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Difficulty: MediumDiscrepancy and Conflict Resolution Between Sources

The following three sources provide details regarding a Phase II clinical trial for a new therapeutic candidate:

Tab 1: Clinical Trial Protocol (Section 3.2)
Subjects in Arm A are scheduled to receive a daily dose of 50 mg50\text{ mg} of Active Drug X for 14 consecutive days14\text{ consecutive days}, followed immediately by a 7-day7\text{-day} washout period during which 0 mg0\text{ mg} of medication is administered. Subjects in Arm B receive a matching placebo daily for 21 consecutive days21\text{ consecutive days}.

Tab 2: Central Pharmacy Dispensing Log
During the 21-day trial window, the central pharmacy logged a total cumulative dosage of 700 mg700\text{ mg} of Active Drug X dispensed per subject in Arm A, and 0 mg0\text{ mg} dispensed per subject in Arm B.

Tab 3: Independent Auditor Compliance Report
The compliance audit reveals that subjects in Arm A logged active pill ingestion on each of the 21 days21\text{ days} of the trial window, recording no days with zero medication intake.

Which of the following statements, if true, would help explain or resolve the apparent discrepancy between the protocol specification, the pharmacy dispensing logs, and the auditor's compliance report? Select all that apply.

  1. Arm A subjects ingested a reduced daily dose of approximately 33.3 mg33.3\text{ mg} per day evenly over all 21 days rather than 50 mg50\text{ mg} per day for 14 days.Answer
  2. B
    Subjects in Arm A received 21 daily tablets containing 50 mg50\text{ mg} of Active Drug X each.
  3. The central pharmacy pre-packaged the 700 mg700\text{ mg} total allocation into 21 lower-dose daily capsules instead of 14 standard-dose capsules.Answer
  4. D
    The 7-day washout period was mistakenly enforced during the first 7 days of the trial rather than the final 7 days.
  5. E
    Arm B subjects mistakenly received the 50 mg50\text{ mg} daily dose intended for Arm A during the washout period.

Answer

The discrepancy is resolved by options stating that subjects ingested approximately 33.3 mg per day across all 21 days, or that the pharmacy pre-packaged the 700 mg allocation into 21 lower-dose daily capsules.
The correct options present scenarios where the total active drug allocation of 700 mg (from the pharmacy logs) is spread across all 21 trial days (from the compliance audit), resulting in a lower daily dosage of approximately 33.3 mg per day. This reconciles the 21 active ingestion days with the 700 mg total quantity dispensed.

Step-by-Step Solution

1
Identify the conflict between the sources.
Tab 1 prescribes 50 mg/day×14 days=700 mg50\text{ mg/day} \times 14\text{ days} = 700\text{ mg} plus a 7-day washout (0 mg/day). Tab 2 confirms a total of 700 mg700\text{ mg} dispensed for Arm A. Tab 3 shows active ingestion on all 21 days (0 washout days).
To resolve the conflict, any valid hypothesis must account for 21 active days of ingestion while keeping the total active drug amount at 700 mg700\text{ mg}.
2
Evaluate hypotheses regarding daily dose re-apportionment.
Dividing 700 mg700\text{ mg} by 21 days yields 70021=33.33 mg/day\frac{700}{21} = 33.33\text{ mg/day}.
If subjects took ≈33.3 mg\approx 33.3\text{ mg} per day for 21 days, or if the pharmacy packaged 700 mg700\text{ mg} into 21 daily capsules, both Tab 2 (700 mg700\text{ mg} total) and Tab 3 (21 active days) are satisfied.

Key Concept

Discrepancy Resolution across Multi-Source Documents
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Topics

Discrepancy and Conflict Resolution Between Sources

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