MCQs on Good Documentation Practices

Q1: According to GCP, source documents should be:

Stored securely for required retention period
Amended using a single line-through method
Original documents completed during trial
All of the above

Q2: Corrections to source documents should include which elements according to GCP?

Initials and date of person making correction
Explanation for correction
Original entry history
All of the above

Q3: According to GCP, how should records containing adverse event information be documented?

In patient’s medical history
In source documents and CRFs
Verbatim in investigator notes
As summary in sponsor reports

Q4: According to GCP, source documents should be: (Q4)

Stored securely for required retention period
Amended using a single line-through method
Original documents completed during trial
All of the above

Q5: Corrections to source documents should include which elements according to GCP? (Q5)

Initials and date of person making correction
Explanation for correction
Original entry history
All of the above

Q6: According to GCP, how should records containing adverse event information be documented? (Q6)

In patient’s medical history
In source documents and CRFs
Verbatim in investigator notes
As summary in sponsor reports

Q7: According to GCP, source documents should be: (Q7)

Stored securely for required retention period
Amended using a single line-through method
Original documents completed during trial
All of the above

Q8: Corrections to source documents should include which elements according to GCP? (Q8)

Initials and date of person making correction
Explanation for correction
Original entry history
All of the above

Q9: According to GCP, how should records containing adverse event information be documented? (Q9)

In patient’s medical history
In source documents and CRFs
Verbatim in investigator notes
As summary in sponsor reports

Q10: According to GCP, source documents should be: (Q10)

Stored securely for required retention period
Amended using a single line-through method
Original documents completed during trial
All of the above

Q11: Corrections to source documents should include which elements according to GCP? (Q11)

Initials and date of person making correction
Explanation for correction
Original entry history
All of the above

Q12: According to GCP, how should records containing adverse event information be documented? (Q12)

In patient’s medical history
In source documents and CRFs
Verbatim in investigator notes
As summary in sponsor reports

Q13: According to GCP, source documents should be: (Q13)

Stored securely for required retention period
Amended using a single line-through method
Original documents completed during trial
All of the above

Q14: Corrections to source documents should include which elements according to GCP? (Q14)

Initials and date of person making correction
Explanation for correction
Original entry history
All of the above

Q15: According to GCP, how should records containing adverse event information be documented? (Q15)

In patient’s medical history
In source documents and CRFs
Verbatim in investigator notes
As summary in sponsor reports

Q16: According to GCP, source documents should be: (Q16)

Stored securely for required retention period
Amended using a single line-through method
Original documents completed during trial
All of the above

Q17: Corrections to source documents should include which elements according to GCP? (Q17)

Initials and date of person making correction
Explanation for correction
Original entry history
All of the above

Q18: According to GCP, how should records containing adverse event information be documented? (Q18)

In patient’s medical history
In source documents and CRFs
Verbatim in investigator notes
As summary in sponsor reports

Q19: According to GCP, source documents should be: (Q19)

Stored securely for required retention period
Amended using a single line-through method
Original documents completed during trial
All of the above

Q20: Corrections to source documents should include which elements according to GCP? (Q20)

Initials and date of person making correction
Explanation for correction
Original entry history
All of the above

Q21: According to GCP, how should records containing adverse event information be documented? (Q21)

In patient’s medical history
In source documents and CRFs
Verbatim in investigator notes
As summary in sponsor reports

Q22: According to GCP, source documents should be: (Q22)

Stored securely for required retention period
Amended using a single line-through method
Original documents completed during trial
All of the above

Q23: Corrections to source documents should include which elements according to GCP? (Q23)

Initials and date of person making correction
Explanation for correction
Original entry history
All of the above

Q24: According to GCP, how should records containing adverse event information be documented? (Q24)

In patient’s medical history
In source documents and CRFs
Verbatim in investigator notes
As summary in sponsor reports

Q25: According to GCP, source documents should be: (Q25)

Stored securely for required retention period
Amended using a single line-through method
Original documents completed during trial
All of the above

Q26: Corrections to source documents should include which elements according to GCP? (Q26)

Initials and date of person making correction
Explanation for correction
Original entry history
All of the above

Q27: According to GCP, how should records containing adverse event information be documented? (Q27)

In patient’s medical history
In source documents and CRFs
Verbatim in investigator notes
As summary in sponsor reports

Q28: According to GCP, source documents should be: (Q28)

Stored securely for required retention period
Amended using a single line-through method
Original documents completed during trial
All of the above

Q29: Corrections to source documents should include which elements according to GCP? (Q29)

Initials and date of person making correction
Explanation for correction
Original entry history
All of the above

Q30: According to GCP, how should records containing adverse event information be documented? (Q30)

In patient’s medical history
In source documents and CRFs
Verbatim in investigator notes
As summary in sponsor reports

Q31: According to GCP, source documents should be: (Q31)

Stored securely for required retention period
Amended using a single line-through method
Original documents completed during trial
All of the above

Q32: Corrections to source documents should include which elements according to GCP? (Q32)

Initials and date of person making correction
Explanation for correction
Original entry history
All of the above

Q33: According to GCP, how should records containing adverse event information be documented? (Q33)

In patient’s medical history
In source documents and CRFs
Verbatim in investigator notes
As summary in sponsor reports

Q34: According to GCP, source documents should be: (Q34)

Stored securely for required retention period
Amended using a single line-through method
Original documents completed during trial
All of the above

Q35: Corrections to source documents should include which elements according to GCP? (Q35)

Initials and date of person making correction
Explanation for correction
Original entry history
All of the above

Q36: According to GCP, how should records containing adverse event information be documented? (Q36)

In patient’s medical history
In source documents and CRFs
Verbatim in investigator notes
As summary in sponsor reports

Q37: According to GCP, source documents should be: (Q37)

Stored securely for required retention period
Amended using a single line-through method
Original documents completed during trial
All of the above

Q38: Corrections to source documents should include which elements according to GCP? (Q38)

Initials and date of person making correction
Explanation for correction
Original entry history
All of the above

Q39: According to GCP, how should records containing adverse event information be documented? (Q39)

In patient’s medical history
In source documents and CRFs
Verbatim in investigator notes
As summary in sponsor reports

Q40: According to GCP, source documents should be: (Q40)

Stored securely for required retention period
Amended using a single line-through method
Original documents completed during trial
All of the above

Q1: According to GCP, source documents should be:

Q2: Corrections to source documents should include which elements according to GCP?

Q3: According to GCP, how should records containing adverse event information be documented?

Q4: According to GCP, source documents should be: (Q4)

Q5: Corrections to source documents should include which elements according to GCP? (Q5)

Q6: According to GCP, how should records containing adverse event information be documented? (Q6)

Q7: According to GCP, source documents should be: (Q7)

Q8: Corrections to source documents should include which elements according to GCP? (Q8)

Q9: According to GCP, how should records containing adverse event information be documented? (Q9)

Q10: According to GCP, source documents should be: (Q10)

Q11: Corrections to source documents should include which elements according to GCP? (Q11)

Q12: According to GCP, how should records containing adverse event information be documented? (Q12)

Q13: According to GCP, source documents should be: (Q13)

Q14: Corrections to source documents should include which elements according to GCP? (Q14)

Q15: According to GCP, how should records containing adverse event information be documented? (Q15)

Q16: According to GCP, source documents should be: (Q16)

Q17: Corrections to source documents should include which elements according to GCP? (Q17)

Q18: According to GCP, how should records containing adverse event information be documented? (Q18)

Q19: According to GCP, source documents should be: (Q19)

Q20: Corrections to source documents should include which elements according to GCP? (Q20)

Q21: According to GCP, how should records containing adverse event information be documented? (Q21)

Q22: According to GCP, source documents should be: (Q22)

Q23: Corrections to source documents should include which elements according to GCP? (Q23)

Q24: According to GCP, how should records containing adverse event information be documented? (Q24)

Q25: According to GCP, source documents should be: (Q25)

Q26: Corrections to source documents should include which elements according to GCP? (Q26)

Q27: According to GCP, how should records containing adverse event information be documented? (Q27)

Q28: According to GCP, source documents should be: (Q28)

Q29: Corrections to source documents should include which elements according to GCP? (Q29)

Q30: According to GCP, how should records containing adverse event information be documented? (Q30)

Q31: According to GCP, source documents should be: (Q31)

Q32: Corrections to source documents should include which elements according to GCP? (Q32)

Q33: According to GCP, how should records containing adverse event information be documented? (Q33)

Q34: According to GCP, source documents should be: (Q34)

Q35: Corrections to source documents should include which elements according to GCP? (Q35)

Q36: According to GCP, how should records containing adverse event information be documented? (Q36)

Q37: According to GCP, source documents should be: (Q37)

Q38: Corrections to source documents should include which elements according to GCP? (Q38)

Q39: According to GCP, how should records containing adverse event information be documented? (Q39)

Q40: According to GCP, source documents should be: (Q40)

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