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
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
YesNo
1: Yes
2: No
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