Responsibilities Flashcards

The DSMB has prematurely terminated a trial evaluating an investigational pain medication hat is taken one caplet orally b.i.d. for chronic hip pain. Subject are allowed to take one extra caplet per day. Subjects receive a sufficient quantity of IP for 14 days plus two additional doses. Which of the following represents a drug accountability issue?

Answer: Subject B returns 12 pills after 8 days on the trial

The subject was instructed to take 8 tablets per day (2 tablets * 4 times/day). By the morning of day 9, they had completed 8 full days of dosing, meaning they should have taken 8 * 8 = 64 tablets. They were issued 120 tablets and returned 88, indicating they took 120 - 88 = 32 tablets. Compliance is calculated as (Actual tablets taken / Expected tablets taken) * 100 = (32 / 64) * 100 = 50%.

A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he?

Answer: 50%

If 92 bottles are available for the CRC to return from an initial supply of 100 bottles, it means that 8 bottles were ultimately not returned (100 - 92 = 8). This implies that despite 26 subjects being enrolled and each receiving two bottles (52 bottles dispensed), only 8 bottles were consumed or otherwise unaccounted for, with the remaining dispensed bottles being returned unused.

Twenty-six subjects were enrolled in a pneumonia trial. The site received 100 bottles of IP. Each subject received two bottles. How many bottles are available for the CRC to return to the sponsor at the end of the trial?

Answer: 92

A double-blind trial is characterized by neither the subjects nor the investigators (clinical team) knowing which treatment is being administered. In this scenario, the pharmacist and sponsor know the IP identity, but the pharmacist has no direct contact with the subject or clinical team, ensuring that both the subject and the clinical staff interacting with them are unaware of the treatment assignment.

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 subject and the clinical team. Which of the following BEST describes this trial type?

Answer: double-blind

Phase 1 clinical trials are the initial human studies for a new drug, primarily focused on safety and basic pharmacological properties. 'Dose escalation' is a key component, gradually increasing the dose to find a safe and tolerable range. 'Pharmacokinetic analysis' is also crucial, as it studies how the drug is absorbed, distributed, metabolized, and excreted in the body, providing essential information for subsequent trial phases.

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: pharmacokinetic analysis

To convert weight from pounds (lb) to kilograms (kg), you divide the weight in pounds by the conversion factor of approximately 2.20462. Therefore, 123 lb / 2.20462 lb/kg ≈ 55.79 kg, which rounds to 56 kg.

If the patient's weight is 123 lb, what is the weight in kg?

Answer: 56

The regulatory binder must contain all essential trial documents. When a protocol is amended, the 'amended protocol' itself is required to detail the changes. Additionally, an 'IRB/IEC letter of approval for the amended protocol' is crucial to document ethical oversight. The 'Investigator's Brochure' (IB), providing comprehensive information about the investigational product, is a fundamental document that must always be included in the binder.

The protocol and protocol summary have been submitted to a central IRB/IEC for review/approval by the CRO prior to the investigator's 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: an IRB/IEC letter of approval for the amended protocol

In a purely competitive market, products are undifferentiated, and firms are price takers. Strategies like lean manufacturing, process reengineering, and supply chain management focus on cost efficiency. Developing a brand name aims to differentiate a product and build customer loyalty, which is a strategy for markets with some degree of monopolistic competition, not a purely competitive market where products are homogeneous.