crf v1.0 final 03 ralexar therapeutics, inc. v1 day -28 to 0 page 1€¦ · crf v1.0 final 03 1...

CRF v1.0 FINAL 03

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Protocol ALX-101-ATOP-204

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Ralexar Therapeutics, Inc.

Subject ID

-Site Subject

1

Page is ready for submission EDC:

DD MMM YYYY

Informed ConsentDemographics

Has the subject or subject’s parent or legal guardian signed an IRB approved Informed Consent form?

For subjects under the legal age of consent in the state/province they are enrolled, did the subject sign an IRB approved Assent form?

Date & Time of Informed Consent/ Assent Form

If No, do not proceed with study procedures

If No, do not proceed with study procedures

Informed Consent

HH MM

:Time(24hrs)

0 NO 1 YES

0 NO 1 YES

9 N/A

Date of Visit

DD MMM YYYY

V1

Date of Birth

Sex at Birth

Race(Check one)

(Check one if RACE is checked WHITE)

1 White* 2 African American

3 Asian 4

American Indian5

*Ethnicity 1

9

Hispanic or Latino

Not willing to provide

2Not Hispanic or Latino

1 Male 2 Female

Demographics

6 Alaskan Native

Native Hawaiianor Pacific Islander

9 Other (specify)DD MMM YYYY

Childbearing Potential (WOCBP)

9

1

9

2

MALE

Postmenopausal

Other (specify):

Surgically Sterile

Is the subject a woman of childbearing potential?

If NO, check the reason that applies

1 YES

0 NO

Subject must be ≥ 12 Yrs oldNOTE:

(Check one)1 2 3 4 5 6

Fitzpatrick Skin Type

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“X” the box if page intentionally left blank Page is ready for submission EDC:

Eligibility(Inclusion Criteria)

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To qualify for study participation, ALL Inclusion Criteria MUST be answered YES or N/AInclusion Criteria

0 NO 1 YES

9 N/A

0 NO 1 YES

9 N/A

0 NO 1 YES

9 N/A

V1

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

Subject is at least 12 years of age at the time of consent.

Subject has a clinical diagnosis of stable AD confirmed using the Hanafin and Rajka criteria

Subject has at least a 6-month history of atopic dermatitis and had no significant flares in atopic dermatitis for at least 4 weeks before Visit 1 (screening) (information obtained from medical chart or subject’s physician or directly from the subject).

Subject must have active features of AD covering a minimum of 2% body surface area (BSA) (excluding scalp, face, genitals, palmar aspect of hands and plantar aspect of feet) at Visit 2 (baseline).

Subject has moderate AD, defined as vIGA-AD™ score of 3 (“moderate”), at Visit 2 (baseline).

Subject has an EASI score ≥ 5 at Visit 2 (baseline)

Subject has been using an emollient (except those containing urea) daily for at least 1 week prior to Visit 2 (baseline), except on visit day before the visit. Subject agrees to continue using that emollient, daily at the same frequency, on non-treated areas, throughout the study but not the day of visits prior to the visit scheduled time.

Female subject of childbearing potential involved in any sexual intercourse that could lead to her pregnancy, must have a negative serum pregnancy test at Visit 1, a negative urine pregnancy test at Visit 2 (baseline) and agree to use an approved highly effective contraceptive method for the entire study and up to 4 weeks following the final dose of study medication unless they are surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or in menopausal state for at least one year prior to screening (Visit 1)

Female subject of childbearing potential agrees to use an approved highly effective method of contraception through study participation for 4 weeks following the final dose of study medication

Subject is in good general health and free of any known disease state or physical condition which, in the investigator’s opinion, might impair evaluation of the AD being treated or which exposes the subject to an unacceptable risk by study participation

Subject is willing and able to follow all study instructions and to attend all study visits

Subject is able to comprehend and willing to sign an Informed Consent Form (ICF)/Assent Form (AF)

Parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures as applicable; subject has the ability to give assent in the Assent Form (AF)

Informed Consent Form (ICF)/Assent Form (AF) must be obtained prior to initiation of any protocol-related procedures.

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Eligibility(Exclusion Criteria)

Subject has spontaneously improving or rapidly deteriorating AD

Subject has clinically infected AD

Subject has any signs or symptoms associated with topical AD therapy which, in the investigator’s opinion, might impair evaluation of the AD being treated or which exposes the subject to an unacceptable risk by study participation

Subject has any clinically significant laboratory abnormality, medical condition or physical/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results

Subjects with a past history of cancer or lymphoproliferative disease within 5 years prior to Visit 2 (baseline) (subjects with successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded)

Subject is known to have immune deficiency or is immunocompromised

Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or infection with human immunodeficiency virus)

Subject had major surgery within 8 weeks prior to Visit 2 (baseline) or has a major surgery planned during the study.

Topical medications, including but not limited to, topical corticosteroids, crisaborole and any other topical phosphodiesterase-4 inhibitor, calcineurin inhibitors, tars, bleach, antimicrobials, medical devices and bleach bath within 2 weeks prior to Visit 2 (baseline)

Subject has used any non-medicated topical product (e.g., lotions, gels, creams, ointments) in the planned treatment area 4 hours prior to Visit 2 (baseline)

Subject has used the following systemic treatments (other than biologics) that could affect atopic dermatitis less than 4 weeks prior to Visit 2 (baseline) (e.g., retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide [hydroxyurea], azathioprine, oral/injectable corticosteroids) within 4 weeks prior to Screening. Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed.

Subject has used any systemic antibiotics within 2 weeks prior to Visit 2 (baseline)

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0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

To qualify for study participation, ALL Exclusion Criteria MUST be answered NOExclusion Criteria

V1

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Eligibility(Exclusion Criteria)

Subject has used hydroxyzine or diphenhydramine within 1 week prior to Visit 2 (baseline), unless on a stable dose.

Subject has used topical doxepin within 1 week prior to Visit 2 (baseline).

Subject has used topical products containing urea within 1 week prior to Visit 2 (baseline)

Subject has used or is planning to use any phototherapy (e.g., UVA/UVB therapy, or PUVA therapy), excessive natural or artificial ultraviolent radiation (e.g., sunlight, tanning beds) which, in the investigator’s opinion, might affect AD within 4 weeks prior to Visit 2 (baseline)

Biologic therapies (e.g., Dupilumab) within 12 weeks or 5 half-lives prior to Visit 2 (baseline)

Subject has a history of sensitivity to any of the ingredients in the study medications

Subject has any known concomitant dermatologic or medical condition which, in the investigator’s opinion, might impair evaluation of the areas of AD being treated or which exposes the subject to an unacceptable risk by study participation (e.g., psoriasis, rosacea, lichen planus, lichen simplex chronicus,…)

Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.

Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Visit 2 (baseline)

Subject has participated in a nonbiological investigational drug trial in which administration of an investigational study medication occurred within 4 weeks prior to Visit 2 (baseline)

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0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

To qualify for study participation, ALL Exclusion Criteria MUST be answered NOExclusion Criteria (Cont.)

V1

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.

Medical andSurgical History

V1

Report all medical conditions and disease states that require therapy or that, in the opinion of the investigator, are relevant to the subject’s study participation. For female subjects who are NOT OF CHILDBEARING POTENTIAL report the reason. For each reported condition/disease enter the appropriate code number from below followed by a description of the condition/disease.

CODE Diagnosis

ATOPIC DERMATITIS01

LINE

#

Onset Date

Onset Date

Onset Date

Onset Date

Onset Date

Onset Date

Onset Date

Resolution

Resolution

Resolution

Resolution

Resolution

Resolution

Resolution

Onset and Resolution Dates(DD MMM YYYY)

Ongo

ing (X

)

Body System Code Body System Code Body System Code

01: Skin 02: Central nervous system 03: Ophthalmologic 04: Ear, nose, throat 05: Respiratory 06: Gastrointestinal

07: Hepatic08: Renal09: Cardiovascular10: Hematologic 11: Genitourinary 12: Endocrine/Lymphatic

13: Musculoskeletal 14: Systemic infection 15: Drug allergy 16: Substance abuse 17: Psychiatric 99: Other

If additional Medical History pages are required, click "Repeat Page" EDC:

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Physical ExamVital Signs

Physical Examination

Sys.N

um

Body System Not Done Normal Abnormal

NCSAbnormal

CSDescribe Abnormality

or comment if not done

1 Gen. Appearance 1 2 3

2 HEENT 1 2 3

3 Respiratory 1 2 3

4 Cardiovascular 1 2 3

5 Abdominal 1 2 3

6 Extremities 1 2 3

7 Musculoskeletal 1 2 3

8 Lymphatic 1 2 3

9 Skin 1 2 3

10 Neurological 1 2 3

Record clinically significant abnormalities in Medical History

Not Done (explain on comments page)

Vital Signs

Height inches

Blood Pressuresystolic diastolic

mm Hg Pulse rate

Respiratory rate

beats/min

breaths/minTemperature

˚F

Weight lbs

If systolic pressure > 140mmHg, is it clinically relevant?If diastolic pressure > 90mmHg, is it clinically relevant?

(If YES to any, provide Medical History)0 NO 1 YES

0 NO 1 YES

Were Vital Signs collected as directed? 0 NO 1 YES

V1

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V1

SPT, PhotoLab Samples

Pregnancy Testing (SPT) IF POS: DO NOT ENROLL

Was a Serum Pregnancy Test performed? Test Result 1 POS0 NEG0 NO 1 YES 9 N/A

Were Laboratory samples collected as directed?

If YES, date of blood draw

(If NO, explain on Comments page)0 NO 1 YES

Laboratory Samples

MMMDD YYYY

Standardized Photography

Were photographs taken per instructions? 0 NO 1 YES

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V1

BSA, EASIvIGA

Body Surface Area of AD (BSA)

%


Percentage of total Body Surface Area (BSA) of Atopic Dermatitis:

Grade Descriptor

0CLEAR: Noinflammatory signs of atopic dermetitis (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Post-inflamatory hyperpigmentation and/or hypopigmentation may be present

1 ALMOST CLEAR: Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting.

2 MILD: Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting.

3 MODERATE: Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present.

4 SEVERE: Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread in extent. Oozing and crusting may be present.

Not Done (explain on comments page) Investigator Global Assessment (vIGA)

Eczema Area and Severity Index (EASI) Not Done (explain on comments page)

EASI Calculator

Erythema (Redness)

Induration (Thickness)

Excoriation (Scratching)

Licheni-fication

SeverityScore Area Score Multiplier Region Score

Head/Neck = X X 0.1 =

Upper Limbs = X X 0.2 =

Trunk = X X 0.3 =

Lower Limbs =

X X 0.4 =

EASI Score

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DD MMM YYYY

V2Date of Visit

ComplianceUPT, Labs,

Photo

Were fasting laboratory samples (8-12 Hrs) collected at this visit as directed? 0 NO 1 YES

Laboratory Samples

Standardized Photography/Body Charts

Were photographs taken per instructions?

Was a paper version of the body map completed per instructions?

0 NO 1 YES

0 NO 1 YES

Review the following items for the subject and document as appropriate:• New medical history or changes to ongoing conditions (Page 4)• New concomitant therapies or changes to ongoing concomitant therapies (Page 902)

Compliance with Study Criteria (since Visit 1)

Has the subject complied with all study requirements, followed all study instructions since Visit 1 and continue to meet the entrance criteria?

0 NO 1 YES

IF NO: DO NOT ENROLL

Pregnancy Testing (UPT) IF POS: DO NOT ENROLL

Was a Urine Pregnancy Test performed? Test Result 1 POS0 NEG0 NO 1 YES 9 N/A

PRIOR TO TREATMENT

Visit 2 (Study Day 1)

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Sys.N

um


NCSAbnormal




2 HEENT 1 2 3

3 Respiratory 1 2 3


5 Abdominal 1 2 3

6 Extremities 1 2 3


8 Lymphatic 1 2 3

9 Skin 1 2 3


Record clinically significant abnormalities in Medical History


Vital Signs


mm Hg Pulse rate

Respiratory rate

beats/min


˚F


(If YES, provide Medical History)0 NO 1 YES

0 NO 1 YES


PRIOR TO TREATMENT

V2

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PRIOR TO TREATMENT

NRS,SCORAD

SCORAD (Scoring Atopic Dermatitis)

%


Head and Neck 10%

Trunk

(inc

l Axil

la &

Groin

) 30%

Both Upper Extremities 20%

Both Lower Extremities (incl. Buttocks) 40%

Criterion Intensity (0-3)

Erythema

Papulation / Oedema

Oozing / Crusting

Excoriation

Lichenification/Inflammation

Dryness

Total Score

Symptom Scale of 0-10

Sleep Loss

Itching

Total Score

Total SCORAD score calculation (A/5+7B/2+C)

Score out of 103

B) INTENSITY (average representative area) C) SUBJECTIVE SYMPTOMS0 = Absent 1 = Mild2 = Moderate 3 = Severe

Ask the subject to indicate on a scale of 0-10 the average value for the last 3 days/nights.

A) EXTENTIndicate the percentage area involved (FULL BODY BSA)

V2


0 100 1 2 3 4 5 6 7 8 9 10

WORST IMAGINABLE ITCHNO ITCH

Numeric Rating Scale (NRS)

Report 1 integer that best describes the worst severity of pruritus over the previous 24 hrs.

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BSA, EASIvIGA

PRIOR TO TREATMENT

V2

Body Surface Area of AD (BSA)

%


Percentage of total Body Surface Area (BSA) of Atopic Dermatitis:

Grade Descriptor








Total body surface area at Baseline must be at least 2% for study eligibilityNOTE:

EASI Score at Baseline must be ≥5 for study eligibilityNOTE:

vIGA at Baseline must be 3 for study eligibilityNOTE:

EASI Calculator

Erythema (Redness)



Licheni-fication




Trunk = X X 0.3 =

Lower Limbs =

X X 0.4 =

EASI Score

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RandomizationTreatment

Eligibility

Is the subject eligible for randomization to study medication?

Subject Kit number:

0 NO 1 YES

NOTE:

EDC: If Eligibility is marked YES the subject can be randomized:1. Close the eCRF2. Click the "Enroll for Treatment" button3. Enter the assigned Kit Number in the following dialog4. Kit Number will appear in the box at left

For Ineligible Subjects:• Submit all Visit 2 pages • Complete and submit the End of Study page • Discharge ineligible subjects per protocol instructions.

V2

Initial Study Medication Treatment

Dispense Study Medication tubes to subject. Record dispensed weights on Page 903 (Drug Accountability)

Provide the subject with the subject instruction sheet and diary

Record any Adverse Events on Page 901 (AE logging page)

NOTES:

IF NO: DISCONTINIUE SUBJECT PER PROTOCOL

Was the subject monitored for at least 20 minutes after the Treatment Completion Time?

Treatment Completion Time

0 NO 1 YES

0 NO 1 YES

HH MM

:Time(24hrs)

Was study medication applied to the treatment areas at this Visit?

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DD MMM YYYY

Date of VisitSubject Status

Vital Signs

V3

Review the following items for the subject and document as appropriate:• New adverse events or changes to ongoing adverse events (Page 901)• New concomitant therapies or changes to ongoing concomitant therapies (Page 902)• Confirm the subject continues to comply with study restrictions and instructions• Collect the Subject Diary• Collect and weigh returned tubes. Record return weights on Page 903 (Drug Accountability)

Vital Signs


mm Hg Pulse rate

Respiratory rate

beats/min


˚F


(If YES, record as Adverse Event)0 NO 1 YES

0 NO 1 YES


Visit 3 (Study Day 15 ± 2)

Body Charts

Was a paper version of the body map completed per instructions? 0 NO 1 YES

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V3

NRS,SCORAD


%


Head and Neck 10%

Trunk

(inc

l Axil

la &

Groin

) 30%




Erythema

Papulation / Oedema

Oozing / Crusting

Excoriation


Dryness

Total Score


Sleep Loss

Itching

Total Score


Score out of 103





0 100 1 2 3 4 5 6 7 8 9 10




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V3

EASIvIGA

Grade Descriptor








EASI Calculator

Erythema (Redness)



Licheni-fication




Trunk = X X 0.3 =

Lower Limbs =

X X 0.4 =

EASI Score

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Treatment

Study Medication Treatment

NOTES:




0 NO 1 YESWas study medication applied to the treatment areas at this Visit?

V3

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DD MMM YYYY

Date of VisitSubject Status

Vital Signs, Labs,UPT, Photo

V4

Vital Signs


mm Hg Pulse rate

Respiratory rate

beats/min


˚F


0 NO 1 YES

0 NO 1 YES


Were laboratory samples (non-fasting) collected at this visit as directed? 0 NO 1 YES

Laboratory Samples

(If YES, record as Adverse Event)


Pregnancy Testing (UPT)





0 NO 1 YES

0 NO 1 YES


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V4

NRS,SCORAD


%


Head and Neck 10%

Trunk

(inc

l Axil

la &

Groin

) 30%




Erythema

Papulation / Oedema

Oozing / Crusting

Excoriation


Dryness

Total Score


Sleep Loss

Itching

Total Score


Score out of 103





0 100 1 2 3 4 5 6 7 8 9 10




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V4

EASIvIGA

Grade Descriptor








EASI Calculator

Erythema (Redness)



Licheni-fication




Trunk = X X 0.3 =

Lower Limbs =

X X 0.4 =

EASI Score

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V4

Treatment


NOTES:





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DD MMM YYYY

V5Date of Visit

Subject StatusVital Signs, UPT,

Labs, Photo

Vital Signs


mm Hg Pulse rate

Respiratory rate

beats/min


˚F


(If YES, record as Adverse Event)0 NO 1 YES

0 NO 1 YES






0 NO 1 YES

0 NO 1 YES


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V5

NRS,SCORAD


%


Head and Neck 10%

Trunk

(inc

l Axil

la &

Groin

) 30%




Erythema

Papulation / Oedema

Oozing / Crusting

Excoriation


Dryness

Total Score


Sleep Loss

Itching

Total Score


Score out of 103





0 100 1 2 3 4 5 6 7 8 9 10




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V5

EASIvIGA

Grade Descriptor








EASI Calculator

Erythema (Redness)



Licheni-fication




Trunk = X X 0.3 =

Lower Limbs =

X X 0.4 =

EASI Score

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V5

Treatment


NOTES:





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DD MMM YYYY

V6Date of Visit

Subject StatusUPT, Labs, Photo

Were fasting laboratory samples (8-12 Hrs) collected at this visit as directed? 0 NO 1 YES

Laboratory Samples

Visit 6 (Study Day 57 ± 4) / Early Termination






0 NO 1 YES

0 NO 1 YES


Early Termination

Is this an Early Study Termination visit?

If YES, enter all available data and complete the End of Study page 200. Mark empty pages as "intentionally blank". Comments need not necessarily be provided for missing data

0 NO 1 YES

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V6



Sys.N

um


NCSAbnormal




2 HEENT 1 2 3

3 Respiratory 1 2 3


5 Abdominal 1 2 3

6 Extremities 1 2 3


8 Lymphatic 1 2 3

9 Skin 1 2 3


Record clinically significant abnormalities in Adverse Events


Vital Signs


mm Hg Pulse rate

Respiratory rate

beats/min


˚F


(If YES, provide Adverse Event)0 NO 1 YES

0 NO 1 YES


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V6

NRS,SCORAD


%


Head and Neck 10%

Trunk

(inc

l Axil

la &

Groin

) 30%




Erythema

Papulation / Oedema

Oozing / Crusting

Excoriation


Dryness

Total Score


Sleep Loss

Itching

Total Score


Score out of 103





0 100 1 2 3 4 5 6 7 8 9 10




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Initials

F M L


Subject ID

-Site Subject

29


V6

EASIvIGA

Grade Descriptor








EASI Calculator

Erythema (Redness)



Licheni-fication




Trunk = X X 0.3 =

Lower Limbs =

X X 0.4 =

EASI Score

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Page 101Unscheduled Visit

Initials

F M L


Subject ID

-Site Subject

101


DD MMM YYYY

UVDate of Unscheduled Visit

Subject StatusUPT, Labs, Photo

Review the following items for the subject and document as appropriate:• New adverse events or changes to ongoing adverse events (Page 901)• New concomitant therapies or changes to ongoing concomitant therapies (Page 902)

Please mention on comments page if laboratory samples were fasting or non-fasting at UV

Were laboratory samples collected at this visit as directed? 0 NO 1 YES

Laboratory Samples

Reason for Unscheduled Visit:






0 NO 1 YES

0 NO 1 YES

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Page 102Unscheduled Visit

Initials

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Subject ID

-Site Subject

102


UV


Sys.N

um


NCSAbnormal




2 HEENT 1 2 3

3 Respiratory 1 2 3


5 Abdominal 1 2 3

6 Extremities 1 2 3


8 Lymphatic 1 2 3

9 Skin 1 2 3


Record clinically significant abnormalities in Adverse Events

Not Done

Vital Signs


mm Hg Pulse rate

Respiratory rate

beats/min


˚F


(If YES, provide Adverse Event)0 NO 1 YES

0 NO 1 YES



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Page 200End of Study

Initials

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Subject ID

-Site Subject

200


End of Study

EOS

: Complete sections below

(e.g. completion date, withdrawal date, last follow-up)

: Subject was ineligible for treatment (screening failure)

Did the subject discontinue the study prematurely?

Was the subject randomized to receiveStudy Medication Treatment?

Complete for randomized subjects only:

Complete for all subjects:

Study Termination

Enter date of last contact

Enter date of last Study Medication use

If YES, check one box to indicate the primary reason for discontinuation:

DD MMM YYYY

DD MMM YYYY

0 NO 1 YES

0 NO

1 YES

1

AE/SAE (Provide the primary AE number)2

3

4

5

9

Protocol violation (provide detail below)

Lost to Follow-Up (report last contact date above)

Withdrew consent (Investigator confirms that an AE was not the reason for withdrawal)

Pregnancy (inform Sponsor and report pregnancy details)

Other (explain in comment below)

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Page 201End of Study

Initials

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Subject ID

-Site Subject

201


Investigator’s Sign-Off Date

I have reviewed the entries on this subject's Case Report Forms and concur with all the observations and recorded information herein.

Once this page has been signed off, the entire E-CRF will be locked from further changes. Remove the sign-off mark if changes have to be made and re-sign when appropriate.

Please await instruction from your CRA before signing off.

InvestigatorSign-Off

DD MMM YYYY

Investigator Sign-Off

EDC:

EOS

CRF v1.0 FINAL 03

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Page 901Adverse Events Log

Initials

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Subject ID

-Site Subject

901


.

Adverse Events

Adverse Event Term Onset and Resolution Dates(MM DDD YYYY)

AE Severity Relationship toStudy Medication

Action taken regardingStudy Medication

1 = Mild2 = Moderate3 = Severe

1 = Dose not changed2 = Dose reduced3 = Dose interrupted4 = Drug Withdrawn9 = Unknown

1 = Not Related2 = Related

AE Outcome

1 = Recovered/Resolved2 = Not Recovered/Resolved3 = Recovered/Resolved with Sequelae4 = Fatal5 = Unknown

AE Outcome AE Severity Relationship to Study Med.

Action taken regarding study medication

Is this event an SAE? If YES, complete an SAE form per protocol

(Active/Deleted)

If you delete an AE record, do NOTre-use the page for a different AE

0 NO 1 YES

Was therapy required? If YES, report on Concomitant Therapies Form

If YES, report on End of Study page

0 NO 1 YES

Subject discontinued due to AE? 0 NO 1 YES

Is this a cutaneous AE?

If YES, does the AE involve a Treatment Area?

If YES, indicate body area: 0 NO 1 YES

0 NO 1 YES

Onset

Resolution

Ongoing

LOG

AE NUMBER

AE STATUS

If additional Adverse Events pages are required, click "Repeat Page" EDC:

EDC: This number will be entered automatcally

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Page 902Concomitant Therapies Log

Initials

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Subject ID

-Site Subject

902


.LOG

If additional CT pages are required, click "Repeat Page" EDC:

Is this therapy associated with an Adverse Event?




If YES, provide AE Number




0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

0 NO 1 YES

Prior & ConcomitantTherapies

Therapy Generic Name(If a combination drug, use Trade name)

Start & Stop Dates(DD MMM YYYY)LI

NE #

Start

Start

Start

Start

Stop

Stop

Stop

Stop

ONGOING

ONGOING

ONGOING

ONGOING

Therapy:

Therapy:

Therapy:

Therapy:

Indication:

Indication:

Indication:

Indication:

Non-medication

Non-medication

Non-medication

Non-medication

0 NO 1 9YES UnknownIs this therapy prohibited per protocol?




Dose

Dose

Dose

Dose

Units

Units

Units

Units

Frequency

Frequency

Frequency

Frequency

Route

Route

Route

Route

Other

Other

Other

Other

Other

Other

Other

Other

Other

Other

Other

Other

Unit Codes Route Codes Frequency Codes1 = mg 4 = mcg2 = mL 5 = gram3 = tablets 6 = meq 9 =Other, specify in field

1 = oral 4 = IV2 = topical 5 = IM3 = Nasal 6 = SC 9 =Other, specify in field

1 = QD 4 = Once2 = BID 5 = QID3 = TID 6 = Hourly 9 =Other, specify in field

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Page 903Drug Accountability Log

Initials

F M L


Subject ID

-Site Subject

903


Drug Accountability

(Usage/Dispensations)

• Record all weights to 0.01 grams• Record unused tubes by checking "Tube not Used"

LOG

If additional Accountability pages are required, click "Repeat Page" EDC:

Tube Number Details of Usage (Dispensed/Returned)

1Tube Dispensed

Tube Returned

Tube Not Used

Not returned

Date

Date

Weight

Weight

.

.

2Tube Dispensed

Tube Returned

Tube Not Used

Not returned

Date

Date

Weight

Weight

.

.

3Tube Dispensed

Tube Returned

Tube Not Used

Not returned

Date

Date

Weight

Weight

.

.

4Tube Dispensed

Tube Returned

Tube Not Used

Not returned

Date

Date

Weight

Weight

.

.

5Tube Dispensed

Tube Returned

Tube Not Used

Not returned

Date

Date

Weight

Weight

.

.

6Tube Dispensed

Tube Returned

Tube Not Used

Not returned

Date

Date

Weight

Weight

.

.

7Tube Dispensed

Tube Returned

Tube Not Used

Not returned

Date

Date

Weight

Weight

.

.

8Tube Dispensed

Tube Returned

Tube Not Used

Not returned

Date

Date

Weight

Weight

.

.

9Tube Dispensed

Tube Returned

Tube Not Used

Not returned

Date

Date

Weight

Weight

.

.

10Tube Dispensed

Tube Returned

Tube Not Used

Not returned

Date

Date

Weight

Weight

.

.

(DD MMM YYYY)

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Page 904Comments

Initials

F M L


Subject ID

-Site Subject

904


.

Comments

Comment

NOTE: Please enter an item or line number where applicable

Item/Line Number(If applicable)

(If applicable)

(If applicable)

(If applicable)

(If applicable)

Comment by:(Initials)





Comment

Item/Line Number

Comment

Item/Line Number

Comment

Item/Line Number

Comment

Item/Line Number

CRF Page Number

CRF Page Number

CRF Page Number

CRF Page Number

CRF Page Number

DD MMM YYYY

DD MMM YYYY

DD MMM YYYY

DD MMM YYYY

DD MMM YYYY

LOG

If additional Comments pages are required, click "Repeat Page" EDC:

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