9.1
Visit date
**NOTE: CHANGE "_v1" IN THE VARIABLE NAMES BASED ON VISIT NAME (in case of multiple visits) OR DELETE. REMOVE THIS EXPLANATION BEFORE GOING LIVE.**
9.3
Have there been any changes in the use of concomitant medication since the last study visit?
9.4
Click here to fill in the concomitant medication
Only shown if field 9.3 is equal to 1
9.5
Has the participant experienced one or more Adverse Event(s) since *< specify here the start date of registration of Adverse Events as recorded in the research protocol, e.g. the date of signed informed consent.>*
9.6
Click here to fill in the adverse event(s)
Only shown if field 9.5 is equal to 1
1.1
Description *(diagnosis (if known) or signs/symptoms)*
1.2
Start date
1.3
Ongoing at end of study
1.4
End date
Only shown if field 1.3 is equal to 2
**NOTE: End date adverse event is before start date adverse event. Please adjust!**
Only shown if field 1.30 is equal to 1
1.6
Intensity
1.7
Relation with study medication
1.8
Action study medication
1.9
Specify other study medication action
Only shown if field 1.8 is equal to 6
1.10
Other action *(check all that apply)*
1.11
Specify other other action
Only shown if field 1.10 is equal to 4
1.12
Is the Adverse Event reduced after discontinuation of the study medication or adjustment of the dose?
1.13
Is the study medication re-administered or is the adjusted dose returned to the original dosage?
Only shown if field 1.12 is equal to 1
1.14
Date of administration/dose return to original dosage
Only shown if field 1.13 is equal to 1
1.15
Did the Adverse Event recur after restarting the study medication or after the adjusted dose was returned to the original dosage?
Only shown if field 1.13 is equal to 1
1.16
Date Adverse Event recurred
Only shown if field 1.15 is equal to 1
1.17
Outcome
1.18
If stabilized, stabilization date
Only shown if field 1.17 is equal to 2
1.19
Specify residual symptoms
Only shown if field 1.17 is equal to 4
1.20
Date of death
Only shown if field 1.17 is equal to 5
1.21
Serious Adverse Event?
1.22
(check 1 or more answer options)
Only shown if field 1.21 is equal to 1
1.23
Admission date
Only shown if field 1.22 is equal to 3
1.24
Discharge date
Only shown if field 1.22 is equal to 3
**NOTE: Hospital discharge date is before hospital admission date. Please adjust!**
Only shown if field 1.31 is equal to 1
1.26
Specify other event
Only shown if field 1.22 is equal to 6
**Note: "Hospitalisation" is not checked for Other action AND for Specification SAE**
Only shown if field 1.32 is equal to 0
1.28
Expected?
**Potential SUSAR.** See "https://english.ccmo.nl/investigators/clinical-trials-with-medicinal-products-ctr/conduct-of-study-ctr/safety-reporting/serious-adverse-events-and-susars" for more information on reporting a SUSAR
Only shown if field 1.33 is equal to 1
1.30
Is stop datum vóór start datum adverse event?
1.31
Is ontslag datum vóór opname datum?
1.32
Cross check 'ziekenhuisopname' Overig vs SAE
1.33
SUSAR check
2.1
Description *(diagnosis (if known) or signs/symptoms)*
2.2
Start date
2.3
Ongoing at end of study
2.4
End date
Only shown if field 2.3 is equal to 2
**NOTE: End date adverse event is before start date adverse event. Please adjust!**
Only shown if field 2.28 is equal to 1
2.6
Intensity
2.7
Relation with study intervention
2.8
Action study treatment
2.9
Specify modified action
Only shown if field 2.8 is equal to 4
2.10
Other action *(check all that apply)*
2.11
Specify other other action
Only shown if field 2.10 is equal to 4
2.12
Is the Adverse Event reduced after discontinuation or modification of study treatment?
2.13
Is the study treatment resumed or is the adjusted study treatment returned to the original study treatment?
Only shown if field 2.12 is equal to 1
2.14
Date of resumption/reduction of study treatment
Only shown if field 2.13 is equal to 1
2.15
Did the Adverse Event recur after restarting study treatment or after the modified study treatment was returned to the original study treatment?
Only shown if field 2.13 is equal to 1
2.16
Date Adverse Event reccurred
Only shown if field 2.15 is equal to 1
2.17
Outcome
2.18
If stabilized, date of stabilization
Only shown if field 2.17 is equal to 2
2.19
Specify residual symptoms
Only shown if field 2.17 is equal to 4
2.20
Date of death
Only shown if field 2.17 is equal to 5
2.21
Serious Adverse Event?
2.22
(check 1 or more answer options)
Only shown if field 2.21 is equal to 1
2.23
Admission date
Only shown if field 2.22 is equal to 3
2.24
Discharge date
Only shown if field 2.22 is equal to 3
NOTE: Discharge date of hospitalisation is before admission date of hospitalisation. Please adjust!
Only shown if field 2.29 is equal to 1
2.26
Specify other event
Only shown if field 2.22 is equal to 6
NOTE: "Hospitalisation"; is not checked for Other action AND for Specification SAE
Only shown if field 2.30 is equal to 0
2.28
Is stop datum vóór start datum?
2.29
Is opname datum vóór ontslag datum?
2.30
Cross check 'ziekenhuisopname' Overig vs SAE
3.1
Description *(diagnosis (if known) or signs/symptoms)*
3.2
Start date
3.3
Ongoing at end of study
3.4
End date
Only shown if field 3.3 is equal to 2
**NOTE: End date adverse event is before start date adverse event. Please adjust!**
Only shown if field 3.30 is equal to 1
3.6
Intensity
3.7
Relation with study medication
3.8
Action medical device
3.9
Specify other action medical device
Only shown if field 3.8 is equal to 6
3.10
Other action *(check all that apply)*
3.11
Specify other other action
Only shown if field 3.10 is equal to 4
3.12
Is the Adverse Event reduced after discontinuation of the study medication or adjustment of the dose?
3.13
Is the study medication re-administered or is the adjusted dose returned to the original dosage?
Only shown if field 3.12 is equal to 1
3.14
Date of administration/dose returned to original dosage
Only shown if field 3.13 is equal to 1
3.15
Did the Adverse Event recur after restarting the medical device or after the adjusted dose was returned to the original dosage?
Only shown if field 3.13 is equal to 1
3.16
Date Adverse Event recurred
Only shown if field 3.15 is equal to 1
3.17
Outcome
3.18
If stabilized, stabilization date
Only shown if field 3.17 is equal to 2
3.19
Specify residual symptoms
Only shown if field 3.17 is equal to 4
3.20
Date of death
Only shown if field 3.17 is equal to 5
3.21
Serious Adverse Event?
3.22
(check 1 or more answer options)
Only shown if field 3.21 is equal to 1
3.23
Admission date
Only shown if field 3.22 is equal to 3
3.24
Discharge date
Only shown if field 3.22 is equal to 3
NOTE: Discharge date of hospitalisation is before admission date of hospitalisation. Please adjust!
Only shown if field 3.31 is equal to 1
3.26
Specify other event
Only shown if field 3.22 is equal to 6
**NOTE: "Hospitalisation" is not checked for Other action AND for Specification SAE**
Only shown if field 3.32 is equal to 0
3.28
Expected?
**Potential USADE.** See "https://www.ccmo.nl/onderzoekers/publicaties/publicaties/2021/05/08/flowchart-ongewenste-voorvallen-onderzoek-met-medische-hulpmiddelen" for more information on reporting a USADE
Only shown if field 3.33 is equal to 1
3.30
Is stop datum vóór start datum adverse event?
3.31
Is ontslag datum vóór opname datum?
3.32
Cross check 'ziekenhuisopname' Overig vs SAE
3.33
USADE check
1.1
Medication name *(brand/generic name)*
1.2
Indication
1.3
Dose per administration
1.4
Unit
1.5
Specify other unit:
Only shown if field 1.4 is equal to 33
1.6
Frequency
1.7
Specify other frequency:
Only shown if field 1.6 is equal to 16
1.8
Route
1.9
Specify other route:
Only shown if field 1.8 is equal to 26
1.10
Was the participant already receiving this concomitant medication prior to the study?
1.11
Start date
Only shown if field 1.10 is equal to 2
1.12
Ongoing at the end of study
1.13
End date
Only shown if field 1.12 is equal to 2
1.14
Is eind datum vóór start datum medicatie?
**NOTE: End date of medication is before the start date of medication. Please adjust!**
Only shown if field 1.14 is equal to 1
YesNo
Med_unit
Med_freq
Med_route
Intensity AE
Relation AE
Action AE
Other action AE
YesNoNa
YesNoUnk
Outome AE
Spec SAE
Action - ND