TOPPIC -Annotated CRF

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TOPPIC STUDY – Annotated CRF pages

Pre-screening

Annotations Screen Label Database field

Gender tblPrescreening.Gender

Date of Birth tblPrescreening.DoB

If this is a referral from………….. tblPrescreening.Referral

Proceed to visit -1 tblPrescreening.ProceedToVisit

Reason for making this patient a non-recruit tblPrescreening.NonRecruitReason

If ineligible, Ineligible reason tblPrescreening.IneligibleReason

If declined, Declined reason tblPrescreening.DeclinedReason

Any other details tblPrescreening.OtherDetails

Decision Date tblPrescreening.DecisionDate

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Visit-1 Inclusion/Exclusion


Visit Date tblVisitMin1.VisitDate

INCLUSION CRITERIA

2.Establishment of Crohns tblVisitMin1.Crohns

3.Resection within 3 months tblVisitMin1.Resection

Ileonic resection date tblVisitMin1.ResectionDate

Small bowel resection only? tblVisitMin1.SmallBowelOnly

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7.Screening consent form signed? tblVisitMin1.ScreeningConsent

EXCLUSION CRITERIA

2.Known intolerance to 6MP tblVisitMin1.IntoleranceSixMP

3.Pancreatitis assoc. with Azothyoprine tblVisitMin1.Pancreatitis

6.Stricturoplasty procedure alone tblVisitMin1.Stricturoplasty

11. History illicit drug or alcohol abuse in past year tblVisitMin1.DrugAlcAbuse

Is Subject breastfeeding? tblVisitMin1.Breastfeeding

SCREENING SAMPLES

Screening Consent date tblVisitMin1.ScreeningConsentDate

Samples Taken Date tblVisitMin1.SamplesDate

Samples Taken TPMT tblVisitMin1.SampleTPMT

Samples Taken Stool tblVisitMin1.SampleStool

TPMT Result tblVisitMin1.ResultTPMT

Positive Stool Result tblVisitMin1.ResultStool

Eligibility

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INCLUSION Criteria

1. At least 16 years of age

2. Established diagnosis of Crohn’s disease confirmed at recent resection tblVisitMin1.Crohns

3. Ileocolonic resection within three months tblVisitMin1.Resection tblVisitMin1.ResectionDate

4. No more than 100cm of bowel resected tblVisit2.ResectionLessThan

5. Able to start oral nutrition within first 2 post-op weeks tblVisit2.OralNutrition

6. Normal or heterozogenous TPMT tblVisitMin1.ResultTPMT

7. Has provided written informed consent tblVisit2.ConsentForm

8. Off antibiotics 2 weeks prior to randomisation tblVisit2.Antibiotics

1. Pregnant tblVisit2.ResultPregnancy

1. Breastfeeding tblVisitMin1.Breastfeeding

2. Known hypersensitivity to 6MP tblVisitMin1.IntoleranceSixMP

3. Pancreatitis associated with Azathioprine tblVisitMin1.Pancreatitis

4. Receiving experimental Crohns treatment in 4 weeks prior to study tblVisit2.CrohnsTreatment

5. Known to require further surgery tblVisit2.FurtherSurgery

6. Stricturoplasty procedure alone tblVisitMin1.Stricturoplasty

7. Presence of stoma tblVisitMin1.Stoma

8. Significant haematological, renal or hepatic dysfunction Derived from:tblVisit1.LFT; tblVisit1.Haem; tblVisit1.WBC; tblVisit1.Neutro;

tblVisit1.Platelets

9. Systemic infection tblVisit2.SystemicInfection

10. Diagnosis of colitis tblVisit2.Colitis

11. History of illicit drug or alcohol abuse tblVisitMin1.DrugAlcAbuse

12. Active or untreated malignancy tblVisitMin1.HistoryCancer

13. Presence of condition that places subject at unacceptable risk tblVisit2.UnacceptableRisk

14. Homozygous deficient for TPMT tblVisit1.ResultTPMT

15. Evidence of untreated post-op infection tblVisit2.UntreatedInfection

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Pre-randomisation blood test results

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Actual Date tblBloodSafetyResults.ActualDate

Alk. Phos tblBloodSafetyResults.AlkPhos

ALT tblBloodSafetyResults.ALT

GGT tblBloodSafetyResults.GGTSymbol tblBloodSafetyResults.GGT

Haematocrit tblBloodSafetyResults.Haematocrit

Haemoglobin tblBloodSafetyResults.Haemoglobin

Neutrophils tblBloodSafetyResults.Neutrophils

Platelets tblBloodSafetyResults.Platelets

WBC tblBloodSafetyResults.WBC

Red Cell count tblBloodSafetyResults.RedCellCount

MCV tblBloodSafetyResults.MCV

Lymphocyte tblBloodSafetyResults.Lymphocyte

Monocyte tblBloodSafetyResults.Moncyte

Eosinophil tblBloodSafetyResults.Eosinophil

Basophil tblBloodSafetyResults.Basophil

ESR tblBloodSafetyResults.ESR

Plasma Viscosity tblBloodSafetyResults.PlasmaViscosity

Urea tblBloodSafetyResults.Urea

Creatinine tblBloodSafetyResults.Creatinine

Sodium tblBloodSafetyResults.Sodium

Potassium tblBloodSafetyResults.Potassium

Bilirubin tblBloodSafetyResults.bilirubinSymbol tblBloodSafetyResults.bilirubin

Albumin tblBloodSafetyResults.Albumin

CRP tblBloodSafetyResults.CRPSymbol tblBloodSafetyResults.CRP

Comments tblBloodSafetyResults.Comments

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Subject details


DoB tblCandidates.DoB

Initials tblCandidates.Initials

Gender tblCandidates.Gender

Hospital No tblCandidates.HospitalNo

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Medical History


Condition/Operation tblMedicalSurgicalHistory.condition

Start Date: DD MMM YYYY tblMedicalSurgicalHistory.startDD

tblMedicalSurgicalHistory.startMM

tblMedicalSurgicalHistory.startYY

Stop Date: DD MMM YYYY tblMedicalSurgicalHistory.stopDD

tblMedicalSurgicalHistory.stopMM

tblMedicalSurgicalHistory.stopYY

Current related concomitant meds? tblMedicalSurgicalHistory.medication

Ongoing? (Trial end) tblMedicalSurgicalHistory.ongoing

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Visit Admin


Scheduled date tblVisitSchedule.ScheduledDate

Actual date tblVisitSchedule.ActualDate

If outside suggested dates, give reason tblVisitSchedule.ActualDateViolationReason

Visit result tblVisitSchedule.VisitResult

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Visit 1 Safety Bloods


Safety Bloods Taken tblVisit1.SafetyBloods

Date Taken tblVisit1.SafetyBloodsDate

Any LFT>x2 upper limit of normal tblVisit1.LFT

Haemoglobin<=10 tblVisit1.Haem

White cell count <3.5 tblVisit1.WBC

Neutrophils<1.5 tblVisit1.Neutro

Platelets <100x10/6/1 tblVisit1.Platelets

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Visit 2 consent and physical exam


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Has subject signed consent form? tblVisit2physicalexam.consentform

Consent form date? tblVisit2physicalexam.consentdate

Has subject agreed to provide a genetic sample? tblVisit2physicalexam.geneticconsent

Date of physical exam tblVisit2physicalexam.physicaldate

Units of alcohol per week tblVisit2physicalexam.alcoholunitsperweek

Weight (kg) tblVisit2physicalexam.weight

Height (cm) tblVisit2physicalexam.height

B.P. tblVisit2physicalexam.BPsystolic tblVisit2physicalexam.BPdiastolic

Heart rate tblVisit2physicalexam.pulse

Smoking status tblVisit2physicalexam.smokingstatus

If current, how many a day? tblVisit2physicalexam.smokingnumber

If former, when stopped MMM YYYY tblVisit2physicalexam.SmokingDateStoppedMMM

tblVisit2physicalexam.SmokingDateStoppedYYYY

General appearance tblVisit2physicalexam.PhysGen

Skin tblVisit2physicalexam.PhysSkin

Head/Neck/ENT tblVisit2physicalexam.PhysHead

Cardiovascular tblVisit2physicalexam.PhysCardio

CNS tblVisit2physicalexam.Physthyroid

Muskuloskeletal tblVisit2physicalexam.PhysMuscul

Respiratory tblVisit2physicalexam.PhysLung

GI tblVisit2physicalexam.PhysLymph

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Pregnancy Record

Screen1

Screen2


Subject’s current pregnancy status tblPregnancy.PregnancyStatus

Pregnancy notified at Visit no. tblPregnancy.PregNotificationVisit

EDD tblPregnancy.EDD

Pregnancy outcome tblPregnancy.Outcome

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Outcome date tblPregnancy.OutcomeDate

If delivered, select method tblPregnancy.DeliveryDetails

If aborted, select details tblPregnancy.AbortionDetails

Additional Pregnancies


Pregnancy status tblPregnancyAdditional.PregnancyStatus

EDD tblPregnancyAdditional.EDD

Pregnancy notified at Visit no: tblPregnancyAdditional.PregNotificationVisit

Pregnancy outcome tblPregnancyAdditional.Outcome

Outcome date tblPregnancyAdditional.OutcomeDate

If delivered, method: tblPregnancyAdditional.DeliveryDetails

If aborted, select details: tblPregnancyAdditional.AbortionDetails

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CDAI Diary


Day1 Stools tblCDAI.Stools1

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Day 2 Stools tblCDAI.Stools2






Day1 Abdominal pain tblCDAI.Pain1

Day 2 Abdominal pain tblCDAI.Pain2






Day1 General wellbeing tblCDAI.Wellbeing1

Day 2 General wellbeing tblCDAI.Wellbeing2






Are there any complications? tblCDAI.AnyComplications

Arthritis tblCDAI.CompArthritis

Iritis or uveitis tblCDAI.CompIritis

Erythema nodosum or pyoderma gangrenosum tblCDAI.CompErythema

Anal fissure, fistula or abcess tblCDAI.CompFissure

Fever >37.8 in the last week tblCDAI.CompFever

Any medications listed below used? tblCDAI.AnyMedications

Use of Loperamide tblCDAI.MedLoperamide

Use of Codeine tblCDAI.MedCodeine

Use of other antidiarrhoeals tblCDAI.MedAntiDia

Abdominal mass tblCDAI.AbdominalMass

Haematocrit level tblCDAI.Haematocrit

Bodyweight tblCDAI.BodyweightScore

CDAI total score tblCDAI.CDAITotal

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Adverse Events


Description tblAdverseEvents.AEDescription

Is this surgical intervention for Crohn’s? tblAdverseEvents.Surgery

Start date: (DD MMM YYYY) tblAdverseEvents.StartDD tblAdverseEvents.StartMMM tblAdverseEvents.StartYYYY

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Reported To (initials) tblAdverseEvents.ReportedTo

Severity tblAdverseEvents.Severity

Causality tblAdverseEvents.Causality

Action taken tblAdverseEvents.ActionTaken

Outcome tblAdverseEvents.Outcome

If led to SAE, describe tblAdverseEvents.LedtoSAE

Resolved date: (DD MMM YYYY) tblAdverseEvents.StopDD tblAdverseEvents.StopMMM tblAdverseEvents.StopYYYY

Ongoing (at trial end) tblAdverseEvents.Ongoing

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Physical Exam


Date of exam tblPhysicalExam.PhysicalDate

Weight tblPhysicalExam.Weight

B.P. (systolic/diastolic) tblPhysicalExam.BPsystolic tblPhysicalExam.BPdiastolic

Heart rate tblPhysicalExam.Pulse

General Appearance and Description tblPhysicalExam.PhysGen tblPhysicalExam.PhysGenAbn

Skin and Description tblPhysicalExam.PhysSkin tblPhysicalExam.PhysSkinAbn

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Head/Neck/ENT and Description tblPhysicalExam.PhysHead tblPhysicalExam.PhysHeadAbn

Cardiovascular and Description tblPhysicalExam.PhysCardio tblPhysicalExam.PhysCardioAbn

CNS and Description tblPhysicalExam.PhysThyroid tblPhysicalExam.PhysThyroidAbn

Musculoskeletal and Description tblPhysicalExam.PhysMuscul tblPhysicalExam.PhysMusculAbn

Respiratory and Description tblPhysicalExam.PhysLung tblPhysicalExam.PhysLungAbn

GI and Description tblPhysicalExam.PhysLymph tblPhysicalExam.PhysLymphAbn

Smoking status tblPhysicalExam.SmokingStatus

If current, how many a day? (Other) tblPhysicalExam.SmokingNumber tblPhysicalExam.SmokingNumberOther

If former, when stopped tblPhysicalExam.SmokingDateStoppedMMM tblPhysicalExam.SmokingDateStoppedYYYY

Alcohol units per week tblPhysicalExam.AlcoholUnits

Bloods Taken


Haematology tblBloodsTaken.Haematology

Biochemistry tblBloodsTaken.Biochemistry

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ESR tblBloodsTaken.ESR

Plasma Viscosity tblBloodsTaken.PlasmaViscosity

6-MP Metabolite level tblBloodsTaken.SixMP

Faecal calprotectin tblBloodsTaken.FaecalCalprotectin

Genetic studies tblBloodsTaken.Genetic

Serological studies tblBloodsTaken.Serological

Questionnaire

Tab1


Completed tblQuestionnaire.Completed

Date completed tblQuestionnaire.CompletedDate

Tab2

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Q1. tblQuestionnaire.IBDQ1








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Tab3

Annotations

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Screen Label Database field











Tab4

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Tab5

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Mobility tblQuestionnaire.HWBMobility

Self-care tblQuestionnaire.HWBSelfCare

Usual activities tblQuestionnaire.HWBActivities

Pain/discomfort tblQuestionnaire.HWBPain

Anxiety/Depression tblQuestionnaire.HWBAnxiety

B1. In general, health is: tblQuestionnaire.HWBB1

B2. Compared to one year ago, how would you rate your health tblQuestionnaire.HWBB2

B3a. Does your health now limit: vigorous activities tblQuestionnaire.HWBB3a

B3b. Does your health now limit: moderate activities tblQuestionnaire.HWBB3b

B3c. Does your health now limit: lifting or carrying tblQuestionnaire.HWBB3c

B3d. Does your health now limit: climbing several flights of stairs tblQuestionnaire.HWBB3d

B3e. Does your health now limit: climbing one flights of stairs tblQuestionnaire.HWBB3e

B3f. Does your health now limit: bending, kneeling or stooping tblQuestionnaire.HWBB3f

B3g. Does your health now limit: walking more than one mile tblQuestionnaire.HWBB3g

B3h. Does your health now limit: walking several hundred yards tblQuestionnaire.HWBB3h

B3i. Does your health now limit: walking one hundred yards tblQuestionnaire.HWBB3i

B3j. Does your health now limit: bathing and dressing yourself tblQuestionnaire.HWBB3j

B4a. How much of the time: cut down on time spent on work/other activities tblQuestionnaire.HWBB4a

B4b. How much of the time: accomplished less tblQuestionnaire.HWBB4b

B4c. How much of the time: limited on work/other activities tblQuestionnaire.HWBB4c

B4d. How much of the time: difficulty performing work/other activities tblQuestionnaire.HWBB4d

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Tab 6

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B5a. Cut down on amount of time spent on tblQuestionnaire.HWBB5a

B5b. Accomplished less tblQuestionnaire.HWBB5b

B5c. Did work or other activities less carefully tblQuestionnaire.HWBB5c

B6. Physical health or emotions interfered with social activities tblQuestionnaire.HWBB6

B7. How much bodily pain tblQuestionnaire.HWBB7

B8. Pain interfere with normal work tblQuestionnaire.HWBB8

B9a. Full of life tblQuestionnaire.HWBB9a

B9b. Nervous tblQuestionnaire.HWBB9b

B9c. Down in dumps tblQuestionnaire.HWBB9c

B9d. Calm and peaceful tblQuestionnaire.HWBB9d

B9e. Lot of energy tblQuestionnaire.HWBB9e

B9f. Downhearted and depressed tblQuestionnaire.HWBB9f

B9g. Worn out tblQuestionnaire.HWBB9g

B9h. Happy tblQuestionnaire.HWBB9h

B9i. Tired tblQuestionnaire.HWBB9i

B10. Physical health or emotions interfered with social activities tblQuestionnaire.HWBB10

B11a. Sick easier than other people tblQuestionnaire.HWBB11a

B11b. Healthy as anybody I know tblQuestionnaire.HWBB11b

B11c. Expect health to get worse tblQuestionnaire.HWBB11c

B11d. Health is excellent tblQuestionnaire.HWBB11d

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Tab 7


Comments tblQuestionnaire.Comments

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Change Status


Change to tblStatusChangeHistory.StatusChangedTo

Further details tblStatusChangeHistory.FurtherDetails

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Colonoscopy Findings


Rutgeerts score tblEndoscopyFindings.Rutgeerts

CDEIS tblEndoscopyFindings.CDEIS

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Dosage Reduction


Date of reduction tbldosagedecisions.FromDate

What should the dosage be reduced to? tbldosagedecisions.DrugRegimeID

Adverse Event tbldosagedecisions.AEID_Reduction

Blood Safety Message tbldosagedecisions.MessageID_Reduction

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Dosage Reduction Temporary


Date drug temporarily stopped tblTemporarydrugstop.FromDate

Reason for stop tblTemporarydrugstop.StopReason

Select message tblTemporarydrugstop.MessageID_Reduction

Select Adverse Event tblTemporarydrugstop.AEID_Reduction

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Drug Accountability


Dispensed Date tblDrugaccountability.DispensedDate

No of Tablets Dispensed tblDrugaccountability.TabletsDispensed

No of Tablets Expected to be Taken tblDrugaccountability.TabletsExpectedtobeTaken

No of Tablets Returned tblDrugaccountability.TabletsReturned

Discrepancy tblDrugaccountability.Discrepancy

Comments tblDrugaccountability.Comments

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Early withdrawal


Withdrawn participants have Status=2 (Early Withdrawal) tblStatusChangeHistory.StatusChangedTo

Withdrawal visit Date tblStatusChangeHistory.StatusChangeDate

Reason for withdawal tblStatusChangeHistory.FurtherDetails

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Medications 1


Have any new medications been initiated since the last visit? tblMedications.AnyMedications

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Medications 2


Medication tblMedications.Medication

Is this a prohibited medication? tblMedications.ProhibitedMedication

Is this rescue therapy for Crohn’s? tblMedications.RescueTherapyCrohns

Does this medication coupled with the IMP introduce a risk to the patient? tblMedications.RisktoPatient

Is it an Antacid? tblMedications.Antacid

Is it an Anti Diarrhoeal Agent? tblMedications.AntiDiarrhoeal

Is it a Spasmodic Agent? tblMedications.Spasmodic

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Treatment of AE? tblMedications.AE

Indication tblMedications.Purpose

Route tblMedications.Route

Dose tblMedications.Dose

Frequency tblMedications.Frequency

Start date tblMedications.StartDD tblMedications.StartMM tblMedications.StartYYYY

Stop date tblMedications.StopDD tblMedications.StopMM tblMedications.StopYYYY

Ongoing tblMedications.Ongoing

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Safety blood test results

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Actual Date tblBloodSafetyResults.ActualDate

Alk. Phos tblBloodSafetyResults.AlkPhos

ALT tblBloodSafetyResults.ALT

GGT tblBloodSafetyResults.GGTSymbol tblBloodSafetyResults.GGT

Haematocrit tblBloodSafetyResults.Haematocrit

Haemoglobin tblBloodSafetyResults.Haemoglobin

Neutrophils tblBloodSafetyResults.Neutrophils

Platelets tblBloodSafetyResults.Platelets

WBC tblBloodSafetyResults.WBC

Red Cell count tblBloodSafetyResults.RedCellCount

MCV tblBloodSafetyResults.MCV

Lymphocyte tblBloodSafetyResults.Lymphocyte

Monocyte tblBloodSafetyResults.Moncyte

Eosinophil tblBloodSafetyResults.Eosinophil

Basophil tblBloodSafetyResults.Basophil

ESR tblBloodSafetyResults.ESR

Plasma Viscosity tblBloodSafetyResults.PlasmaViscosity

Urea tblBloodSafetyResults.Urea

Creatinine tblBloodSafetyResults.Creatinine

Sodium tblBloodSafetyResults.Sodium

Potassium tblBloodSafetyResults.Potassium

Bilirubin tblBloodSafetyResults.bilirubinSymbol tblBloodSafetyResults.bilirubin

Albumin tblBloodSafetyResults.Albumin

CRP tblBloodSafetyResults.CRPSymbol tblBloodSafetyResults.CRP

Comments tblBloodSafetyResults.Comments

TOPPIC -Annotated CRF

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