1.1
Visit date
1.2
Has the participant signed the Informed Consent Form?
1.3
Date of signing the Informed Consent Form
Only shown if field 1.2 is equal to 1
1.4
Version number signed Informed Consent
Only shown if field 1.2 is equal to 1
1.5
Has the participant given permission for future reuse of data?
Only shown if field 1.2 is equal to 1
1.6
Has the participant given permission for the storage of body material for the specified retention period?
Only shown if field 1.2 is equal to 1
2.1
Visit date
**Informed consent with children and youngsters (minors)**
2.3
To which age category does the minor participant belong?
___*Participant aged <12 years:*___
Only shown if field 2.3 is equal to 1
2.5
Written consent parent 1 / guardian
Only shown if field 2.3 is equal to 1
2.6
Date consent parent 1 / guardian:
Only shown if field 2.5 is equal to 1
2.7
Written consent parent 2 / guardian
Only shown if field 2.3 is equal to 1
2.8
Date consent parent 2 / guardian:
Only shown if field 2.7 is equal to 1
2.9
Will/did the participant turn 12 during the course of the study?
Only shown if field 2.3 is equal to 1
___*Participant aged 12-16 years:*___
Only shown if field 2.3 is equal to 2
2.11
Written consent parent 1 / guardian
Only shown if field 2.3 is equal to 2
2.12
Date consent parent 1 / guardian:
Only shown if field 2.11 is equal to 1
2.13
Written consent parent 2 / guardian
Only shown if field 2.3 is equal to 2
2.14
Date consent parent 2 / guardian:
Only shown if field 2.13 is equal to 1
2.15
Written consent child
Only shown if field 2.3 is equal to 2
2.16
Date consent child:
Only shown if field 2.13 is equal to 1
___*Participant aged >16 years:*___
Only shown if field 2.3 is equal to 3
2.18
Written consent child
Only shown if field 2.3 is equal to 3
2.19
Date consent child:
Only shown if field 2.18 is equal to 1
**Deferred informed consent**
3.2
Date first study procedure/randomization
3.3
Time first study procedure/randomization
3.4
Randomization performed by:
3.5
Signed informed consent
3.6
Date of written consent:
Only shown if field 3.5 is equal to 1
3.7
Time of written consent:
Only shown if field 3.5 is equal to 1
3.8
Consent provided by
Only shown if field 3.5 is equal to 1
3.9
Within time window?
Only shown if field 3.5 is equal to 1
3.10
Protocol deviation
Only shown if field 3.9 is equal to 2
3.11
Consent in second instance?
Only shown if field 3.5 is equal to 1
3.12
Date of consent in second instance:
Only shown if field 3.11 is equal to 1
3.13
Time of consent in second instance:
Only shown if field 3.11 is equal to 1
3.14
Date of death:
Only shown if field 3.11 is equal to 2
3.15
Time of death:
Only shown if field 3.11 is equal to 2
___**Remove all data from eCRF except eligibility and randomization pages.**___
Only shown if field 3.11 is equal to 4
3.17
Date of written consent:
Only shown if field 3.5 is equal to 2
3.18
Time of written consent:
Only shown if field 3.5 is equal to 2
3.19
Within time window?
Only shown if field 3.5 is equal to 2
3.20
Protocol deviation
Only shown if field 3.19 is equal to 2
3.21
Date of death:
Only shown if field 3.5 is equal to 3
3.22
Time of death:
Only shown if field 3.5 is equal to 3
3.23
Within time window?
Only shown if field 3.5 is equal to 3
3.24
Infaust prognosis within time window?
Only shown if field 3.23 is equal to 2
3.25
Date infaust prognosis
Only shown if field 3.24 is equal to 1
3.26
Protocol deviation
Only shown if field 3.24 is equal to 2
___**Remove all data from eCRF except eligibility and randomization pages.**___
Only shown if field 3.5 is equal to 4
*___INCLUSION CRITERIA___*
4.2
< Inclusion criterion 1> *(instruction: copy from the protocol)*
4.3
< Inclusion criterion 2>
4.4
< Inclusion criterion 3>
4.5
< Inclusion criterion 4>
4.6
< Inclusion criterion 5>
4.7
< Inclusion criterion 6>
4.8
< Inclusion criterion 7>
4.9
< Inclusion criterion 8>
4.10
< Inclusion criterion 9>
4.11
< Inclusion criterion 10>
4.12
< Inclusion criterion 11>
4.13
< Inclusion criterion 12>
4.14
Are all inclusion criteria answered with 'YES'?
*___EXCLUSION CRITERIA___*
4.16
< Exclusion criterion 1> *(instruction: copy from the protocol)*
4.17
< Exclusion criterion 2>
4.18
< Exclusion criterion 3>
4.19
< Exclusion criterion 4>
4.20
< Exclusion criterion 5>
4.21
< Exclusion criterion 6>
4.22
< Exclusion criterion 7>
4.23
< Exclusion criterion 8>
4.24
< Exclusion criterion 9>
4.25
< Exclusion criterion 10>
4.26
< Exclusion criterion 11>
4.27
< Exclusion criterion 12>
4.28
Are all exclusion criteria answered with 'NO'?
The participant can be included in the study if the Informed Consent Form is signed, all inclusion criteria are answered with “YES” and all exclusion criteria are answered with “NO”.
5.2
Can this participant be included in the study?
5.3
Will this participant be included in the study?
5.4
Reason participant not included in study:
Only shown if field 5.3 is equal to 2
5.5
Controle 5.2 tov 5.1
***ANSWER 5.2 IS NOT EQUAL TO 5.1! Please verify!***
Only shown if field 5.5 is equal to 2
5.7
Please repeat answer 5.2 here
6.1
Year of birth (YYYY)
NOTE: Year of birth is in the future. Please change
Only shown if field 6.16 is equal to 0
6.3
Age at inclusion
6.4
Age at inclusion (weeks) *(to be used in neonatology)*
6.5
Age at inclusion (days) *(to be used in neonatology)*
6.6
Gender
6.7
Specify other gender:
Only shown if field 6.6 is equal to 3
6.8
Ethnicity *(only if mentioned in the PIF/ICF)*
6.9
Specify other ethnicity:
Only shown if field 6.8 is equal to 8
6.10
Body weight (kg)
6.11
Body length (cm)
6.12
BMI (kg/m^2)
6.13
Highest level of education *(only if mentioned in the PIF/ICF)*
6.14
Specify other education:
Only shown if field 6.13 is equal to 9
6.15
Other
6.16
Check birthyear
**Current intoxications**
7.2
Smoking
7.3
Year start smoking
Only shown if field 7.2 is not 3
NOTE: Start year smoking is in the future. Please change
Only shown if field 7.18 is equal to 0
7.5
Year stop smoking
Only shown if field 7.2 is equal to 2
NOTE: Stop year smoking is in the future. Please change
Only shown if field 7.19 is equal to 0
7.7
Number of units per day
Only shown if field 7.2 is not 3
7.8
Number of packyears
Only shown if field 7.2 is not 3
7.9
Alcohol
7.10
Number of units
Only shown if field 7.9 is not 3
7.11
Units per day/week
Only shown if field 7.9 is not 3
7.12
Drugs
7.13
Year start drug use
Only shown if field 7.2 is not 3
NOTE: Start year of drug use is in the future. Please change
Only shown if field 7.20 is equal to 0
7.15
Year stop drug use
Only shown if field 7.2 is equal to 2
NOTE: Stop year of drug use is in the future. Please change
Only shown if field 7.21 is equal to 0
7.17
Specify which drugs and which route:
Only shown if field 7.12 is not 3
7.18
Check start smoking
7.19
Check stop smoking
7.20
Check start drugs
7.21
Check stop drugs
**(Relevant) medical history including surgical history**
8.2
Cardiovascular
8.3
Diagnosis / intervention cardiovascular
Only shown if field 8.2 is equal to 1
8.4
Date of diagnosis / intervention cardiovascular
Only shown if field 8.2 is equal to 1
8.5
Diagnosis / intervention cardiovascular still present?
Only shown if field 8.2 is equal to 1
8.6
Respiratory
8.7
Diagnosis / intervention respiratory
Only shown if field 8.6 is equal to 1
8.8
Date of diagnosis / intervention respiratory
Only shown if field 8.6 is equal to 1
8.9
Diagnosis / intervention respiratory still present?
Only shown if field 8.6 is equal to 1
8.10
Liver and bile ducts
8.11
Diagnosis / intervention liver and bile ducts
Only shown if field 8.10 is equal to 1
8.12
Date of diagnosis / intervention liver and bile ducts
Only shown if field 8.10 is equal to 1
8.13
Diagnosis / intervention liver and bile ducts still present?
Only shown if field 8.10 is equal to 1
8.14
Gastrointestinal
8.15
Diagnosis / intervention gastrointestinal
Only shown if field 8.14 is equal to 1
8.16
Date of diagnosis / intervention gastrointestinal
Only shown if field 8.14 is equal to 1
8.17
Diagnosis / intervention gastrointestinal still present?
Only shown if field 8.14 is equal to 1
8.18
Genito-urinary
8.19
Diagnosis / intervention genito-urinary
Only shown if field 8.18 is equal to 1
8.20
Date of diagnosis / intervention genito-urinary
Only shown if field 8.18 is equal to 1
8.21
Diagnosis / intervention genito-urinary still present?
Only shown if field 8.18 is equal to 1
8.22
Endocrine
8.23
Diagnosis / intervention endocrine
Only shown if field 8.22 is equal to 1
8.24
Date of diagnosis / intervention endocrine
Only shown if field 8.22 is equal to 1
8.25
Diagnosis / intervention endocrine still present?
Only shown if field 8.22 is equal to 1
8.26
Hematological
8.27
Diagnosis / intervention hematological
Only shown if field 8.26 is equal to 1
8.28
Date of diagnosis / intervention hematological
Only shown if field 8.26 is equal to 1
8.29
Diagnosis / intervention hematological still present?
Only shown if field 8.26 is equal to 1
8.30
Musculoskeletal
8.31
Diagnosis / intervention musculoskeletal
Only shown if field 8.30 is equal to 1
8.32
Date of diagnosis / intervention musculoskeletal
Only shown if field 8.30 is equal to 1
8.33
Diagnosis / intervention musculoskeletal still present?
Only shown if field 8.30 is equal to 1
8.34
Neoplasia
8.35
Diagnosis / intervention neoplasia
Only shown if field 8.34 is equal to 1
8.36
Date of diagnosis / intervention neoplasia
Only shown if field 8.34 is equal to 1
8.37
Diagnosis / intervention neoplasia still present?
Only shown if field 8.34 is equal to 1
8.38
Neurological
8.39
Diagnosis / intervention neurological
Only shown if field 8.38 is equal to 1
8.40
Date of diagnosis / intervention neurological
Only shown if field 8.38 is equal to 1
8.41
Diagnosis / intervention neurological still present?
Only shown if field 8.38 is equal to 1
8.42
Psychological
8.43
Diagnosis / intervention psychological
Only shown if field 8.42 is equal to 1
8.44
Date of diagnosis / intervention psychological
Only shown if field 8.42 is equal to 1
8.45
Diagnosis / intervention psychological still present?
Only shown if field 8.42 is equal to 1
8.46
Immunological
8.47
Diagnosis / intervention immunological
Only shown if field 8.46 is equal to 1
8.48
Date of diagnosis / intervention immunological
Only shown if field 8.46 is equal to 1
8.49
Diagnosis / intervention immunological still present?
Only shown if field 8.46 is equal to 1
8.50
Dermatological
8.51
Diagnosis / intervention dermatological
Only shown if field 8.50 is equal to 1
8.52
Date of diagnosis / intervention dermatological
Only shown if field 8.50 is equal to 1
8.53
Diagnosis / intervention dermatological still present?
Only shown if field 8.50 is equal to 1
8.54
Allergy
8.55
Diagnosis / intervention allergy
Only shown if field 8.54 is equal to 1
8.56
Date of diagnosis / intervention allergy
Only shown if field 8.54 is equal to 1
8.57
Diagnosis / intervention allergy still present?
Only shown if field 8.54 is equal to 1
8.58
Head, eyes, ears, nose and mouth
8.59
Diagnosis / intervention head, eyes, ears, nose and mouth
Only shown if field 8.58 is equal to 1
8.60
Date of diagnosis / intervention head, eyes, ears, nose and mouth
Only shown if field 8.58 is equal to 1
8.61
Diagnosis / intervention head, eyes, ears, nose and mouth still present?
Only shown if field 8.58 is equal to 1
8.62
Other
8.63
Diagnosis / intervention other
Only shown if field 8.62 is equal to 1
8.64
Date of diagnosis / intervention other
Only shown if field 8.62 is equal to 1
8.65
Diagnosis / intervention other still present?
Only shown if field 8.62 is equal to 1
8.66
Comorbidities
8.67
Allergies
8.68
Specify which allergies:
Only shown if field 8.67 is equal to 1
8.69
Exercise/sports
8.70
Specify which exercise/sports:
Only shown if field 8.69 is equal to 1
8.71
Family medical history *(only use if relevant to your research question and analysis and stated in PIF and Protocol)* *(check all that aply)*
8.72
Specify family medical history of heart disease
Only shown if field 8.71 is equal to 1
8.73
Specify family medical history cancer
Only shown if field 8.71 is equal to 2
8.74
Specify family medical history genetic disorders
Only shown if field 8.71 is equal to 3
8.75
Specify other family medical history
Only shown if field 8.71 is equal to 4
8.76
Current medication
8.77
Previous treatment(s)
8.78
Vaccinations *(only use if relevant to your research question and analysis)*
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
10.1
Visit date
**NOTE: CHANGE "_v2" IN THE VARIABLE NAMES BASED ON VISIT NAME (in case of multiple visits) OR DELETE. REMOVE THIS EXPLANATION BEFORE GOING LIVE.**
10.3
Have there been any changes in the use of concomitant medication since the last study visit?
10.4
Click here to fill in the concomitant medication
Only shown if field 10.3 is equal to 1
10.5
Has the participant experienced one or more Adverse Event(s) between this visit and the previous visit?
10.6
Click here to fill in the adverse event(s)
Only shown if field 10.5 is equal to 1
11.1
Visit date
11.2
Biobank samples collected?
11.3
Biobank samples collected according to protocol?
Only shown if field 11.2 is equal to 1
11.4
Date biobank samples taken
Only shown if field 11.2 is equal to 1
11.5
Were the samples sent?
Only shown if field 11.2 is equal to 1
11.6
Date samples sent:
Only shown if field 11.5 is equal to 1
11.7
Reason samples were not sent:
Only shown if field 11.5 is equal to 2
11.8
Protocol deviation - samples not sent
Only shown if field 11.5 is equal to 2
11.9
Protocol deviation - samples not collected
Only shown if field 11.2 is equal to 2
11.10
Imaging performed?
11.11
What type of imaging was performed?
Only shown if field 11.10 is equal to 1
11.12
Specify type of X-ray
Only shown if field 11.11 is equal to 1
11.13
Date imaging performed
Only shown if field 11.10 is equal to 1
11.14
Result imaging
Only shown if field 11.10 is equal to 1
11.15
Protocol deviation - imaging not performed
Only shown if field 11.10 is equal to 2
11.16
Vital signs measured?
11.17
Date vital signs measured
Only shown if field 11.16 is equal to 1
11.18
What vital signs were measured? *(check all that apply)*
Only shown if field 11.16 is equal to 1
11.19
Systolic blood pressure (mmHg):
Only shown if field 11.18 is equal to 1
11.20
Diastolic blood pressure (mmHg):
Only shown if field 11.18 is equal to 1
11.21
Body temperature (°C):
Only shown if field 11.18 is equal to 2
11.22
Respiratory rate (/min):
Only shown if field 11.18 is equal to 3
11.23
Heart rate (bpm):
Only shown if field 11.18 is equal to 4
11.24
Weight (kg):
Only shown if field 11.18 is equal to 5
11.25
Protocol deviation - vital signs not measured
Only shown if field 11.16 is equal to 2
11.26
Physical examination
11.27
Date physical examination
Only shown if field 11.26 is equal to 1
11.28
Clinically significant finding
Only shown if field 11.26 is equal to 1
11.29
Which finding is clinically significant? *(check all that apply)*
Only shown if field 11.28 is equal to 1
11.30
Specify finding general impression:
Only shown if field 11.29 is equal to 1
11.31
Specify finding head/neck/throat:
Only shown if field 11.29 is equal to 2
11.32
Specify finding heart:
Only shown if field 11.29 is equal to 3
11.33
Specify finding lungs:
Only shown if field 11.29 is equal to 4
11.34
Specify finding abdomen:
Only shown if field 11.29 is equal to 5
11.35
Specify finding extremities:
Only shown if field 11.29 is equal to 6
11.36
Specify finding other:
Only shown if field 11.29 is equal to 7
11.37
Protocol deviation - physical examination not measured
Only shown if field 11.26 is equal to 2
11.38
Other measurements
11.39
Define other measurements:
Only shown if field 11.38 is equal to 1
11.40
Date other measurements
Only shown if field 11.38 is equal to 1
11.41
Result other measurements
Only shown if field 11.38 is equal to 1
11.42
Protocol deviation - other measurements not measured
Only shown if field 11.38 is equal to 2
12.1
Date end of study
12.2
Indicate whether the participant completed the full study as specified in the protocol or terminated the study early:
12.3
If terminated early, please indicate which reason is **most applicable**:
Only shown if field 12.2 is equal to 2
12.4
Specify Adverse Event (AE):
Only shown if field 12.3 is equal to 2
12.5
Date of death
Only shown if field 12.3 is equal to 3
12.6
Primary cause of death
Only shown if field 12.3 is equal to 3
12.7
Date of last contact with this participant in this study:
Only shown if field 12.3 is equal to 4
12.8
Date consent withdrawn
Only shown if field 12.3 is equal to 5
12.9
Reason consent withdrawn
Only shown if field 12.3 is equal to 5
12.10
Date of decision:
Only shown if field 12.3 is equal to 6
12.11
Reason of decision
Only shown if field 12.3 is equal to 6
12.12
Other reason
Only shown if field 12.3 is equal to 8
13.1
I declare that all entries in the electronic case report forms (CRFs), including corrections, were made by a trial staff member identified on the ‘sites signature and delegation Log‘ and that the collected data in the electronic case report forms corresponds to a truthful, careful and complete transcription of the source data, which were generated during the study.
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
1.1
Medication name
1.2
Frequency
1.3
Specify other frequency:
Only shown if field 1.2 is equal to 16
1.4
Dosage *(for example 80 mg)*
1.5
Unit
1.6
Specify other unit:
Only shown if field 1.5 is equal to 33
1.1
Date
1.2
Treatment received
1.1
Deviation has impact on:
1.2
Date deviation occurred
1.3
At what level did the deviation occur? *(check all that apply)*
1.4
Date of awareness
**Reported by:**
1.6
- Name
1.7
- Role
1.8
Type of deviation
1.9
Specify other type of deviation
Only shown if field 1.8 is equal to 10
1.10
Description of the deviation
1.11
Reason for the deviation (root cause analysis)
1.12
Corrective action(s) taken to resolve this occurrence?
1.13
Preventive action(s) taken to prevent future occurrence?
1.14
Calculation action specify
1.15
If yes, what type of action(s)? *(check all that apply)* ***You may add more details of action(s) taken in section ‘Comments’ below.***
Only shown if field 1.14 is equal to 1
1.16
Specify last visit to be performed:
Only shown if field 1.15 is equal to 2
1.17
Specify other action
Only shown if field 1.15 is equal to 11
1.18
In case of a medicinal study under CTR, is this deviation a serious breach?(3)
1.19
Corrective & preventative action (CAPA)
1.20
Comments
2.1
Deviation has impact on:
2.2
Name local principal investigator (PI)
2.3
Date deviation occurred
2.4
At what level did the deviation occur? *(check all that apply)*
2.5
Date awareness
**Reported by:**
2.7
- Name
2.8
- Role
2.9
Type of deviation
2.10
Specify other type of deviation
Only shown if field 2.9 is equal to 10
2.11
Description of the deviation
2.12
Reason for the deviation (root cause analysis)
2.13
Corrective action(s) taken to resolve this occurrence?
2.14
Preventive action(s) taken to prevent future occurrence?
2.15
Calculation action specify
2.16
Corrective & preventative action (CAPA)
Only shown if field 2.15 is equal to 1
The following questions should be completed by the coordinating principal investigator*. _(*the coordinating principal investigator has the final responsibility for the study as a whole, it is important to have his/her assessment of the impact of the deviation.)_
3.2
Does this deviation affect the participant’s safety, rights or well-being?
3.3
Explain your choice:
3.4
Does this deviation affect the reliability and robustness of the study data?
3.5
Explain your choice:
3.6
Corrective action(s) taken to resolve this occurrence?
3.7
Preventive action(s) taken to prevent future occurrence?
3.8
Calculation action specify
3.9
If yes, what type of action(s)? *(check all that apply)* ***You may add more details of action(s) taken in section ‘Comments’ below.***
3.10
Specify last visit to be performed:
Only shown if field 3.9 is equal to 2
3.11
Specify other action:
Only shown if field 3.9 is equal to 11
3.12
In case of a medicinal study under CTR, is this deviation a serious breach?(3)
3.13
Comments
1.1
Vaccination *(name of vaccine against)*
1.2
Vaccination date
YesNo
IC_category
YesNo consent-Parent/Guard
YesNo consent 12yr
YesNo consent-child
Deferred cons
Consent child
Deviation_impact
Deviation level(AUMC)
Deviation_type
Action type deviation
Serious deviation
Deviation level(local)
DeferConsent
YesNoNa
No inclusion
Gender
Etnicity
Education
Smoking/Alco/Drugs
Alco unit
family medical history
Med_freq
Med_unit
Med_route
Intensity AE
Relation AE
Action AE
Other action AE
YesNoUnk
Outome AE
Spec SAE
Action - ND
monsters not used
type prot deviation
Type of imaging
Vital signs
type lichamelijk onderzoek
EOS_complete
EOS_reason