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?
Correct!Wrong!
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?
Correct!Wrong!
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:
Please select 2 correct answers
Correct!Wrong!
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?
Correct!Wrong!
If the patient's weight is 123 lb, what is the weight in kg?
Correct!Wrong!
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?
Correct!Wrong!
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:
