Term 1 of 214
The Investigator at your site asked you to review a protocol. The investigational product listed in
the protocol already has proven clinical benefits for the disease under study. This is considered
what type of trial?
Phase Iv Trial
Primary Variable
Exploratory Trial
Confirmatory Trial
Term 2 of 214
After completion of a study: where should the final trial close-out monitoring report prepared by
the CRA be filed?
before recruiting the first subject
consenting in the presence of figure of authority
in the Sponsor's files
1. the sponsor should appoint individuals: who are independent of the clinical trials/systems
2. regulatory authority(ies) should not routinely request this type of reports*
*(they may seek access to reports on a case by case basis when evidence of serious gcp
non-compliance exists: or in the course of legal proceedings)
,Term 3 of 214
What does ICH E11 say about long-term surveillance of children in clinical trials?
It is only required for adult participants
It should be avoided to minimize risk
It may be needed to determine the possible effects on development
It is not necessary for short-term studies
Term 4 of 214
A Clinical Research Coordinator (CRC) adjusted the dose of the Investigation Product (IP) for a
subject as the subject was suffering from Adverse Events (AEs) like headaches and vomiting.
When is a CRC allowed to do this task?
As long as the crc documents the change in the study records
Only when the CRC is a qualified physician and has been delegated this responsibility by
the PI
Whenever the subject requests a dose adjustment
If the crc believes the subject is experiencing side effects
Term 5 of 214
What must be done: at the site level: if the protocol is altered during the trial?
the protocol must be rewritten and submitted for new approval
the subjects must be reconsented and the irb/iec should be informed and approve the
changes if the trial is to continue
the subjects can be informed after the trial is completed
the changes can be implemented without notifying anyone
,Term 6 of 214
If sponsor's attempts to secure compliance have failed: and the monitoring/auditing identifies
serious and/or persistent noncompliance on the part of an investigator/institution: the sponsor
should
As soon as possible, but no later than SEVEN calendar days after first knowledge of the
event
1. Promptly notify the regulatory authority(ies)
2. Terminate the investigator's/institution's participation in the trial
1. Medical, pharmacy, dental, and nursing students:
2. Prisoners
3. Serving military personnel
Term 7 of 214
The term "severe" in ICH is used to describe
The Frequency of an event occurring.
The Duration of the event's impact.
The Intensity of a specific event
The overall outcome of a clinical trial.
, Definition 8 of 214
1. Results in death: is life threatening
2. Requires inpatient admission
3. Prolonged admission
4. Congenital anomaly
5. Persistent incapacity
6. Death itself is not neccessarily an SAE*
7. Must be reported by sponsor to authorities within 15 calendars days from sponsors first
knowledge of the event
*Seriousness does not equal severity in that Serious requires reporting while severe may not..
Severe may just be used to describe an AE
A site is screening potential subjects for a study looking at mild cognitive impairment. One
of the inclusion criteria is a score of 25 or less on a psychometric test: a research-specific
tool which measures cognitive ability. Which of the following individuals can administer the
psychometric test to the potential subjects?
Serious Adverse Event (SAE)
Who is responsible for providing the protocol
Adverse Event (AE)
Term 9 of 214
An unconscious adult subject was enrolled in a study after obtaining consent from an LAR: and
protocol therapy was initiated. The subject showed significant improvement in his clinical
condition: and regained consciousness. The Investigator should inform the subject about the
study and
The manufacturer of the product and/or the regulatory authorities
Obtain consent from the subject for the study
Non-inferiority study
Tell the subject that an lar provided consent for his participation
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