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CONFIDENTIAL
13-TLEC Natural History and Biology of Long-Term Late Effects
Following Hematopoietic Cell Transplant for Childhood Hematologic Malignancies
Case Report Form Example
13-TLEC Case Report Forms
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Contents Form and Visit Matrix.............................................................................................................................................................. 3
Demographics Form ................................................................................................................................................................ 4
Form notes .......................................................................................................................................................................... 4
Inclusion/Exclusion Form (Screening folder) .......................................................................................................................... 5
Form notes .......................................................................................................................................................................... 6
Help text .............................................................................................................................................................................. 6
Medical History form (Baseline Visit) ...................................................................................................................................... 7
Form notes .......................................................................................................................................................................... 8
Disease status dynamic search list ...................................................................................................................................... 9
Help text .............................................................................................................................................................................. 9
Exam (Baseline, Day 30, Day 100, Day 180, 1 year, and 2 year visits) .................................................................................. 10
Ranges ............................................................................................................................................................................... 10
Karnofsky/Lansky dynamic search list .............................................................................................................................. 11
Medications (Baseline, Day 100, Day 180, 1 year, and 2 year visits) .................................................................................... 12
Form notes ........................................................................................................................................................................ 12
Help text ............................................................................................................................................................................ 12
Corticosteroid ....................................................................................................................................................................... 13
Log line expanded ............................................................................................................................................................. 13
Help text ............................................................................................................................................................................ 14
Form level help text ...................................................................................................................................................... 14
Question level help texts .............................................................................................................................................. 14
Labs (Baseline, Day 30, Day 100, Day 180, 1 year, and 2 year visits).................................................................................... 15
Form notes ........................................................................................................................................................................ 16
Help text ............................................................................................................................................................................ 16
Ranges ............................................................................................................................................................................... 16
Unit dictionary .................................................................................................................................................................. 17
DXA scan (Baseline, 1 year, and 2 year visits) ....................................................................................................................... 18
Form notes ........................................................................................................................................................................ 18
Radiograph ............................................................................................................................................................................ 18
Form notes ........................................................................................................................................................................ 18
Conditioning Regimen (Conditioning visit) ........................................................................................................................... 19
Log Line expanded ............................................................................................................................................................ 20
Form notes ........................................................................................................................................................................ 20
Conditioning agent dynamic search list ............................................................................................................................ 20
Transplant Form (Transplant visit) ........................................................................................................................................ 22
13-TLEC Case Report Forms
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Form notes ........................................................................................................................................................................ 22
Post Transplant Follow up (Day 30, Day 100, Day 180, 1 year, and 2 year visits) ................................................................ 23
Form notes ........................................................................................................................................................................ 24
Medical Conditions (Day 100, Day 180, 1 year and 2 year visits) ......................................................................................... 25
Help text ............................................................................................................................................................................ 25
Treatments ............................................................................................................................................................................ 27
Acute GVHD (Day 100, Day 180, 1 year and 2 year visits) .................................................................................................... 28
Form notes ........................................................................................................................................................................ 29
Therapy dropdown choices: .......................................................................................................................................... 29
Chronic GVHD ....................................................................................................................................................................... 30
Form notes ........................................................................................................................................................................ 31
Therapy dropdown choices: .......................................................................................................................................... 31
Unanticipated Problem ......................................................................................................................................................... 32
Form notes ........................................................................................................................................................................ 32
Study Exit .............................................................................................................................................................................. 33
Form notes ........................................................................................................................................................................ 33
Help text ............................................................................................................................................................................ 33
13-TLEC Case Report Forms
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Form and Visit Matrix
Subject Screening Baseline Conditioning Transplant
Day 30
Day 100
Day 180 Year 1 Year 2
Steroid Review
Study Exit UAP
Demographics
Inclusion/Exclusion criteria
Medical history
Post transplant follow up
Exam
Medical conditions
Treatments
Medications
Corticosteroid
Labs
DXA scan
Radiograph
Acute GVHD
Chronic GHVD
Conditioning regimen
Transplant
Unanticipated Problem
Study Exit
Yellow highlight indicates forms that are dynamically added within a visit when a trigger question is answered ‘Yes’.
13-TLEC Case Report Forms
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Demographics Form
Form notes This is the primary form for 13-TLEC. The Age field is derived from the Date of birth and Date informed
consent signed. If the Age is > 21, the form will be marked non-compliant and the subject does move on in the
study. The Subject ID and Subject status fields are derived and not able to be edited. The Subject status after
completion of the Demographics form is ‘Screening’.
13-TLEC Case Report Forms
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Form notes If all Inclusion questions are answered Yes and all Exclusion questions are answered No then the Eligibility
question is derived to be Yes. The Enrollment date field will be derived as the date the Eligibility question is
Yes. The Screen failure date will be derived as the date the Eligibility question is No. The subject status at the
completion of this form will be ‘Enrolled’ if eligibility is Yes and ‘Screen failed’ if eligibility is No.
Help text
Questions marked with a have associated help text.
Help text for diseases allowed:
Help text for conditioning regimen:
13-TLEC Case Report Forms
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Form notes The indented questions are visible once the form is saved if the question preceding it is selected to be Yes.
13-TLEC Case Report Forms
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Disease status dynamic search list The disease status question is a dynamic search listed based on the disease selected. See table below for a list of
values.
Acute lymphoblastic leukemia (ALL) 1st complete remission
2nd complete remission
≥ 3rd complete remission
Acute myelogenous leukemia (AML or ANLL) 1st complete remission
2nd complete remission
≥ 3rd complete remission
Chronic myelogenous leukemia (CML) Complete hematologic remission
First chronic phase
Second or greater chronic phase
Accelerated phase
Blast crisis
Juvenile myelomonocytic leukemia (JMML/JCML) Complete remission
Hematologic improvement
No response/stable disease
Progression from hematologic improvement
Relapse from complete remission
Not assessed
Myelodysplastic (MDS) / myeloproliferative (MPN)
diseases Complete remission
Hematologic improvement
No response/stable disease
Progression from hematologic improvement
Relapse from complete remission
Not assessed
Help text Dyslipidemia
Fasting levels:
Triglyceride level >150 mg/dL;
HDL cholesterol level <40 mg/dL;
and/or LDL cholesterol level >130 mg/dL
Osteopenia
Osteopenia: Z-score between -1.0 and -2.0 in any area assessed by DXA or increased radiolucency reported by
an attending radiologist on radiograph, computed tomography, or magnetic resonance imaging.
Osteoporosis
Osteoporosis: Z-score less than -2.0 in any area assessed by DXA and/or non-traumatic fracture.
13-TLEC Case Report Forms
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Exam (Baseline, Day 30, Day 100, Day 180, 1 year, and 2 year visits)
Form notes
The DXA scan question is visible for the Baseline, 1 year and 2 year visits. Based on the answer the DXA
and/or Radiograph form will appear in the visit folder. The values for Karnofsky and Lansky will appear based
on the value in the scale question. On the Baseline visit an edit check will fire if the value is <60 (exclusion
criterion).
Ranges
Field Units (standard unit) Range – listed in the help text
Height in
cm (standard)
63 – 213 cm
25-83 in
Weight lbs
kg (standard)
1 – 250 kg
3 - 551 lbs
Waist circumference in
cm (standard)
20 – 200 cm
7 – 79 in
Systolic blood pressure Fixed unit: mm Hg 50 - 200
Diastolic blood pressure Fixed unit: mm Hg 20 - 125
13-TLEC Case Report Forms
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Karnofsky/Lansky dynamic search list
UserDataString CodedData
Karnofsky <K> 100 Normal; no complaints; no evidence of
disease 100K
90 Able to carry on normal activity 90K
80 Normal activity with effort 80K
70 Cares for self; unable to carry on normal
activity or to do active work 70K
60 Requires occasional assistance but is able
to care for most needs 60K
50 Requires considerable assistance and
frequent medical care 50K
40 Disabled; requires special care and
assistance 40K
30 Severely disabled; hospitalization
indicated, although death not imminent 30K
20 Very sick; hospitalization necessary 20K
10 Moribund; fatal process progressing
rapidly 10K
Lansky <L> 100 Fully active 100L
90 Minor restriction in physically strenuous
play 90L
80 Restricted in strenuous play, tires more
easily, otherwise active 80L
70 Both greater restrictions of, and less time
spent in, active play 70L
60 Ambulatory up to 50% of time, limited
active play with assistance / supervision 60L
50 Considerable assistance required for any
active play; fully able to engage in quiet play 50L
40 Able to initiate quiet activities 40L
30 Needs considerable assistance for quiet
activity 30L
20 Limited to very passive activity initiated by
others (e.g., TV) 20L
10 Completely disabled, not even passive play 10L
13-TLEC Case Report Forms
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Medications (Baseline, Day 100, Day 180, 1 year, and 2 year visits)
Form notes This form is available in Baseline and follow up visit folders. The categories are defaulted to show with the
expectation that ‘Taking?’ will be answered for each. The rest of each line is dependent on this question.
Help text Help text present in the header: “Medications entered should be prescribed, ongoing medications. Do not
include medications given only as needed for a symptom/issue.”
13-TLEC Case Report Forms
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Form notes The form is present for the Baseline and follow up visits but the questions asked vary depending on visit.
Help text Each value that includes a range has help text that lists the expected ranges. In addition, the last 5 lab values
have the following help text.
Ranges
Field Units (standard unit) Format Range Visits Urine protein: mg/dL NNNNN.N 0 – 20,000 All (Baseline, Day 30, Day
100, Day 180, 1 year and 2
year)
Urine albumin: mg/dL(standard)
mg/L NNN.N 0 – 500 All
13-TLEC Case Report Forms
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Field Units (standard unit) Format Range Visits
Urine microalbumin: mg/dL(standard)
mg/L NNN.N 0 – 500 All
Measured GFR or creatinine clearance:
mL/min/1.73 m2 NNN (no
decimals)
0 – 200 Baseline, 1 year, 2 year
Serum creatinine: mg/dL NN.NN 0.3 – 10 All Urine creatinine: mg/dL NNN.NN 0 – 600 All Cystatin C: mg/L N.NN 0.2 – 3.0 All BUN: mg/dL NN.NN 1 – 30 All 25-OH Vitamin D: nmol/L (standard)
ng/mL
NNN.N 0 – 999 Baseline, Day 100, 1 year
and 2 year
Parathyroid hormone: pg/mL (standard)
pmol/L
NNN.N 0 – 999 Baseline, Day 100, 1 year
and 2 year
Calcium: mg/dL NN.N 5 – 20 Baseline, Day 100, 1 year
and 2 year Serum osteocalcin: μg/L (equivalent
to ng/mL) –
standard
nmol/liter
NNN.NN 0.5 – 100 All but Day 180
Urine N-telopeptide: nmol bone collagen equivalents/mmol creatinine
NNNN 5 – 3000 All but Day 180
Bone specific alkaline phosphatase:
µg/L NNN.N 10 – 99 All but Day 180
Triglycerides mg/dL NNN 0 – 999 All but Day 180
HDL
mg/dL
mmol/L (standard)
NNN.N 0.3 – 5
mmol/L
All but Day 180
LDL mg/dL
mmol/L (standard)
NNN.N 0.3 – 5
mmol/L
All but Day 180
Insulin pmol/L
mcIU/ml
(standard)
NNN.N 0 – 50
mcIU/ml
All but Day 180
Blood glucose mg/dL NNN 30 – 999 All but Day 180
Unit dictionary Questions CodedUnit UnitString Standard Formula
Height and waist circumference
CM cm X
IN in value / 2.54
Weight KG kg X
LBS lbs value * 2.2046
HDL and LDL MG_DL mg/dL
MMOL_L mmol/L X value / 0.0259
Vitamin D NMOL_L nmol/L X
NG_ML ng/mL value / 2.496
Parathyroid PG_ML pg/mL value * 0.105
PMOL_L pmol/L X
Osteocalcin MICROGRAM_L
μg/L (equivalent to ng/mL) X
NMOL_L nmol/liter value * 0.171
Insulin pmol pmol/L value / 0.143988
13-TLEC Case Report Forms
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mcIU mcIU/ml
Urine albumin and Urine microalbumin
mgdl mg/dL X
mgl mg/L value * 10
DXA scan (Baseline, 1 year, and 2 year visits)
Form notes This form is available at the Baseline, 1 year, and 2 year visits if the trigger question on the Exam form is Yes.
Radiograph
Form notes This form is available at the Baseline, 1 year, and 2 year visits if the trigger question on the Exam form is Yes.
13-TLEC Case Report Forms
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Log Line expanded
Form notes The GVHD prevention questions are checkboxes where multiple values can be selected. The choices are based
on the protocol values. The three indented questions for radiation will be available when the form is saved if
Radiation therapy is Yes.
Conditioning agent dynamic search list The agents available to select for Conditioning Regimen are listed in the table.
Agent Agent specify Other, specify
ALG, ALS, ATG, ATS
Anthracycline
Daunorubicin
Doxorubicin (Adriamycin)
Idarubicin
Other anthracycline Text field required
Bleomycin (BLM, Blenoxane)
Busulfan (Myleran)
Carboplatin
Cisplatin (Platinol, CDDP)
Cladribine (2-CdA, Leustatin)
Corticosteroids Methylprednisone (Solu-Medrol)
Prednisone
Dexamethasone
Other corticosteroid Text field required
Cyclophosphamide (Cytoxan)
Cytarabine (Ara-C)
Etoposide (VP-16, VePesid)
13-TLEC Case Report Forms
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Agent Agent specify Other, specify
Fludarabine
Ifosfamide
Intrathecal therapy
(chemotherapy)
Intrathecal cytarabine (IT Ara-C)
Intrathecal methotrexate (IT MTX)
Intrathecal thiotepa
Other intrathecal drug Text field required
Melphalan (L-Pam)
Mitoxantrone (Novantrone)
Radio labeled Mab Tositumomab (Bexxar) *
Ibritumomab tiuxetan (Zevalin) *
Other radio labeled mAb Text field required
Monoclonal antibody Alemtuzumab (Campath)
Rituximab (Rituxan, anti CD20)
Gemtuzumab (Mylotarg, anti
CD33)
Other Mab Text field required
Nitrosourea Carmustine (BCNU)
CCNU (Lomustine)
Other nitrosourea Text field required
Paclitaxel (Taxol, Xyotax)
Teniposide (VM26)
Thiotepa
Treosulfan
Tyrosine kinase inhibitors
Other drug Text field required
13-TLEC Case Report Forms
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Transplant Form (Transplant visit)
Form notes The Match Type questions are based on the Product type selected and appear once the form is saved.
13-TLEC Case Report Forms
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Post Transplant Follow up (Day 30, Day 100, Day 180, 1 year, and 2 year visits)
13-TLEC Case Report Forms
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Form notes Indented questions are visible based on the answer to the previous question and available when the form is
saved. If either GVHD question is answered Yes the corresponding GVHD form will appear within the visit
folder.
13-TLEC Case Report Forms
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Medical Conditions (Day 100, Day 180, 1 year and 2 year visits)
Help text
13-TLEC Case Report Forms
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Form notes This form is made available based on a trigger question on the Post Transplant Follow Up form.
Therapy dropdown choices:
ALS, ALG, ATS, ATG
Corticosteroids (systemic)
Corticosteroids (topical)
Cyclosporine (CSA) (Sandimmune, Neoral) ECP (extra-corporeal photopheresis)
FK 506 (Tacrolimus, Prograf)
In vivo monoclonal antibody
Anti CD 25 (Zenapax, Daclizumab, AntiTAC)
Campath
Etanercept (Enbrel)
Infliximab (Remicade)
Other in vivo monoclonal antibody
In vivo immunotoxin Methotrexate (MATX) (Amethopterin)
Mycophenolate mofetil (MMF) (CellCept)
Sirolimus (Rapamycin, Rapamune)
Ursodiol
Blinded randomized trial
Other agent
13-TLEC Case Report Forms
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Form notes This form is made available based on a trigger question on the Post Transplant Follow Up form.
Therapy dropdown choices:
ALS, ALG, ATS, ATG
Azathioprine
Corticosteroids (systemic)
Corticosteroids (topical) Cyclosporine (CSA) (Sandimmune, Neoral)
ECP (extracorporeal photopheresis)
Hydroxychloroquine (Plaquenil)
Etretinate
FK 506 (Tacrolimus, Prograf)
In vivo monoclonal antibody Anti CD 25 (Zenapax, Daclizumab, AntiTAC)
Campath
Etanercept (Enbrel)
Infliximab (Remicade)
Other in vivo monoclonal antibody
Lamprene (Clofazimine) Mycophenolate mofetil (MMF) (CellCept)
Pentostatin
PUVA (Psoralen and UVA)
Sirolimus (Rapamycin, Rapamune)
Thalidomide
Ursodiol
Blinded randomized trial
13-TLEC Case Report Forms
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Other agent
Unanticipated Problem
Form notes This is an unscheduled form available from the subject home page as needed.