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SOCRA 2023 > ICH > Flashcards

ICH Flashcards

1
Q

A systematic and independent examination of trial related activities and documents to determine whether the trial related activites were conducted and the data were recorded according to the protocol, sponsor’s SOP, and GCP

A

Audit

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2
Q

A compilation of the clinical and nonclinical data on the investigational product(s)

A

Investigator’s Brochure (IB)

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3
Q

A person or an organization contracted by teh sponsor to perform one of more of a sponsor’s trial related duties and functions

A

Contract Research Organization (CRO)

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4
Q

All noxious and unintended responses to a medicinal product related to any dose

A

Adverse Drug Reaction (ADR)

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5
Q

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced

A

Essential documents

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6
Q

Any untoward medical occurrence in a patient or subject which does not necessarily have a causal relationship with this treatment

A

Adverse Event (AE)

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7
Q

A person, who is independent of the trial, who cannot be unfairly influenced by peopled involved with the trial

A

Impartial witness

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8
Q

The act by regulatory authorities of conducting an official review of documents, facilities, records and any other resources that are deemed to be related to the clinical trial

A

Inspection

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9
Q

Audit

A

A systematic and independent examination of trial related activities and documents to determine whether the trial related activites were conducted and the data were recorded according to the protocol, sponsor’s SOP, and GCP

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10
Q

Investigator’s Brochure (IB)

A

A compilation of the clinical and nonclinical data on the investigational product(s)

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11
Q

Contract Research Organization (CRO)

A

A person or an organization contracted by teh sponsor to perform one of more of a sponsor’s trial related duties and functions

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12
Q

Adverse Drug Reaction (ADR)

A

All noxious and unintended responses to a medicinal product related to any dose

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13
Q

Essential documents

A

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced

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14
Q

Adverse Event (AE)

A

Any untoward medical occurrence in a patient or subject which does not necessarily have a causal relationship with this treatment

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15
Q

Impartial witness

A

A person, who is independent of the trial, who cannot be unfairly influenced by peopled involved with the trial

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16
Q

Inspection

A

The act by regulatory authorities of conducting an official review of documents, facilities, records and any other resources that are deemed to be related to the clinical trial

17
Q

How quickly should SAEs be reported to the study sponsor upon awareness of the event

A

Immediately

18
Q

Examples of what classifies as a SAE

A
  • inpatient hospitalization or prolongation of existing hospitalization
  • death
  • life threatening
  • significant disability/incapacity or congenital anomaly/birth defect
19
Q

To what entity may the sponsor transfer trial-related duties or functions

A

Contract Research Organization (CRO)

20
Q

If a sponsor transfer duties to a CRO, who holds responsibility for the quality and integrity of the trial data

A

Sponsor

21
Q

Who holds responsibility for IP (investigational product) accountability

A

The investigator/institution

22
Q

How frequently should IRB/IEC (**What is IEC??) conduct continuing review

A

at least once per year, at intervals appropriate to the degree of risk to human subjects

23
Q

How long must the iRB retain records of the trial

A

at least 3 years

24
Q

How long should the investigator retain essential documents of the trial

A

at least 2 years after the last approval of a marketing application in an ICH region

25
Q

How long should IP essential documents be retained by the sponsor after trial closure

A

at least 2 years

26
Q

How should investigators be qualified?

A

Education, AND training, AND experience

27
Q

What does Good Manufacturing Practice (GMP) dictate

A

How IP is
- manufactured
- handled
- stored

28
Q

What are the appropriate actions of the investigator after a deviation occurs

A

Document and explain

29
Q

What should investigators immediately report to the IRB

A
  • Violations
  • Changes to risks to subjects
  • Adverse drug reactions that are both serious and unexpected

**Check for more

30
Q

What does ICH stand for

A

International Counsel for Harmonization

SOCRA 2023 (12 decks)

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