1. Clinical trail methodology has changed over time, and regulations have become more strict. There is currently international endavours to review the results of previous clinical trials.
One of the item that could be of concern is the previous practice of limiting trial enrollment to men between the ages of 18-65. If a drug was approved based on the results of trials with only adult male participants, which of the following statements could be made:
The drug can continue to be prescribed to the adult population with no concerns
Male children can be safely prescribed this medication if the dose is decreased based on weight.
If the data is monitored appropriately during the trial, the drug should be safe
There may be possible differences in the effectiveness and the safety profile of the drug in women.
2. Select if the following statement is true or false:
Regulatory authorities mandate that trials must be undertaken in the population in which they will be used. This means that Sponsors does not need to include children in the trial if the product will only be used in an adult population.
True
False
3. You are a recent graduate of the Clinical Research Program, and are hired to be a Monitor for a well-known pharmaceutical company.
This company is undertaking a Phase III trial that is being conducted in 10 centres across North America. the pharmaceutical company send you to the study sites to undertake monitoring. The next 6 questions pertain to various scenarios that you encounter during your monitoring visits.
At your first study site, you learn that there are multiple research coordinators working on the study and they all share a laptop. The laptop is not password protected and the coordinators often sign the laptop out to take home over the weekend.
This could potentially:
Negatively impact the protection of human subjects
Negatively impact the integrity of the data
Not impact the trial
4. You then learn that there has been 3 new research coordinators in the past year who have joined the study. The Principal Investigator identifies that all new research staff are trained on the study, have Good Clinical Practice training and have previous educational or work experience in clinical research.
This could potentially:
Negatively impact the protection of human subjects
Negatively impact the integrity of the data
Not impact the trial
5. At the next study site, you are reviewing the data submitted against the patient's medical records.
The data entry requires that the lab values be converted from conventional (US) units to SI units.
After reviewing a few charts, you feel that the data submitted does not appear to match the data on the medical records. On closer examination, you realize that the conversions are not correct: it appears that the data manager at the study site was converting the values for "Creatinine" using the conversion for "creatine".This lab value was being collected to evaluate the renal health of participants.(not sure)
This could potentially:
Negatively impact the protection of human subjects
Negatively impact the integrity of the data
Not impact the trial
Negatively impact the protection of human subjects and negatively impact the integrity of the data. It could also
6. The trial requires that patients attend weekly clinic visits during the 2-month period in which they are receiving the intervention. (not sure)
At the third study site, you notice that the patient visits for the week of December 25th have all been scheduled between Tuesday to Thursday.
You flip to the week prior and notice that there are patients receiving the intervention who were scheduled in throughout the week (Monday through Friday). You refer to the protocol, section titled "Allowable Delays and Deviations". In this section, you see that study participants are allowed to receive the intervention within 30 hours before or after of the scheduled time. All of the visits from the week of December 25th meet this criteria.
You conclude that the re-scheduling of patients will:
Negatively impact the protection of human subjects
Negatively impact the integrity of the data
Not impact the trial
Negatively impact the protection of human subjects and negatively impact the integrity of the data
7. The study requires that study participants undergo echocardiograms at 6-month intervals from the time of enrollment to 2 years after the intervention is complete to ensure that there is no cardiac dysfunction that arises. Cardiac dysfunction would result in discontinuation of the drug, and potentially require treatment based on the severity of the dysfunction.
During the period of the intervention, you see that the study participants follow the schedule. However after the intervention has stopped, the study participants only have echocardiograms at 1-year intervals.
This could potentially:
Negatively impact the protection of human subjects
Negatively impact the integrity of the data
Not impact the trial
Negatively impact the protection of human subjects and negatively impact the integrity of the data
8. At the last study site, you are investigating the investigational product (IP). This includes reconciling the IP dispensed with the medication administered. You also look at the area in which the IP is stored. The IP is supposed to be kept in a fridge, at a temperature of 2-8 degrees celsius.The temperature log indicates that the temperature was maintained at 5C. However, there was one day in which the temperature was raised to 10 degrees celsius.
You raise this with the research pharmacist. They confirm that there was a power-failure for a few hours one afternoon and the fridge was not on a back-up generator. This resulted in the temperature rose to 10C. The research pharmacist had however transferred the IP at the time of the power failure to an alternate fridge that did have a back-up generator. The logs of the alternate fridge indicate that the temperature was 4C throughout the time.
This scenario could potentially:
Negatively impact the protection of human subjects
Negatively impact the integrity of the data
Not impact the trial
Negatively impact the protection of human subjects and negatively impact the integrity of the data
9. A CRA’s role can vary, depending on the phase of the study. Match the phase to the specific duties. Each answer applies to only one statement.
Partial marks will be awarded.
Phase I bioequivalence study
Phase I
Phase II
Phase III
Post-marketing studies
A. Efficacy is the focus, although safety is important and risk management strategies will dictate the monitoring visit schedule – Phase 2
B. Witness the dispensing of Investigational Product to the subject, blood draws and check the processing of samples – Phase 1 bioequivalence study
C. Close, frequent monitoring, with a primary focus on safety – Phase 1
D. Monitoring occurs less frequently as the overall efficacy and safety of the IP has been established – Post-monitoring studies.
E. Fewer in-person visits, as monitoring can occur with centralized monitoring (electronic Case Report Forms). Visits often will include a discussion on recruitment strategies – Phase 3
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