A CRA is preparing to conduct a pre-study visit. Which of the following documents should be the BEST resource for answers to the investigator's questions regarding the rationale for investigating the investigational product, the dose and regimen, and the risk/benefit ratio?
Phase 1 Study Reports
Investigator's Brochure
Sample Informed Consent Form
Investigators' Meeting Handouts
Who is responsible for the investigational product at a site during the study?
The Sponsor
The Monitor
The Investigator
The Pharmacist
An Investigator is reviewing a protocol for a Phase 1 study. Which one of the following is most likely to be its objective? To determine the...
... safety and efficacy of agent "X" versus placebo in alleviating pain in patients with osteoarthritis.
... therapeutic dosage of an investigational product in reducing soft tissue inflammation following third molar extractions.
... dosage at which caffeine enhances acetylsalicylic acid absorption in normal, healthy volunteers.
... PSA levels over time in patients with benign prostatic hypertrophy treated with a herbal extract.
Potentially vulnerable subjects who require special consideration by an IRB/IEC include which of the following?
1. Medical, pharmacy, dental, and nursing students 2. Prisoners 3. Elderly patients living at home 4. Serving military personnel
2, 3 and 4 only
1, 2 and 3 only
1, 2 and 4 only
1, 3 and 4 only
All of the following are likely stratification factors in a randomization schedule EXCEPT:
Glucose Level
Caloric Intake
Disease Severity
Prior Study Participation
A protocol for a new drug for the treatment of cystic fibrosis (CF) excludes patients who have received either antibiotics or corticosteroids within 2 weeks of screening, as well as patients who have started a new chronic medication for CF within 2 weeks of screening. Using these criteria, which of the following patients would be INELIGIBLE to participate in this study?
A patient who was diagnosed 2 weeks ago with allergic rhinitis for which a nasal antihistamine was prescribed to be taken on a p.r.n. basis.
A patient who was admitted to the hospital one month ago and was put on IV antibiotics for a pulmonary infection and discharged after 3 days with a 1-week course of oral antibiotics.
A patient who is on longstanding treatment with prednisone to maintain pulmonary functions.
A patient who was seen in the emergency department 10 days ago for symptoms presenting as a migraine headache. The patient was treated with an injection of pethidine and discharged.
Which of the following must be described in a protocol?
Information on the bio-availability of the investigational product.
Names and addresses of the responsible independent ethic committee(s).
The statistical methods to be employed.
The quality assurance auditing procedures.
When reviewing a protocol, the schedule of study events would most likely be presented in?
1. The Protocol 2. The Investigator's Brochure 3. An Appendix to the Protocol 4. The Informed Consent Form
1 and 2 only
1 and 3 only
2 and 4 only
3 and 4 only
A crossover design is BEST described as a study...
... with a placebo run-in.
... where only responders receive long term therapy.
... where subjects receive all study treatments at different times.
... where each dose of investigational product has a matching placebo.
According to ICH GCP, the best description of an AE or ADR that is serious is one which is...
Fatal or life-threatening, results in or prolongs inpatient hospitalization, results in persistent disability/incapacity, a congenital anomaly/birth defect.
All of the above plus cancer and overdose.
Fatal and life-threatening only.
An overdose of the study drug.
A study subject develops drug-induced nephritis and is admitted to the hospital. Which answer describes this situation best?
An adverse drug reaction.
An unexpected adverse drug reaction.
A serious adverse drug reaction.
a life-threatening adverse drug reaction.
During a clinical trial, which of the following are considered Serious Adverse Events?
1. Prolonged hospital stay because of an infection following surgery 2. Hospital admission following a motor vehicle accident 3. Severe rash 4. Pregnancy resulting in the normal delivery of twins
Which of the following are considered tasks that the CRC would complete prior to a routine monitoring visit by a CRA?
1. Review the CRFs to ensure all data to date has been transcribed. 2. Enter all projected visit dates on the enrollment log. 3. Record investigational product dispensation completed to date. 4. Send the original CRF pages to the CRA for review.
2 and 3 only
When training the investigator on a phase 3 trial, which of the following protocol sections is MOST important to emphasize?
The statistical plan.
The pre-clinical data.
The publication policy.
The efficacy variables.
At the close-out visit, the CRA notices that a subject has omitted information on a baseline diary. Which of the following is the BEST advice for the CRA to give the investigator?
Ask the subject to complete the diary now.
Fill in the information based on subsequent data.
Discard the incomplete diary.
Document this information as missing.
What action should be taken by the investigator or subinvestigator for any discrepancies between source documents and CRF?
Highlight with a fluorescent pen.
Refer to the IRB/IEC.
Provide an explanation.
No action required.
Investigators must send the IRB/IEC the following reports:
Annual progress report
Monitoring visit report
Study initiation report
Patient enrollment tracking report
ICH GCP requires an investigator to provide the IRB/IEC with all of the following EXCEPT:
Details of expenses that will be paid to subjects.
Significant protocol changes.
Names of all subjects whose participation in the study is terminated prematurely.
A written explanation if a study is terminated or suspended by the sponsor.
A document on which the subject records their consumption of study medication at home is called a:
Case report form
Subject enrollment log
Subject diary
Investigational product accountability log
A CRA is responsible for which of the following during a monitoring visit?
1. Verifying subject protection 2. Confirming data recorded are verifiable from source documents 3. Reviewing medical charts for potential subjects 4. Ensuring protocol compliance
An investigator is about to start a trial with seriously ill patients. He encounters a subject in a life-threatening situation for which no standard acceptable treatment is available. The investigator believes that the investigational drug may benefit this patient, who is unconscious and time is not sufficient to obtain informed consent from a legally acceptable representative. The investigator determines that the investigational drug is the only means available to increase the possibility of preserving the patient's life and decides to administer the investigational product. According to ICH GCP, which of the following is true in relation to the IRB/IEC and their approval (favorable opinion) about this emergency use:
Under no circumstances can unconscious patients be enrolled without either their consent or that of their legally acceptable representative.
A physician who is independent of the trial must confirm the need to treat the unconscious patient with the investigational product.
The investigator is responsible for medical care of trial subjects so can enroll unconscious patients without prior IRB/IEC approval.
Documented approval or favorable opinion from the IRB/IEC is needed for a protocol involving unconscious patients before they can be enrolled.
The PRIMARY responsibility of an IRB/IEC is to:
Evaluate the liability of the investigator.
Ensure all participating subjects are protected.
Ensure all participating subjects sign an informed consent form.
Verify the risk/benefit ratio of the investigational product.
Which of the following are Essential Documents held in a site's Trial Master File?
1. List of staff to whom the Investigator has delegated significant trial related duties. 2. Investigational product accountability records. 3. Subject screening logs. 4. Signed informed consent forms.
An IRB/IEC is required to retain records for at least how many years after completion of a trial?
2 years
3 years
5 years
10 years
When the investigator or his/her team make changes or corrections to a CRF, which action should they take?
Over-write the original entry.
Write them in red ink in the margin.
Ensure that they are all explained.
Initial and date each correction.
An experienced PI was not available to attend the investigator's meeting for a multi-center study. The PI now discovers a conflict prohibiting attendance at the site initiation meeting, but all other study team members are confirmed to attend in 2 days time. Which of the following is the best course of action?
Reschedule the initiation meeting.
Confirm that the investigator's experience with the investigational product is current.
Hold the initiation meeting as scheduled and review content with the investigator at the earliest opportunity.
Request that study staff review the initiation meeting content with the investigator and produce meeting minutes.
A subject is reviewing an informed consent for a hypertension study with the CRC. The consent includes a lengthy paragraph on discomforts and risks. The subject remarks about this and is concerned. Which of the following is the MOST appropriate response?
The regulatory authorities require that all known and possible side effects be listed.
Hypertension medications can cause numerous side effects, but most are not serious.
The investigator will be available to answer your questions before the screening examination starts.
This is a reference list for collecting relevant data on adverse events occurring during the study.
Which is the most important document when preparing for an audit?
Monitoring Guidelines
Trial Master File
Trial Protocol
What is a non-clinical study?
A study performed outside a clinic (e.g., at a general practitioner or in a Phase 1 Center).
A study not performed on human subjects.
A study performed in healthy volunteers.
A study using an external medical device in patients with heart disease.
Quality control of clinical trials by sponsors includes:
1. The use of SOPs 2. Pre-trial visits to assess suitability of sites 3. Monitoring visits 4. Inspections
1, 2 and 3
1, 2 and 4
1, 3 and 4
2, 3 and 4
Who has ultimate responsibility for the quality and integrity of the data in a contracted trial?
The Contract Research Organization
The Regulatory/Competent Authority
An Independent Data Monitoring Committee
In addition to being familiar with the different types of questions on your upcoming certification exam, all of the following steps should also be taken in preparing for your certification exam EXCEPT:
Assess your readiness for the exam.
Block out time for studying .
Check the 5 relevant guidelines and detailed contact outline.
Delay making any plans.
