
AST and ALT and Alkaline Phosphatase must be within the range allowing foreligibility. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used.
AST or ALT:ALK PHOS: < ULN > 1X BUT 1.5X BUT 5X ULN
< ULN Eligible Eligible Eligible Ineligible>1x but 2.5x but 5x ULN Ineligible Ineligible Ineligible Ineligible
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Eligibility Checklist Pg 3 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Exclusion CriteriaEach criterion must be addressed and documented in the subject's medical record.
Y N NAa. Disease-Specific Concerns1. Subjects who have _________________ will be excludedfrom this study due to the risk of worsening ulcers and healing difficulties
2. Stage ______ cancer
3. Inflammatory cancer
b. General Medical Concerns1. Subjects with ECOG performance status 2, 3, and 4 are not eligible for this study
2. Allergy to any component of the treatment regimen
3. Refusal to use effective contraception while participating in this study
4. Inability to comply with study and/or follow-up procedures
5. Subjects with secondary malignancy other than superficial skin cancer (squamous cell carcinoma and basal cell carcinoma of the skin) should be excluded
c. Study Drug - Specific Concerns1. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
2. Blood pressure of > 150/100 mmHg. Essential hypertension well controlled with antihypertensive is not an exclusion criterion.
3. Unstable angina
4. New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix D)
5. History of myocardial infarction within 6 months
6. History of stroke within 6 months
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Eligibility Checklist Pg 4 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Y N NA
7. Clinically significant peripheral vascular disease
8. Evidence of bleeding diathesis or coagulopathy
9. Presence of central nervous system or brain metastases
10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
11. Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
12. Pregnant (positive pregnancy test) or breast feeding
13. Urine protein: creatinine ratio >1.0 at screening
14. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
15. Serious, non-healing wound, ulcer, or bone fracture
Subject meets all eligibility criteria
If the subject did not meet all eligibility criteria, was a waiver granted by the medical monitor
Date:Signature of Principal Investigator Day Month Year
Date:Completed by Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Demographics Pg 5 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of Birth:Day Month Year
Race: White(Mark all
which apply) Black or African American
Native Hawaiian or other Pacific Islander
Asian
American Indian or Alaska Native
Unknown
Ethnicity: Hispanic or Latino(Mark only 1)
Non-Hispanic
Unknown
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Disease History Pg 6 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of initial diagnosis of ___________Day Month Year
if NDReceptor Analyses: Estrogen Positive Negative
Progesterone Positive Negative
HER2 Analyses: IHC Positive Negative
FISH Positive Negative
Staging
Primary tumor T1 T2 T3 T4
Lymph Node NX N0 N1 N2 N3
Metastasis MX M0 M1
Menopausal Status ( one):
Pre (< 6 mo since LMP and no prior bilateral ovariectomy and not on estrogen replacement)*If , a urine pregnancy test is required
Post (prior bilateral ovariectomy OR > 12 mo since LMP and no prior hysterectomy)
Above not applicable AND age < 50 (pre) Above not applicable AND age > 50 (post)
Name of Biopsy
Was _____ node sampling performed? Yes No
_______ Biopsy Date:Day Month Year
_______ Biopsy Results: Positive Negative
Number of ______ Examined: Number of ________ Positive:
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Medical History Pg 7 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Record pertinent medical and/or surgerical history in the space provided below
System Normal Abnormal List Diagnosis and Date
Head/Ears/Eyes/Nose/Throat
Respiratory
Cardiovascular
Gastrointestinal
Hepatic/GallBladder
Renal
Genitourinary
Musculoskeletal
Dermatological
Nervous System
Hematological
Lymphatic
Endocrine
Psychological/Psychiatric
Other _________________
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Radiology Pg 8 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Local/Regional
if NDDay Month Year Normal Metastatic
Chest X-ray
CT Brainand/or
MRI Brain
CT Chestand/or
MRI Chest
CT Abdomenand/or
MRI Abdomen
Bone Scan
PET CT
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ EKG Pg 9 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of ECG:Day Month Year
Overall interpretation: Normal
Clinically insignificant abnormality
Clinically significant abnormality (specify)
1
2
3
4
5
6
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Ancillary Exams Pg 10 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of Mammogram:Day Month Year
Normal
Abnormal
Birad: 0 1 2 3 4 5 6
Date of MUGA:Day Month Year
LVEF %
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Physical Exam Pg 11 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
WNL ABN if ND
Comment if Abnormal
General
HEENT
Chest Wall
Pulmonary
Abdomen
Musculoskeletal
Extremities
Neurological
Skin
Lymphatic
Psych
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Tumor Assessment (COR) Pg 12 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Target Lesion Measurement
Tumor laterality ( one) Left RightProduct
Site Horizontal Vertical (cm). x . .
if Not Applicable . x . .
if Not Applicable . x . .
Product of all target lesions .
Site codes: UOQ=Upper Outer Quadrant, LOQ=Lower Outer Quadrant, UIQ=Upper Inner Quadrant, LIQ=Lower Inner Quadrant, CEN=Centrally Located
Regional Nodes
Does the subject have involvement of the regional nodes/axilla? Yes complete below No
Non-palpable?
ProductSite Palpable? Measurable? Horizontal Vertical (cm)
. x . .
Product of all target lesions .
Site codes: RAX=Right Axilla, LAX=Left Axilla, RSC=Right Supraclavicular, LSC=Left Supraclavicular
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Vital Signs Pg 13 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Exam Date:Day Month Year
Height: . cm In
Weight: . kg lbs
Blood Pressure:
Pulse: minute
Temperature: . C F
Respirations: minute
Performance Status:
0 1 2
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Laboratory Pg 14 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Specimen Collection Date:
if ND
Day Month Year if ND
WBC (K/L) . Neutrophils (%) .
Absolute Neutrophil Count Total bilirubin (mg/dL) .
Platelets (K/L) LDH (IU/L)
RBC (M/L) . Alk. phos. (IU/L)
Hemoglobin (g/dL) . SGOT/AST (IU/L)
BUN (mg/dL) SGPT/ALT (IU/L)
Creatinine (mg/dL) . GGT (IU/L)
Sodium (mEq/L) PT (sec) .
Potassium (mEq/L) . PTT (sec) .
CO2 (mEq/L) INR .
Chloride (mEq/L)
Assay Collection if ND
_____________ :Day Month Year H H M M
_____________ :Day Month Year H H M M
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Urine Analysis Pg 15 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Specimen Collection Date:Day Month Year
UPC if ND
Protein (mg/dL)
Creatinine (mg/dL) .
Protein / Creatinine ratio .
Urine Pregnancy Test
Date of Urine Pregnancy Test: or if NADay Month Year
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
Screening
IND Study #______ Eligibility Checklist Pg 1 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Instructions: Check the appropriate box for each Inclusion and Exclusion Criterion below. Each criterion must bemarked and all protocol criteria have to be met prior to enrolling the subject.
Inclusion CriteriaEach criterion must be addressed and documented in the subject's medical record or source.
Y N NA
1. The diagnosis of __________ should be established by _______. In case of participation of other sub-sites in the study, pathology slides and blocks should be submitted for centralreview at the UAMS Pathology Laboratory. However, enrollment may proceed based on the results of the local review of this material.
2. Subjects should have normal serum BUN and Creatinine levels based on institutional norms at screening.
3. Subjects should have normal LVEF evaluated by MUGA scan 45% at screening.
4. Female age > 18
5. Good performance status defined by ECOG scale of 0 or 1 (Appendix F).
6. Written consent.
7. Women of childbearing potential must have a negative pregnancy test.
8. Use of effective means of contraception in subjects of child-bearing potential while on treatment and for at least 3 months thereafter.
9. Peripheral neuropathy: must be < grade 1
10. Hematologic (minimal values)Absolute neutrophil count > 1,500/mm3
Hemoglobin > 8.0 g/dlPlatelet count > 100,000/mm3
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Eligibility Checklist Pg 2 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Y N NA
11. HepaticTotal Bilirubin < ULN
AST and ALT and Alkaline Phosphatase must be within the range allowing foreligibility. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used.
AST or ALT:ALK PHOS: < ULN > 1X BUT 1.5X BUT 5X ULN
< ULN Eligible Eligible Eligible Ineligible>1x but 2.5x but 5x ULN Ineligible Ineligible Ineligible Ineligible
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Eligibility Checklist Pg 3 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Exclusion CriteriaEach criterion must be addressed and documented in the subject's medical record.
Y N NAa. Disease-Specific Concerns1. Subjects who have _________________ will be excludedfrom this study due to the risk of worsening ulcers and healing difficulties
2. Stage ______ cancer
3. Inflammatory cancer
b. General Medical Concerns1. Subjects with ECOG performance status 2, 3, and 4 are not eligible for this study
2. Allergy to any component of the treatment regimen
3. Refusal to use effective contraception while participating in this study
4. Inability to comply with study and/or follow-up procedures
5. Subjects with secondary malignancy other than superficial skin cancer (squamous cell carcinoma and basal cell carcinoma of the skin) should be excluded
c. Study Drug - Specific Concerns1. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
2. Blood pressure of > 150/100 mmHg. Essential hypertension well controlled with antihypertensive is not an exclusion criterion.
3. Unstable angina
4. New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix D)
5. History of myocardial infarction within 6 months
6. History of stroke within 6 months
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Eligibility Checklist Pg 4 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Y N NA
7. Clinically significant peripheral vascular disease
8. Evidence of bleeding diathesis or coagulopathy
9. Presence of central nervous system or brain metastases
10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
11. Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
12. Pregnant (positive pregnancy test) or breast feeding
13. Urine protein: creatinine ratio >1.0 at screening
14. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
15. Serious, non-healing wound, ulcer, or bone fracture
Subject meets all eligibility criteria
If the subject did not meet all eligibility criteria, was a waiver granted by the medical monitor
Date:Signature of Principal Investigator Day Month Year
Date:Completed by Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Demographics Pg 5 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of Birth:Day Month Year
Race: White(Mark all
which apply) Black or African American
Native Hawaiian or other Pacific Islander
Asian
American Indian or Alaska Native
Unknown
Ethnicity: Hispanic or Latino(Mark only 1)
Non-Hispanic
Unknown
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Disease History Pg 6 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of initial diagnosis of ___________Day Month Year
if NDReceptor Analyses: Estrogen Positive Negative
Progesterone Positive Negative
HER2 Analyses: IHC Positive Negative
FISH Positive Negative
Staging
Primary tumor T1 T2 T3 T4
Lymph Node NX N0 N1 N2 N3
Metastasis MX M0 M1
Menopausal Status ( one):
Pre (< 6 mo since LMP and no prior bilateral ovariectomy and not on estrogen replacement)*If , a urine pregnancy test is required
Post (prior bilateral ovariectomy OR > 12 mo since LMP and no prior hysterectomy)
Above not applicable AND age < 50 (pre) Above not applicable AND age > 50 (post)
Name of Biopsy
Was _____ node sampling performed? Yes No
_______ Biopsy Date:Day Month Year
_______ Biopsy Results: Positive Negative
Number of ______ Examined: Number of ________ Positive:
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Medical History Pg 7 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Record pertinent medical and/or surgerical history in the space provided below
System Normal Abnormal List Diagnosis and Date
Head/Ears/Eyes/Nose/Throat
Respiratory
Cardiovascular
Gastrointestinal
Hepatic/GallBladder
Renal
Genitourinary
Musculoskeletal
Dermatological
Nervous System
Hematological
Lymphatic
Endocrine
Psychological/Psychiatric
Other _________________
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Radiology Pg 8 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Local/Regional
if NDDay Month Year Normal Metastatic
Chest X-ray
CT Brainand/or
MRI Brain
CT Chestand/or
MRI Chest
CT Abdomenand/or
MRI Abdomen
Bone Scan
PET CT
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ EKG Pg 9 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of ECG:Day Month Year
Overall interpretation: Normal
Clinically insignificant abnormality
Clinically significant abnormality (specify)
1
2
3
4
5
6
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Ancillary Exams Pg 10 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of Mammogram:Day Month Year
Normal
Abnormal
Birad: 0 1 2 3 4 5 6
Date of MUGA:Day Month Year
LVEF %
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Physical Exam Pg 11 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
WNL ABN if ND
Comment if Abnormal
General
HEENT
Chest Wall
Pulmonary
Abdomen
Musculoskeletal
Extremities
Neurological
Skin
Lymphatic
Psych
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Tumor Assessment (COR) Pg 12 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Target Lesion Measurement
Tumor laterality ( one) Left RightProduct
Site Horizontal Vertical (cm). x . .
if Not Applicable . x . .
if Not Applicable . x . .
Product of all target lesions .
Site codes: UOQ=Upper Outer Quadrant, LOQ=Lower Outer Quadrant, UIQ=Upper Inner Quadrant, LIQ=Lower Inner Quadrant, CEN=Centrally Located
Regional Nodes
Does the subject have involvement of the regional nodes/axilla? Yes complete below No
Non-palpable?
ProductSite Palpable? Measurable? Horizontal Vertical (cm)
. x . .
Product of all target lesions .
Site codes: RAX=Right Axilla, LAX=Left Axilla, RSC=Right Supraclavicular, LSC=Left Supraclavicular
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Vital Signs Pg 13 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Exam Date:Day Month Year
Height: . cm In
Weight: . kg lbs
Blood Pressure:
Pulse: minute
Temperature: . C F
Respirations: minute
Performance Status:
0 1 2
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Laboratory Pg 14 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Specimen Collection Date:
if ND
Day Month Year if ND
WBC (K/L) . Neutrophils (%) .
Absolute Neutrophil Count Total bilirubin (mg/dL) .
Platelets (K/L) LDH (IU/L)
RBC (M/L) . Alk. phos. (IU/L)
Hemoglobin (g/dL) . SGOT/AST (IU/L)
BUN (mg/dL) SGPT/ALT (IU/L)
Creatinine (mg/dL) . GGT (IU/L)
Sodium (mEq/L) PT (sec) .
Potassium (mEq/L) . PTT (sec) .
CO2 (mEq/L) INR .
Chloride (mEq/L)
Assay Collection if ND
_____________ :Day Month Year H H M M
_____________ :Day Month Year H H M M
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Urine Analysis Pg 15 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Specimen Collection Date:Day Month Year
UPC if ND
Protein (mg/dL)
Creatinine (mg/dL) .
Protein / Creatinine ratio .
Urine Pregnancy Test
Date of Urine Pregnancy Test: or if NADay Month Year
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
Screening
IND Study #______ Eligibility Checklist Pg 1 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Instructions: Check the appropriate box for each Inclusion and Exclusion Criterion below. Each criterion must bemarked and all protocol criteria have to be met prior to enrolling the subject.
Inclusion CriteriaEach criterion must be addressed and documented in the subject's medical record or source.
Y N NA
1. The diagnosis of __________ should be established by _______. In case of participation of other sub-sites in the study, pathology slides and blocks should be submitted for centralreview at the UAMS Pathology Laboratory. However, enrollment may proceed based on the results of the local review of this material.
2. Subjects should have normal serum BUN and Creatinine levels based on institutional norms at screening.
3. Subjects should have normal LVEF evaluated by MUGA scan 45% at screening.
4. Female age > 18
5. Good performance status defined by ECOG scale of 0 or 1 (Appendix F).
6. Written consent.
7. Women of childbearing potential must have a negative pregnancy test.
8. Use of effective means of contraception in subjects of child-bearing potential while on treatment and for at least 3 months thereafter.
9. Peripheral neuropathy: must be < grade 1
10. Hematologic (minimal values)Absolute neutrophil count > 1,500/mm3
Hemoglobin > 8.0 g/dlPlatelet count > 100,000/mm3
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Eligibility Checklist Pg 2 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Y N NA
11. HepaticTotal Bilirubin < ULN
AST and ALT and Alkaline Phosphatase must be within the range allowing foreligibility. In determining eligibility, the more abnormal of the two values (AST or ALT) should be used.
AST or ALT:ALK PHOS: < ULN > 1X BUT 1.5X BUT 5X ULN
< ULN Eligible Eligible Eligible Ineligible>1x but 2.5x but 5x ULN Ineligible Ineligible Ineligible Ineligible
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Eligibility Checklist Pg 3 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Exclusion CriteriaEach criterion must be addressed and documented in the subject's medical record.
Y N NAa. Disease-Specific Concerns1. Subjects who have _________________ will be excludedfrom this study due to the risk of worsening ulcers and healing difficulties
2. Stage ______ cancer
3. Inflammatory cancer
b. General Medical Concerns1. Subjects with ECOG performance status 2, 3, and 4 are not eligible for this study
2. Allergy to any component of the treatment regimen
3. Refusal to use effective contraception while participating in this study
4. Inability to comply with study and/or follow-up procedures
5. Subjects with secondary malignancy other than superficial skin cancer (squamous cell carcinoma and basal cell carcinoma of the skin) should be excluded
c. Study Drug - Specific Concerns1. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
2. Blood pressure of > 150/100 mmHg. Essential hypertension well controlled with antihypertensive is not an exclusion criterion.
3. Unstable angina
4. New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix D)
5. History of myocardial infarction within 6 months
6. History of stroke within 6 months
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Eligibility Checklist Pg 4 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Y N NA
7. Clinically significant peripheral vascular disease
8. Evidence of bleeding diathesis or coagulopathy
9. Presence of central nervous system or brain metastases
10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
11. Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
12. Pregnant (positive pregnancy test) or breast feeding
13. Urine protein: creatinine ratio >1.0 at screening
14. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
15. Serious, non-healing wound, ulcer, or bone fracture
Subject meets all eligibility criteria
If the subject did not meet all eligibility criteria, was a waiver granted by the medical monitor
Date:Signature of Principal Investigator Day Month Year
Date:Completed by Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Demographics Pg 5 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of Birth:Day Month Year
Race: White(Mark all
which apply) Black or African American
Native Hawaiian or other Pacific Islander
Asian
American Indian or Alaska Native
Unknown
Ethnicity: Hispanic or Latino(Mark only 1)
Non-Hispanic
Unknown
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Disease History Pg 6 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of initial diagnosis of ___________Day Month Year
if NDReceptor Analyses: Estrogen Positive Negative
Progesterone Positive Negative
HER2 Analyses: IHC Positive Negative
FISH Positive Negative
Staging
Primary tumor T1 T2 T3 T4
Lymph Node NX N0 N1 N2 N3
Metastasis MX M0 M1
Menopausal Status ( one):
Pre (< 6 mo since LMP and no prior bilateral ovariectomy and not on estrogen replacement)*If , a urine pregnancy test is required
Post (prior bilateral ovariectomy OR > 12 mo since LMP and no prior hysterectomy)
Above not applicable AND age < 50 (pre) Above not applicable AND age > 50 (post)
Name of Biopsy
Was _____ node sampling performed? Yes No
_______ Biopsy Date:Day Month Year
_______ Biopsy Results: Positive Negative
Number of ______ Examined: Number of ________ Positive:
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Medical History Pg 7 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Record pertinent medical and/or surgerical history in the space provided below
System Normal Abnormal List Diagnosis and Date
Head/Ears/Eyes/Nose/Throat
Respiratory
Cardiovascular
Gastrointestinal
Hepatic/GallBladder
Renal
Genitourinary
Musculoskeletal
Dermatological
Nervous System
Hematological
Lymphatic
Endocrine
Psychological/Psychiatric
Other _________________
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Radiology Pg 8 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Local/Regional
if NDDay Month Year Normal Metastatic
Chest X-ray
CT Brainand/or
MRI Brain
CT Chestand/or
MRI Chest
CT Abdomenand/or
MRI Abdomen
Bone Scan
PET CT
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ EKG Pg 9 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of ECG:Day Month Year
Overall interpretation: Normal
Clinically insignificant abnormality
Clinically significant abnormality (specify)
1
2
3
4
5
6
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Ancillary Exams Pg 10 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Date of Mammogram:Day Month Year
Normal
Abnormal
Birad: 0 1 2 3 4 5 6
Date of MUGA:Day Month Year
LVEF %
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Physical Exam Pg 11 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
WNL ABN if ND
Comment if Abnormal
General
HEENT
Chest Wall
Pulmonary
Abdomen
Musculoskeletal
Extremities
Neurological
Skin
Lymphatic
Psych
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Tumor Assessment (COR) Pg 12 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Target Lesion Measurement
Tumor laterality ( one) Left RightProduct
Site Horizontal Vertical (cm). x . .
if Not Applicable . x . .
if Not Applicable . x . .
Product of all target lesions .
Site codes: UOQ=Upper Outer Quadrant, LOQ=Lower Outer Quadrant, UIQ=Upper Inner Quadrant, LIQ=Lower Inner Quadrant, CEN=Centrally Located
Regional Nodes
Does the subject have involvement of the regional nodes/axilla? Yes complete below No
Non-palpable?
ProductSite Palpable? Measurable? Horizontal Vertical (cm)
. x . .
Product of all target lesions .
Site codes: RAX=Right Axilla, LAX=Left Axilla, RSC=Right Supraclavicular, LSC=Left Supraclavicular
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Vital Signs Pg 13 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Exam Date:Day Month Year
Height: . cm In
Weight: . kg lbs
Blood Pressure:
Pulse: minute
Temperature: . C F
Respirations: minute
Performance Status:
0 1 2
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Laboratory Pg 14 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Specimen Collection Date:
if ND
Day Month Year if ND
WBC (K/L) . Neutrophils (%) .
Absolute Neutrophil Count Total bilirubin (mg/dL) .
Platelets (K/L) LDH (IU/L)
RBC (M/L) . Alk. phos. (IU/L)
Hemoglobin (g/dL) . SGOT/AST (IU/L)
BUN (mg/dL) SGPT/ALT (IU/L)
Creatinine (mg/dL) . GGT (IU/L)
Sodium (mEq/L) PT (sec) .
Potassium (mEq/L) . PTT (sec) .
CO2 (mEq/L) INR .
Chloride (mEq/L)
Assay Collection if ND
_____________ :Day Month Year H H M M
_____________ :Day Month Year H H M M
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
IND Study #______ Urine Analysis Pg 15 of 15
Visit 0 . 0
Subject ID: I N D # # U A * Consent Date:Day Month Year
Subject Initials:
Specimen Collection Date:Day Month Year
UPC if ND
Protein (mg/dL)
Creatinine (mg/dL) .
Protein / Creatinine ratio .
Urine Pregnancy Test
Date of Urine Pregnancy Test: or if NADay Month Year
Completed by: On:Day Month Year
IRB # _______ 23Aug2006Version 4.0
Screening
IND Study #______ Physical Exam Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
if NDWNL ABN Comment if Abnormal
General
HEENT
Chest Wall
Pulmonary
Abdomen
Musculoskeletal
Extremities
Neurological
Skin
Lymphatic
Psych
Completed by: Date:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Tumor Assessment (COR) Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Check here if tumor assessment was not performed
Target Lesion Measurement
Tumor laterality (check one) Left RightProduct
Site Horizontal Vertical (cm)
. x . .
if Not Applicable . x . .
Product of all target lesions .
Site codes: UOQ=Upper Outer Quadrant, LOQ=Lower Outer Quadrant, UIQ=Upper Inner Quadrant, LIQ=Lower Inner Quadrant, CEN=Centrally Located
Regional Nodes/Axilla
Does the subject have involvement of the regional nodes/axilla? Yes complete below No
Non-palpable?
ProductSite Palpable? Measurable? Horizontal Vertical (cm)
. x . .
Product of all target lesions .
Site codes: RAX=Right Axilla, LAX=Left Axilla, RSC=Right Supraclavicular, LSC=Left Supraclavicular
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Vital Signs Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Check here if vital signs were not performed
Date of this exam:Day Month Year
Height: . cm In
Weight: . kg lbs
Blood Pressure:
Pulse: minute
Temperature: . C F
Respirations: minute
Performance Status: 0 1 2
if Not Applicable if Not Done
Post Treatment Time: :H H M M
Blood pressure: /
Pulse: / minute
Temperature: . C F
Respirations: / minute
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Laboratory Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Specimen Collection Date:Day Month Year
if ND
if ND
WBC (K/L) . Neutrophils (%) .
Absolute Neutrophil Count Total bilirubin (mg/dL) .
Platelets (K/L) LDH (IU/L)
RBC (M/L) . Alk. phos. (IU/L)
Hemoglobin (g/dL) . SGOT/AST (IU/L)
BUN (mg/dL) SGPT/ALT (IU/L)
Creatinine (mg/dL) . GGT (IU/L)
Sodium (mEq/L) PT (sec) .
Potassium (mEq/L) . PTT (sec) .
CO2 (mEq/L) INR .
Chloride (mEq/L)
Assay Collection
__________ :Day Month Year H H M M
__________ :Day Month Year H H M M
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Urine Analysis Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Specimen Collection Date:Day Month Year
UPC if ND
Protein (mg/dL)
Creatinine (mg/dL) .
Protein / Creatinine ratio .
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Drug Information Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Study Drug Dosing Information
IND Drug (15mg/kg) mgDay Month Year
Lot No. Infusion Time: Start Time :
Solution 90 Mins Stop Time :
Reaction: Yes 60 Mins
No 30 Mins
Docetaxel (75mg/m2) mgDay Month Year
Cyclophosphamide mg
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Drug Information Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Study Drug Dosing Information
Doxorubicin (60mg/m2) mgDay Month Year
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Ancillary Exams Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
if Not Applicable if Not Done
Date of MammogramDay Month Year
Normal
Abnormal
Birad: 0 1 2 3 4 5 6
if Not Applicable if Not Done
Date of MUGA:Day Month Year
LVEF %
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Drug Information Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Study Drug Dosing Information
IND Drug (15mg/kg) mg
Lot No. Infusion Time: Start Time :
Solution 90 Mins Stop Time :
Reaction: Yes 60 Mins
No 30 Mins
Vital Signs
if Not Applicable if Not Done
Post Treatment Time: :H H M M
Blood pressure /
Pulse / minute
Temperature . C F
Respirations / minute
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Pathologic Response Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Miller and Payne classification Grade 1Some alteration to individual malignant cells but no reduction in overall number
Grade 2Minor loss of invasive tumor cells but overall cellularity still high
Grade 3Moderate reduction in tumor cells up to an estimated 90% loss
Grade 4Marked disappearance of invasive tumor cells such that only small clusters of widely dispersed cells detected
Grade 5 (pCR of the primary tumor)No invasive cells identifiable in sections from the site of the previous tumor
ALN N/A
ATrue ALN negative
BALN positive, no therapeutic response
CALN positive, evidence of partial pathological response
DALN previously positive but converted to node negative after NC
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Hormonal/XRT Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Hormonal
Was treatment with hormonal therapy indicated in this subject? Yes No
If yes, record all treatments (tamoxifen or anastrozole only) including doses, dates and indications on the Concurrent Medication pages
Radiation
Was treatment with radiation indicated in this subject? Yes No
Radiation Start Date:Day Month Year
Radiation Stop Date:Day Month Year
Was treatment with radiation completed? Yes No
Total cGy administered:
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
Extra forms
IND Study #______ Physical Exam Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
if NDWNL ABN Comment if Abnormal
General
HEENT
Chest Wall
Pulmonary
Abdomen
Musculoskeletal
Extremities
Neurological
Skin
Lymphatic
Psych
Completed by: Date:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Tumor Assessment (COR) Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Check here if tumor assessment was not performed
Target Lesion Measurement
Tumor laterality (check one) Left RightProduct
Site Horizontal Vertical (cm)
. x . .
if Not Applicable . x . .
Product of all target lesions .
Site codes: UOQ=Upper Outer Quadrant, LOQ=Lower Outer Quadrant, UIQ=Upper Inner Quadrant, LIQ=Lower Inner Quadrant, CEN=Centrally Located
Regional Nodes/Axilla
Does the subject have involvement of the regional nodes/axilla? Yes complete below No
Non-palpable?
ProductSite Palpable? Measurable? Horizontal Vertical (cm)
. x . .
Product of all target lesions .
Site codes: RAX=Right Axilla, LAX=Left Axilla, RSC=Right Supraclavicular, LSC=Left Supraclavicular
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Vital Signs Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Check here if vital signs were not performed
Date of this exam:Day Month Year
Height: . cm In
Weight: . kg lbs
Blood Pressure:
Pulse: minute
Temperature: . C F
Respirations: minute
Performance Status: 0 1 2
if Not Applicable if Not Done
Post Treatment Time: :H H M M
Blood pressure: /
Pulse: / minute
Temperature: . C F
Respirations: / minute
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Laboratory Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Specimen Collection Date:Day Month Year
if ND
if ND
WBC (K/L) . Neutrophils (%) .
Absolute Neutrophil Count Total bilirubin (mg/dL) .
Platelets (K/L) LDH (IU/L)
RBC (M/L) . Alk. phos. (IU/L)
Hemoglobin (g/dL) . SGOT/AST (IU/L)
BUN (mg/dL) SGPT/ALT (IU/L)
Creatinine (mg/dL) . GGT (IU/L)
Sodium (mEq/L) PT (sec) .
Potassium (mEq/L) . PTT (sec) .
CO2 (mEq/L) INR .
Chloride (mEq/L)
Assay Collection
__________ :Day Month Year H H M M
__________ :Day Month Year H H M M
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Urine Analysis Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Specimen Collection Date:Day Month Year
UPC if ND
Protein (mg/dL)
Creatinine (mg/dL) .
Protein / Creatinine ratio .
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Drug Information Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Study Drug Dosing Information
IND Drug (15mg/kg) mgDay Month Year
Lot No. Infusion Time: Start Time :
Solution 90 Mins Stop Time :
Reaction: Yes 60 Mins
No 30 Mins
Docetaxel (75mg/m2) mgDay Month Year
Cyclophosphamide mg
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Drug Information Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Study Drug Dosing Information
Doxorubicin (60mg/m2) mgDay Month Year
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Ancillary Exams Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
if Not Applicable if Not Done
Date of MammogramDay Month Year
Normal
Abnormal
Birad: 0 1 2 3 4 5 6
if Not Applicable if Not Done
Date of MUGA:Day Month Year
LVEF %
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Drug Information Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Study Drug Dosing Information
IND Drug (15mg/kg) mg
Lot No. Infusion Time: Start Time :
Solution 90 Mins Stop Time :
Reaction: Yes 60 Mins
No 30 Mins
Vital Signs
if Not Applicable if Not Done
Post Treatment Time: :H H M M
Blood pressure /
Pulse / minute
Temperature . C F
Respirations / minute
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Pathologic Response Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Miller and Payne classification Grade 1Some alteration to individual malignant cells but no reduction in overall number
Grade 2Minor loss of invasive tumor cells but overall cellularity still high
Grade 3Moderate reduction in tumor cells up to an estimated 90% loss
Grade 4Marked disappearance of invasive tumor cells such that only small clusters of widely dispersed cells detected
Grade 5 (pCR of the primary tumor)No invasive cells identifiable in sections from the site of the previous tumor
ALN N/A
ATrue ALN negative
BALN positive, no therapeutic response
CALN positive, evidence of partial pathological response
DALN previously positive but converted to node negative after NC
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Hormonal/XRT Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Hormonal
Was treatment with hormonal therapy indicated in this subject? Yes No
If yes, record all treatments (tamoxifen or anastrozole only) including doses, dates and indications on the Concurrent Medication pages
Radiation
Was treatment with radiation indicated in this subject? Yes No
Radiation Start Date:Day Month Year
Radiation Stop Date:Day Month Year
Was treatment with radiation completed? Yes No
Total cGy administered:
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
Extra forms
IND Study #______ Physical Exam Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
if NDWNL ABN Comment if Abnormal
General
HEENT
Chest Wall
Pulmonary
Abdomen
Musculoskeletal
Extremities
Neurological
Skin
Lymphatic
Psych
Completed by: Date:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Tumor Assessment (COR) Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Check here if tumor assessment was not performed
Target Lesion Measurement
Tumor laterality (check one) Left RightProduct
Site Horizontal Vertical (cm)
. x . .
if Not Applicable . x . .
Product of all target lesions .
Site codes: UOQ=Upper Outer Quadrant, LOQ=Lower Outer Quadrant, UIQ=Upper Inner Quadrant, LIQ=Lower Inner Quadrant, CEN=Centrally Located
Regional Nodes/Axilla
Does the subject have involvement of the regional nodes/axilla? Yes complete below No
Non-palpable?
ProductSite Palpable? Measurable? Horizontal Vertical (cm)
. x . .
Product of all target lesions .
Site codes: RAX=Right Axilla, LAX=Left Axilla, RSC=Right Supraclavicular, LSC=Left Supraclavicular
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Vital Signs Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Check here if vital signs were not performed
Date of this exam:Day Month Year
Height: . cm In
Weight: . kg lbs
Blood Pressure:
Pulse: minute
Temperature: . C F
Respirations: minute
Performance Status: 0 1 2
if Not Applicable if Not Done
Post Treatment Time: :H H M M
Blood pressure: /
Pulse: / minute
Temperature: . C F
Respirations: / minute
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Laboratory Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Specimen Collection Date:Day Month Year
if ND
if ND
WBC (K/L) . Neutrophils (%) .
Absolute Neutrophil Count Total bilirubin (mg/dL) .
Platelets (K/L) LDH (IU/L)
RBC (M/L) . Alk. phos. (IU/L)
Hemoglobin (g/dL) . SGOT/AST (IU/L)
BUN (mg/dL) SGPT/ALT (IU/L)
Creatinine (mg/dL) . GGT (IU/L)
Sodium (mEq/L) PT (sec) .
Potassium (mEq/L) . PTT (sec) .
CO2 (mEq/L) INR .
Chloride (mEq/L)
Assay Collection
__________ :Day Month Year H H M M
__________ :Day Month Year H H M M
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Urine Analysis Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Specimen Collection Date:Day Month Year
UPC if ND
Protein (mg/dL)
Creatinine (mg/dL) .
Protein / Creatinine ratio .
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Drug Information Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Study Drug Dosing Information
IND Drug (15mg/kg) mgDay Month Year
Lot No. Infusion Time: Start Time :
Solution 90 Mins Stop Time :
Reaction: Yes 60 Mins
No 30 Mins
Docetaxel (75mg/m2) mgDay Month Year
Cyclophosphamide mg
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Drug Information Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Study Drug Dosing Information
Doxorubicin (60mg/m2) mgDay Month Year
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Ancillary Exams Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
if Not Applicable if Not Done
Date of MammogramDay Month Year
Normal
Abnormal
Birad: 0 1 2 3 4 5 6
if Not Applicable if Not Done
Date of MUGA:Day Month Year
LVEF %
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Drug Information Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Study Drug Dosing Information
IND Drug (15mg/kg) mg
Lot No. Infusion Time: Start Time :
Solution 90 Mins Stop Time :
Reaction: Yes 60 Mins
No 30 Mins
Vital Signs
if Not Applicable if Not Done
Post Treatment Time: :H H M M
Blood pressure /
Pulse / minute
Temperature . C F
Respirations / minute
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Pathologic Response Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Miller and Payne classification Grade 1Some alteration to individual malignant cells but no reduction in overall number
Grade 2Minor loss of invasive tumor cells but overall cellularity still high
Grade 3Moderate reduction in tumor cells up to an estimated 90% loss
Grade 4Marked disappearance of invasive tumor cells such that only small clusters of widely dispersed cells detected
Grade 5 (pCR of the primary tumor)No invasive cells identifiable in sections from the site of the previous tumor
ALN N/A
ATrue ALN negative
BALN positive, no therapeutic response
CALN positive, evidence of partial pathological response
DALN previously positive but converted to node negative after NC
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Hormonal/XRT Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Hormonal
Was treatment with hormonal therapy indicated in this subject? Yes No
If yes, record all treatments (tamoxifen or anastrozole only) including doses, dates and indications on the Concurrent Medication pages
Radiation
Was treatment with radiation indicated in this subject? Yes No
Radiation Start Date:Day Month Year
Radiation Stop Date:Day Month Year
Was treatment with radiation completed? Yes No
Total cGy administered:
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
Extra forms
IND Study #______ Physical Exam Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
if NDWNL ABN Comment if Abnormal
General
HEENT
Chest Wall
Pulmonary
Abdomen
Musculoskeletal
Extremities
Neurological
Skin
Lymphatic
Psych
Completed by: Date:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Tumor Assessment (COR) Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Check here if tumor assessment was not performed
Target Lesion Measurement
Tumor laterality (check one) Left RightProduct
Site Horizontal Vertical (cm)
. x . .
if Not Applicable . x . .
Product of all target lesions .
Site codes: UOQ=Upper Outer Quadrant, LOQ=Lower Outer Quadrant, UIQ=Upper Inner Quadrant, LIQ=Lower Inner Quadrant, CEN=Centrally Located
Regional Nodes/Axilla
Does the subject have involvement of the regional nodes/axilla? Yes complete below No
Non-palpable?
ProductSite Palpable? Measurable? Horizontal Vertical (cm)
. x . .
Product of all target lesions .
Site codes: RAX=Right Axilla, LAX=Left Axilla, RSC=Right Supraclavicular, LSC=Left Supraclavicular
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Vital Signs Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Check here if vital signs were not performed
Date of this exam:Day Month Year
Height: . cm In
Weight: . kg lbs
Blood Pressure:
Pulse: minute
Temperature: . C F
Respirations: minute
Performance Status: 0 1 2
if Not Applicable if Not Done
Post Treatment Time: :H H M M
Blood pressure: /
Pulse: / minute
Temperature: . C F
Respirations: / minute
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Laboratory Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Specimen Collection Date:Day Month Year
if ND
if ND
WBC (K/L) . Neutrophils (%) .
Absolute Neutrophil Count Total bilirubin (mg/dL) .
Platelets (K/L) LDH (IU/L)
RBC (M/L) . Alk. phos. (IU/L)
Hemoglobin (g/dL) . SGOT/AST (IU/L)
BUN (mg/dL) SGPT/ALT (IU/L)
Creatinine (mg/dL) . GGT (IU/L)
Sodium (mEq/L) PT (sec) .
Potassium (mEq/L) . PTT (sec) .
CO2 (mEq/L) INR .
Chloride (mEq/L)
Assay Collection
__________ :Day Month Year H H M M
__________ :Day Month Year H H M M
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Urine Analysis Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Specimen Collection Date:Day Month Year
UPC if ND
Protein (mg/dL)
Creatinine (mg/dL) .
Protein / Creatinine ratio .
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Drug Information Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Study Drug Dosing Information
IND Drug (15mg/kg) mgDay Month Year
Lot No. Infusion Time: Start Time :
Solution 90 Mins Stop Time :
Reaction: Yes 60 Mins
No 30 Mins
Docetaxel (75mg/m2) mgDay Month Year
Cyclophosphamide mg
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Drug Information Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Study Drug Dosing Information
Doxorubicin (60mg/m2) mgDay Month Year
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Ancillary Exams Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
if Not Applicable if Not Done
Date of MammogramDay Month Year
Normal
Abnormal
Birad: 0 1 2 3 4 5 6
if Not Applicable if Not Done
Date of MUGA:Day Month Year
LVEF %
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Drug Information Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Study Drug Dosing Information
IND Drug (15mg/kg) mg
Lot No. Infusion Time: Start Time :
Solution 90 Mins Stop Time :
Reaction: Yes 60 Mins
No 30 Mins
Vital Signs
if Not Applicable if Not Done
Post Treatment Time: :H H M M
Blood pressure /
Pulse / minute
Temperature . C F
Respirations / minute
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Pathologic Response Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Miller and Payne classification Grade 1Some alteration to individual malignant cells but no reduction in overall number
Grade 2Minor loss of invasive tumor cells but overall cellularity still high
Grade 3Moderate reduction in tumor cells up to an estimated 90% loss
Grade 4Marked disappearance of invasive tumor cells such that only small clusters of widely dispersed cells detected
Grade 5 (pCR of the primary tumor)No invasive cells identifiable in sections from the site of the previous tumor
ALN N/A
ATrue ALN negative
BALN positive, no therapeutic response
CALN positive, evidence of partial pathological response
DALN previously positive but converted to node negative after NC
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Hormonal/XRT Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Hormonal
Was treatment with hormonal therapy indicated in this subject? Yes No
If yes, record all treatments (tamoxifen or anastrozole only) including doses, dates and indications on the Concurrent Medication pages
Radiation
Was treatment with radiation indicated in this subject? Yes No
Radiation Start Date:Day Month Year
Radiation Stop Date:Day Month Year
Was treatment with radiation completed? Yes No
Total cGy administered:
Completed by: On:Day Month Year
IRB # _______ 23Aug2006
Version4.0
Extra forms
IND Study #______ Physical Exam Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
if NDWNL ABN Comment if Abnormal
General
HEENT
Chest Wall
Pulmonary
Abdomen
Musculoskeletal
Extremities
Neurological
Skin
Lymphatic
Psych
Completed by: Date:Day Month Year
IRB # _______ 23Aug2006
Version4.0
IND Study #______ Tumor Assessment (COR) Pg of
Visit
Subject ID: I N D # # U A * Visit Date:Day Month Year
Subject Initials:
Check here if tumor assessment was not performed
Top Related