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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
2
Visit-1 Inclusion/Exclusion
Annotations Screen Label Database field
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
3
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
4
Annotations Screen Label Database field
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
5
Pre-randomisation blood test results
6
7
Annotations Screen Label Database field
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
8
Subject details
Annotations Screen Label Database field
DoB tblCandidates.DoB
Initials tblCandidates.Initials
Gender tblCandidates.Gender
Hospital No tblCandidates.HospitalNo
9
Medical History
Annotations Screen Label Database field
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
10
Visit Admin
Annotations Screen Label Database field
Scheduled date tblVisitSchedule.ScheduledDate
Actual date tblVisitSchedule.ActualDate
If outside suggested dates, give reason tblVisitSchedule.ActualDateViolationReason
Visit result tblVisitSchedule.VisitResult
11
Visit 1 Safety Bloods
Annotations Screen Label Database field
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
12
Visit 2 consent and physical exam
Annotations Screen Label Database field
13
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
14
Pregnancy Record
Screen1
Screen2
Annotations Screen Label Database field
Subject’s current pregnancy status tblPregnancy.PregnancyStatus
Pregnancy notified at Visit no. tblPregnancy.PregNotificationVisit
EDD tblPregnancy.EDD
Pregnancy outcome tblPregnancy.Outcome
15
Outcome date tblPregnancy.OutcomeDate
If delivered, select method tblPregnancy.DeliveryDetails
If aborted, select details tblPregnancy.AbortionDetails
Additional Pregnancies
Annotations Screen Label Database field
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
16
CDAI Diary
Annotations Screen Label Database field
Day1 Stools tblCDAI.Stools1
17
Day 2 Stools tblCDAI.Stools2
Day 3 Stools tblCDAI.Stools3
Day 4 Stools tblCDAI.Stools4
Day 5 Stools tblCDAI.Stools5
Day 6 Stools tblCDAI.Stools6
Day 7 Stools tblCDAI.Stools7
Day1 Abdominal pain tblCDAI.Pain1
Day 2 Abdominal pain tblCDAI.Pain2
Day 3 Abdominal pain tblCDAI.Pain3
Day 4 Abdominal pain tblCDAI.Pain4
Day 5 Abdominal pain tblCDAI.Pain5
Day 6 Abdominal pain tblCDAI.Pain6
Day 7 Abdominal pain tblCDAI.Pain7
Day1 General wellbeing tblCDAI.Wellbeing1
Day 2 General wellbeing tblCDAI.Wellbeing2
Day 3 General wellbeing tblCDAI.Wellbeing3
Day 4 General wellbeing tblCDAI.Wellbeing4
Day 5 General wellbeing tblCDAI.Wellbeing5
Day 6 General wellbeing tblCDAI.Wellbeing6
Day 7 General wellbeing tblCDAI.Wellbeing7
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
Annotations Screen Label Database field
Description tblAdverseEvents.AEDescription
Is this surgical intervention for Crohn’s? tblAdverseEvents.Surgery
Start date: (DD MMM YYYY) tblAdverseEvents.StartDD tblAdverseEvents.StartMMM tblAdverseEvents.StartYYYY
19
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
20
Physical Exam
Annotations Screen Label Database field
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
Annotations Screen Label Database field
Haematology tblBloodsTaken.Haematology
Biochemistry tblBloodsTaken.Biochemistry
22
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
Annotations Screen Label Database field
Completed tblQuestionnaire.Completed
Date completed tblQuestionnaire.CompletedDate
Tab2
23
Annotations Screen Label Database field
Q1. tblQuestionnaire.IBDQ1
Q2. tblQuestionnaire.IBDQ2
Q3. tblQuestionnaire.IBDQ3
Q4. tblQuestionnaire.IBDQ4
Q5. tblQuestionnaire.IBDQ5
Q6. tblQuestionnaire.IBDQ6
Q7. tblQuestionnaire.IBDQ7
Q8. tblQuestionnaire.IBDQ8
24
Q9. tblQuestionnaire.IBDQ9
Q10. tblQuestionnaire.IBDQ10
Tab3
Annotations
25
Screen Label Database field
Q11. tblQuestionnaire.IBDQ11
Q12. tblQuestionnaire.IBDQ12
Q13. tblQuestionnaire.IBDQ13
Q14. tblQuestionnaire.IBDQ14
Q15. tblQuestionnaire.IBDQ15
Q16. tblQuestionnaire.IBDQ16
Q17. tblQuestionnaire.IBDQ17
Q18. tblQuestionnaire.IBDQ18
Q19. tblQuestionnaire.IBDQ19
Q20. tblQuestionnaire.IBDQ20
Tab4
26
Annotations Screen Label Database field
Q21. tblQuestionnaire.IBDQ21
Q22. tblQuestionnaire.IBDQ22
Q23. tblQuestionnaire.IBDQ23
27
Q24. tblQuestionnaire.IBDQ24
Q25. tblQuestionnaire.IBDQ25
Q26. tblQuestionnaire.IBDQ26
Q27. tblQuestionnaire.IBDQ27
Q28. tblQuestionnaire.IBDQ28
Q29. tblQuestionnaire.IBDQ29
Q30. tblQuestionnaire.IBDQ30
Q31. tblQuestionnaire.IBDQ31
Q32. tblQuestionnaire.IBDQ32
Tab5
28
29
Annotations Screen Label Database field
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
30
Tab 6
31
Annotations Screen Label Database field
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
32
Tab 7
Annotations Screen Label Database field
Comments tblQuestionnaire.Comments
33
Change Status
Annotations Screen Label Database field
Change to tblStatusChangeHistory.StatusChangedTo
Further details tblStatusChangeHistory.FurtherDetails
34
Colonoscopy Findings
Annotations Screen Label Database field
Rutgeerts score tblEndoscopyFindings.Rutgeerts
CDEIS tblEndoscopyFindings.CDEIS
35
Dosage Reduction
Annotations Screen Label Database field
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
36
Dosage Reduction Temporary
Annotations Screen Label Database field
Date drug temporarily stopped tblTemporarydrugstop.FromDate
Reason for stop tblTemporarydrugstop.StopReason
Select message tblTemporarydrugstop.MessageID_Reduction
Select Adverse Event tblTemporarydrugstop.AEID_Reduction
37
Drug Accountability
Annotations Screen Label Database field
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
38
Early withdrawal
Annotations Screen Label Database field
Withdrawn participants have Status=2 (Early Withdrawal) tblStatusChangeHistory.StatusChangedTo
Withdrawal visit Date tblStatusChangeHistory.StatusChangeDate
Reason for withdawal tblStatusChangeHistory.FurtherDetails
39
Medications 1
Annotations Screen Label Database field
Have any new medications been initiated since the last visit? tblMedications.AnyMedications
40
Medications 2
Annotations Screen Label Database field
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
41
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
42
Safety blood test results
43
44
Annotations Screen Label Database field
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