Practice Questions Flashcards

1
Q

Who is responsible for signing off a completed Case Report Form (CRF)?

A

Investigator or authorized personnel

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

How can AEs be described?

A
  • Reported in previous clinical or pre-clinical trials
  • Consistent with applicable product information
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Which is necessary to contact the IRB/IEC?

A

When a serious unexpected adverse drug reaction occurs (SADRs)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Who’s responsibility is it to safeguard the rights and safety of subjects in clinical trials?

A

The investigator

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Who does the investigator need to inform if they deviate from the protocol?

A
  • Regulatory authorities
  • Sponsor
  • IRB/IEC
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Who should have access to trial files?

A
  • Monitor
  • Investigator
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

An AE that is severe in intensity-

A

May not meet the definition of serious

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Which is always true-

A

An adverse drug reaction is an adverse event

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

When is verbal consent prior to participation in a research study permitted?

A

When the subject is illiterate

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Which is only filed in the investigator’s files?

A

Signed informed consent forms

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Who is permitted to enter data into the case report form?

A
  • Any person delegated by the investigator to carry out this task
  • The investigator
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Investigator documented and explained to sponsor premature unblinding that occurred in the trial. When does unblinding occur?

A

When the investigator wants to make sure a particular subject is not randomized to placebo in case of a SAE

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Subject calls CRC 1 week before next scheduled visit to report pea-sized lump in neck. What should CRC do first?

A

Schedule subject on-site for an interim assessment

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Small biotech company investigating an anti-tumoral property of scorpion toxin. After animal trials, the first trial in humans would likely involve-

A
  • PK analysis
  • Placebo control
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Responsibilities of IDMC/DSMB?

A
  • Assess the progress of a trial
  • Recommend stopping a trial
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Which requires prior consent when screening a subject?

A

Washout from medication

17
Q

The trough blood level for a once-daily drug should be drawn how long after last dose?

A

24 hours

18
Q

Clinical trial being conducted to determine safety and tolerability of a new anti-emetic IP. Sponsor expects to enroll 20 subjects. This would be considered-

A

Phase 1 trial

19
Q

Plasma contains

A

Fibrinogen, albumin and platelets

20
Q

Serum contains

A

Albumin and globulin

21
Q

45 year old man drinking alcohol heavily during past week complains of vomiting, nausea and abdominal pain. Lab results suggest acute pancreatitis-

A

Elevated lipase

22
Q

Acute hepatitis is suggested by

A

High SGOT and ALT

23
Q

50 year old diagnosed with acute bacterial pneumonia. Acute bacterial infection is suggested by

A

High neutrophil levels