MODULE B: Case Report Forms Jane Fendl & Denise Thwing April 7, 2010 1 Version: Final 07-Apr-2010

Case Report Forms

MODULE B: Case Report Forms

Jane Fendl & Denise Thwing

April 7, 2010

www.nihtraining.com/cc/ippcr/current/.../Mailhot020706.ppt

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Version: Final 07-Apr-2010

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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

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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

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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

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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

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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

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Elements of the CRF

Three major parts:

Header

Safety related modules

Efficacy related modules

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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

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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

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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

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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

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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

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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

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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.


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

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The CRA is responsible for designing the CRF Book to parallel the efficacy and safety parameters indicated in the protocol.


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

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The CRA is responsible for designing the CRF Book to parallel the efficacy and safety parameters indicated in the protocol.


Review Team (example)

Project Clinician

Lead CRA

Lead Statistician

Lead Programmer

Lead Data Manager

Others

Database Development, Dictionary Coding, Standards

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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.


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

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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

+

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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

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Poorly Designed CRF Issues

=

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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

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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

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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

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Questions ?

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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


Visit 0 . 0


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


Visit 0 . 0


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


Visit 0 . 0


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 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 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:


IRB # _______ 23Aug2006Version 4.0

IND Study #______ Medical History Pg 7 of 15

Visit 0 . 0


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 _________________


IRB # _______ 23Aug2006Version 4.0

IND Study #______ Radiology Pg 8 of 15

Visit 0 . 0


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


IRB # _______ 23Aug2006Version 4.0

IND Study #______ EKG Pg 9 of 15

Visit 0 . 0


Subject Initials:

Date of ECG:Day Month Year

Overall interpretation: Normal

Clinically insignificant abnormality

Clinically significant abnormality (specify)

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2

3

4

5

6


IRB # _______ 23Aug2006Version 4.0

IND Study #______ Ancillary Exams Pg 10 of 15

Visit 0 . 0


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 %


IRB # _______ 23Aug2006Version 4.0

IND Study #______ Physical Exam Pg 11 of 15

Visit 0 . 0


Subject Initials:

WNL ABN if ND

Comment if Abnormal

General

HEENT

Chest Wall

Pulmonary

Abdomen

Musculoskeletal

Extremities

Neurological

Skin

Lymphatic

Psych


IRB # _______ 23Aug2006Version 4.0

IND Study #______ Tumor Assessment (COR) Pg 12 of 15

Visit 0 . 0


Subject Initials:

Target Lesion Measurement

Tumor laterality ( 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

Does the subject have involvement of the regional nodes/axilla? Yes complete below No

Non-palpable?

ProductSite Palpable? Measurable? Horizontal Vertical (cm)

. x . .


Site codes: RAX=Right Axilla, LAX=Left Axilla, RSC=Right Supraclavicular, LSC=Left Supraclavicular


IRB # _______ 23Aug2006Version 4.0

IND Study #______ Vital Signs Pg 13 of 15

Visit 0 . 0


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


IRB # _______ 23Aug2006Version 4.0

IND Study #______ Laboratory Pg 14 of 15

Visit 0 . 0


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



IRB # _______ 23Aug2006Version 4.0

IND Study #______ Urine Analysis Pg 15 of 15

Visit 0 . 0


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


IRB # _______ 23Aug2006Version 4.0

Screening


Visit 0 . 0


Subject Initials:



Y N NA




4. Female age > 18


6. Written consent.






IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:

Y N NA





IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:












3. Unstable angina




IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:

Y N NA














IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:





Asian


Unknown


Non-Hispanic

Unknown


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:






Staging



Metastasis MX M0 M1





Name of Biopsy






IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:




Respiratory

Cardiovascular

Gastrointestinal

Hepatic/GallBladder

Renal

Genitourinary

Musculoskeletal

Dermatological

Nervous System

Hematological

Lymphatic

Endocrine


Other _________________


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:

Local/Regional


Chest X-ray

CT Brainand/or

MRI Brain

CT Chestand/or

MRI Chest

CT Abdomenand/or

MRI Abdomen

Bone Scan

PET CT


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:





1

2

3

4

5

6


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:


Normal

Abnormal

Birad: 0 1 2 3 4 5 6


LVEF %


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:

WNL ABN if ND

Comment if Abnormal

General

HEENT

Chest Wall

Pulmonary

Abdomen

Musculoskeletal

Extremities

Neurological

Skin

Lymphatic

Psych


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:








Regional Nodes


Non-palpable?


. x . .




IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:


Height: . cm In

Weight: . kg lbs

Blood Pressure:

Pulse: minute

Temperature: . C F


Performance Status:

0 1 2


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:


if ND











CO2 (mEq/L) INR .

Chloride (mEq/L)





IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:


UPC if ND

Protein (mg/dL)






IRB # _______ 23Aug2006Version 4.0

Screening


Visit 0 . 0


Subject Initials:



Y N NA




4. Female age > 18


6. Written consent.






IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:

Y N NA





IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:












3. Unstable angina




IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:

Y N NA














IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:





Asian


Unknown


Non-Hispanic

Unknown


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:






Staging



Metastasis MX M0 M1





Name of Biopsy






IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:




Respiratory

Cardiovascular

Gastrointestinal

Hepatic/GallBladder

Renal

Genitourinary

Musculoskeletal

Dermatological

Nervous System

Hematological

Lymphatic

Endocrine


Other _________________


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:

Local/Regional


Chest X-ray

CT Brainand/or

MRI Brain

CT Chestand/or

MRI Chest

CT Abdomenand/or

MRI Abdomen

Bone Scan

PET CT


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:





1

2

3

4

5

6


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:


Normal

Abnormal

Birad: 0 1 2 3 4 5 6


LVEF %


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:

WNL ABN if ND

Comment if Abnormal

General

HEENT

Chest Wall

Pulmonary

Abdomen

Musculoskeletal

Extremities

Neurological

Skin

Lymphatic

Psych


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:








Regional Nodes


Non-palpable?


. x . .




IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:


Height: . cm In

Weight: . kg lbs

Blood Pressure:

Pulse: minute

Temperature: . C F


Performance Status:

0 1 2


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:


if ND











CO2 (mEq/L) INR .

Chloride (mEq/L)





IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:


UPC if ND

Protein (mg/dL)






IRB # _______ 23Aug2006Version 4.0

Screening


Visit 0 . 0


Subject Initials:



Y N NA




4. Female age > 18


6. Written consent.






IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:

Y N NA





IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:












3. Unstable angina




IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:

Y N NA














IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:





Asian


Unknown


Non-Hispanic

Unknown


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:






Staging



Metastasis MX M0 M1





Name of Biopsy






IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:




Respiratory

Cardiovascular

Gastrointestinal

Hepatic/GallBladder

Renal

Genitourinary

Musculoskeletal

Dermatological

Nervous System

Hematological

Lymphatic

Endocrine


Other _________________


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:

Local/Regional


Chest X-ray

CT Brainand/or

MRI Brain

CT Chestand/or

MRI Chest

CT Abdomenand/or

MRI Abdomen

Bone Scan

PET CT


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:





1

2

3

4

5

6


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:


Normal

Abnormal

Birad: 0 1 2 3 4 5 6


LVEF %


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:

WNL ABN if ND

Comment if Abnormal

General

HEENT

Chest Wall

Pulmonary

Abdomen

Musculoskeletal

Extremities

Neurological

Skin

Lymphatic

Psych


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:








Regional Nodes


Non-palpable?


. x . .




IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:


Height: . cm In

Weight: . kg lbs

Blood Pressure:

Pulse: minute

Temperature: . C F


Performance Status:

0 1 2


IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:


if ND











CO2 (mEq/L) INR .

Chloride (mEq/L)





IRB # _______ 23Aug2006Version 4.0


Visit 0 . 0


Subject Initials:


UPC if ND

Protein (mg/dL)






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 Initials:

Check here if tumor assessment was not performed


Tumor laterality (check one) Left RightProduct

Site Horizontal Vertical (cm)

. x . .




Regional Nodes/Axilla


Non-palpable?


. x . .




IRB # _______ 23Aug2006

Version4.0

IND Study #______ Vital Signs Pg of

Visit


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


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


IRB # _______ 23Aug2006

Version4.0

IND Study #______ Laboratory Pg of

Visit


Subject Initials:


if ND

if ND










CO2 (mEq/L) INR .

Chloride (mEq/L)

Assay Collection

__________ :Day Month Year H H M M



IRB # _______ 23Aug2006

Version4.0

IND Study #______ Urine Analysis Pg of

Visit


Subject Initials:


UPC if ND

Protein (mg/dL)




IRB # _______ 23Aug2006

Version4.0

IND Study #______ Drug Information Pg of

Visit


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


IRB # _______ 23Aug2006

Version4.0


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Doxorubicin (60mg/m2) mgDay Month Year


IRB # _______ 23Aug2006

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IND Study #______ Ancillary Exams Pg of

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Date of MammogramDay Month Year

Normal

Abnormal

Birad: 0 1 2 3 4 5 6



LVEF %


IRB # _______ 23Aug2006

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IND Drug (15mg/kg) mg




No 30 Mins

Vital Signs



Blood pressure /

Pulse / minute

Temperature . C F

Respirations / minute


IRB # _______ 23Aug2006

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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


IRB # _______ 23Aug2006

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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:


IRB # _______ 23Aug2006

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General

HEENT

Chest Wall

Pulmonary

Abdomen

Musculoskeletal

Extremities

Neurological

Skin

Lymphatic

Psych


IRB # _______ 23Aug2006

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. x . .






Non-palpable?


. x . .




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Height: . cm In

Weight: . kg lbs

Blood Pressure:

Pulse: minute

Temperature: . C F





Blood pressure: /

Pulse: / minute

Temperature: . C F



IRB # _______ 23Aug2006

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if ND

if ND










CO2 (mEq/L) INR .

Chloride (mEq/L)

Assay Collection




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UPC if ND

Protein (mg/dL)




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No 30 Mins


Cyclophosphamide mg


IRB # _______ 23Aug2006

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IRB # _______ 23Aug2006

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Normal

Abnormal

Birad: 0 1 2 3 4 5 6



LVEF %


IRB # _______ 23Aug2006

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No 30 Mins

Vital Signs



Blood pressure /

Pulse / minute

Temperature . C F



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ALN N/A

ATrue ALN negative





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Hormonal



Radiation







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General

HEENT

Chest Wall

Pulmonary

Abdomen

Musculoskeletal

Extremities

Neurological

Skin

Lymphatic

Psych


IRB # _______ 23Aug2006

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. x . .






Non-palpable?


. x . .




IRB # _______ 23Aug2006

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Height: . cm In

Weight: . kg lbs

Blood Pressure:

Pulse: minute

Temperature: . C F





Blood pressure: /

Pulse: / minute

Temperature: . C F



IRB # _______ 23Aug2006

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if ND

if ND










CO2 (mEq/L) INR .

Chloride (mEq/L)

Assay Collection




IRB # _______ 23Aug2006

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UPC if ND

Protein (mg/dL)




IRB # _______ 23Aug2006

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No 30 Mins


Cyclophosphamide mg


IRB # _______ 23Aug2006

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IRB # _______ 23Aug2006

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Normal

Abnormal

Birad: 0 1 2 3 4 5 6



LVEF %


IRB # _______ 23Aug2006

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No 30 Mins

Vital Signs



Blood pressure /

Pulse / minute

Temperature . C F



IRB # _______ 23Aug2006

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ALN N/A

ATrue ALN negative





IRB # _______ 23Aug2006

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Hormonal



Radiation







IRB # _______ 23Aug2006

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General

HEENT

Chest Wall

Pulmonary

Abdomen

Musculoskeletal

Extremities

Neurological

Skin

Lymphatic

Psych


IRB # _______ 23Aug2006

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. x . .






Non-palpable?


. x . .




IRB # _______ 23Aug2006

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Height: . cm In

Weight: . kg lbs

Blood Pressure:

Pulse: minute

Temperature: . C F





Blood pressure: /

Pulse: / minute

Temperature: . C F



IRB # _______ 23Aug2006

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if ND

if ND










CO2 (mEq/L) INR .

Chloride (mEq/L)

Assay Collection




IRB # _______ 23Aug2006

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UPC if ND

Protein (mg/dL)




IRB # _______ 23Aug2006

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No 30 Mins


Cyclophosphamide mg


IRB # _______ 23Aug2006

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IRB # _______ 23Aug2006

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Normal

Abnormal

Birad: 0 1 2 3 4 5 6



LVEF %


IRB # _______ 23Aug2006

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No 30 Mins

Vital Signs



Blood pressure /

Pulse / minute

Temperature . C F



IRB # _______ 23Aug2006

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ALN N/A

ATrue ALN negative





IRB # _______ 23Aug2006

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Hormonal



Radiation







IRB # _______ 23Aug2006

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General

HEENT

Chest Wall

Pulmonary

Abdomen

Musculoskeletal

Extremities

Neurological

Skin

Lymphatic

Psych


IRB # _______ 23Aug2006

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Documents

MODULE B: Case Report Forms Jane Fendl & Denise Thwing April 7, 2010 1 Version: Final 07-Apr-2010