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)*
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
1: Yes
2: No
IC_category
1: < 12 years
2: 12-16 years
3: > 16 years
YesNo consent-Parent/Guard
1: Yes
2: No – no second parent/legal guardian
3: No – participant cannot be enrolled
YesNo consent 12yr
1: Yes – participant must sign ICF at the age of 12 years old
2: No – no further action required
YesNo consent-child
1: Yes
2: No – participant incapacitated
3: No – participant cannot be enrolled
Deferred cons
1: Consent from participant representative
2: Consent from participant
3: Participant deceased before consent was obtained
4: No consent given
Consent child
1: Mentor/curator (appointed by court)
2: Authorized representative
3: Spouse (husband/wife/legal partner)
4: Life partner
5: Parents
6: Adult children
7: Brother/sister
8: No representative available
Deviation_impact
1: Participant’s rights, safety or well‐being
2: Reliability and robustness of the study data
Deviation level(AUMC)
1: Study
2: Participant
3: Site
Deviation_type
1: Informed consent process
2: Eligibility criteria
3: Investigational product / intervention
4: Equipment and facilities
5: Prohibited concomitant medication/treatment
6: Withdrawal criteria/ discontinuation
7: Safety reporting
8: Other study protocol procedures
9: Privacy
10: Other
Action type deviation
1: Participant(s) may continue in the study
2: Participant(s) must be withdrawn from the study *(specify last visit to be performed below)*
3: Site staff will be retrained on IC-process
4: Site staff will be retrained on randomisation procedure
5: Site staff will be retrained on safety reporting
6: Site staff will be retrained on protocol
7: Protocol will be amended(1)
8: Enrollment on site level will be put on temporary halt(2)
9: Study enrollment will be put on temporary halt(2)
10: Study will be (prematurely) ended(2)
11: Other
Serious deviation
1: Yes, report to Quality Assurance Amsterdam UMC and CTIS(4)
2: No
Deviation level(local)
2: Participant
3: Site
DeferConsent
1: Yes
2: No – participant deceased before consent in second instance was obtained
3: No – participant incapacitated to give consent
4: No – participant did not consent to study participation
YesNoNa
1: Yes
2: No
-2: Not applicable
No inclusion
1: Does not meet an inclusion criterion / does meet an exclusion criterion
2: Potential participant declines participation
3: Decision researcher
Gender
1: Man
2: Woman
3: Other
Etnicity
1: African (sub-Saharan)
2: Afro-Caribbean
3: Asian
4: Kaukasian
5: Indian/Pakistani/Bangladesh
6: Latin American
7: Arabic (Middle East and North Africa)
8: Other
-1: Unknown
Education
1: None
2: Primary school (lower education, special education)
3: Lower vocational education (e.g. LTS, LHNO, LEAO, domestic training school)
4: Lower general secondary education (e.g. VMBO, ULO, MULO, MAVO)
5: Secondary vocational education (e.g. MTS, MEAO, MHNO)
6: Senior general secondary education (e.g. HBS, MMS, HAVO, VWO, gymnasium)
7: Higher professional education (e.g. HTS, HEAO, HHNO)
8: University
9: Other
Smoking/Alco/Drugs
1: Yes
2: Yes, stopped
3: No
Alco unit
1: Day
2: Week
family medical history
1: Heart disease
2: Cancer
3: Genetic disorders
4: Other
Med_freq
15: Pro re nata (PRN = as needed)
1: Once daily
2: Twice daily
3: Three times a day
4: Four times a day
5: Every other day
6: Once weekly
7: Twice weekly
8: Once monthly
9: Twice monthly
10: Every two hours
11: Every four hours
12: Every six hours
13: Every eight hours
14: Continuous infusion
16: Other
Med_unit
1: Becquerel (Bq)
2: Centimetre (cm)
3: Centilitre (cl)
4: Decilitre (dl)
5: Drop (dr)
6: Unit (U/unit)
7: Gigabecquerel (GBq)
8: Gram (g)
9: International unit (IU)
10: Joule (J)
11: Kilobecquerel (KBq)
12: Kilocalories (kcal)
13: Kilogram (kg)
14: Mercury (Hg)
15: Litre (l)
16: Megabecquerel (MBq)
17: Microgram (mcg)
18: Microlitre (mcl)
19: Micromol (mcmol)
20: Milligram (mg)
21: Millilitre (ml)
22: Millimetre (mm)
23: Millimol (mmol)
24: Milli-osmol (mosmol)
25: Millisecond (msec)
26: Minute (min)
27: Nanomol (nmol)
28: Percentage (%)
29: Second (sec)
30: Piece (st)
31: Hour (hour)
32: Square metre body surface area (m^2)
33: Other