Practice Exam

Question 1

A subject is participating in a clinical trial where only the pharmacist and the sponsor know the identity of the IP. The pharmacist has no direct contact with the trial subjects and clinical team. Which of the following BEST describes this trial type?

Answer 1

Double blind

Question 2

A clinical trial is being conducted to determine the safety and tolerability of a new anti-emetic IP. The sponsor expects to enroll 20 subjects. This would be considered a-

Answer 2

Phase 1

Question 3

A small biotech company is investigating the anti-tumoral potential of scorpion toxin in high grade recurrent brain tumors. After animal trials have been completed, the first trial in humans would most likely involve-

Answer 3

• PK sampling
• Dose escalation

Question 4

In an effort to increase enrollment in an ongoing trial, the sponsor has broadened inclusion/exclusion criteria to increase the allowable creatinine level. The next step the CRC should take is to-

Answer 4

Notify the IRB/IEC of the change

Question 5

A subject is participating in a lipid-lowering clinical trial. Before his 12-month visit, the CRC receives an amendment from the sponsor that includes an outcomes measurement at the 12-month visit. The CRC should FIRST provide the subject with which of the following?

Answer 5

A revised consent form

Question 6

The protocol and protocol summary have been submitted to a central IRB/IEC for review/approval by the CRO prior to the investigators’ meeting. Following the meeting, the entry criteria are altered to facilitate the recruitment and retention of eligible subjects. Prior to trial start-up, the regulatory binder must include-

Answer 6

-IRB/IEC letter of approval for the amended protocol
- The amended protocol
- The Investigator’s brochure

Question 7

Which of the following is a liver function test?
- TSH
- LDH
- BUN
- Hct

Answer 7

LDH

Question 8

At the month 3 visit of a Phase III double-blind trial, the subject informs the CRC that he was seen in the emergency department for an anaphylactic reaction. The subject states “the doctor told me I was very lucky. I might have died.” Having this information, the MOST appropriate sequence of action is to inform the-

Answer 8

PI, sponsor and IRB/IEC

Question 9

Which of the following are considered SAEs?
1. Infection following surgery prolonging hospital stay
2. Pregnancy resulting in normal delivery of twins
3. Boating accident with overnight hospitalization
4. Use of illicit drug during the trial

Answer 9

1 and 3 only

Question 10

A subject is admitted to the hospital for chest pain and suspected myocardial infarction. The subject gave informed consent for a trial of a new antihistamine 1 week before the onset of any chest pain. The subject took the first dose of test article 2 days ago. The PI determines the event is probably related to the IP. Which of the following is the BEST course of action for the CRC to take?

Answer 10

Notify the sponsor that the PI believes the event is related to the IP

Question 11

A subject in a Phase 1 oncology trial experiences nausea with vomiting after IP infusion which results in an inpatient hospitalization. Nausea with vomiting does not appear in the Investigator’s Brochure. The investigator should rate this event as-

Answer 11

Unexpected and serious

Question 12

Which of the following are responsibilities of an IDMC/DSMB?
1. Assess the financial aspects of a trial
2. Assess the progress of a trial
3. Recommend initiating a trial
4. Recommend stopping a trial

Answer 12

2 and 4 only

Question 13

A site has not received IRB/IEC approval for a protocol submission. The PI instructs the CRC employed by the clinic to begin scheduling subjects for screening appointments. Which of the following is the BEST action for the CRC to take?

Answer 13

Review the research database and collate a list of potential subjects

Question 14

All of the following are regulatory documents EXCEPT

Answer 14

Confidentiality agreement

Question 15

The day before a CRA is to conduct an initiation visit, the CRC realizes that the IRB/IEC approval letter has not yet been obtained. Which of the following should the CRC do FIRST?

Answer 15

Call the IRB/IEC to check the status of the letter

Question 16

Subjects in a prostate trial are required to undergo four chest x-rays over a 4-week period. To ensure the subject understands safety issues, the IRB/IEC would be MOST concerned that the subject is informed of the-

Answer 16

Risks of the additional radiation

Question 17

A subject presents at a site with her husband after pre-qualifying on a phone screen. She states she is legally blind and cannot read the ICF. A Braille ICF is not available. The subject is able to sign her name if her hand is guided to the signature line. Which of the following is the BEST course of action to obtain legal consent for this subject?

Answer 17

The subject and an impartial witness can sign the ICF after it is read to them and she verbally states her understanding.

Question 18

A subject has signed the informed consent form for a hypertension trial. All screening procedures and the physical exam have been completed. The CRC is ready to dispense the single-blind placebo to the subject who asks “ Is that the sugar pill that I read about in the form I signed?” Which of the following should the CRC tell the subject?

Answer 18

It might be the placebo, but we will be checking your blood pressure every week

Question 19

A CRC is enrolling three subjects for a Phase III trial with restrictive eligibility criteria. The PI indicates that she must leave the office to teach a lecture in 30 minutes. The laboratory will be closing in 1 hour. Which of the following is the MOST appropriate action for the CRC?

Answer 19

Give each subject sufficient time to review the ICF

Question 20

Which of the following would require prior consent when screening a subject?

Answer 20

Washout from medication

Question 21

A hypertension trial protocol indicates that subjects should not be randomized on Fridays or Saturdays. During subject screening, a subject meeting all entry criteria is identified. However, the only day that this subject is available for clinic visits is Friday due to his work schedule. The CRC should-

Answer 21

Contact the sponsor regarding the subject’s time conflict

Question 22

A clinical trial is being conducted for hormone replacement. The trial includes a diary. Which of the following would be considered an objective parameter?

Answer 22

Episodes of vaginal bleeding

Question 23

During the monitoring visit, a CRA discusses the following queries with the CRC:
- Dates of the subject visits recorded in incorrect format
- Subjects’ identification numbers are missing lead-in zeros
- Weights are recorded as pounds instead of kilograms
- Discrepancies in the two subjects’ visit dates between source data and CRF entries
Which of the following actions should the CRC take?

Answer 23

Correct errors on the CRFs as discovered