Which section addresses the common practice regarding prorated payment for subjects?

Which section addresses the common practice regarding prorated payment for subjects?

• A. ICH E6 Section 3.1.8
• B. ICH E6 Section 4.8.10(k)
• C. FDA Information Sheet
• D. ICH E6 Section 4.8.10(h)

Answer: (B)

The correct choice points to ICH E6 Section 4.8.10(k), which establishes guidelines regarding financial arrangements for trial subjects. This specific section addresses the practice of prorated payment for subjects who withdraw from a clinical trial. It emphasizes that when subjects do not complete the study, the payments they receive should correspond to the duration of their participation. This practice is important as it fosters ethical principles, ensuring that participants are compensated fairly for the time and effort they contributed to the study, even if they do not complete all aspects of the trial. It also serves to encourage participation by clarifying that subjects will not be financially penalized for their decision to leave the study early for any valid reason, thus respecting their autonomy and well-being. The other sections and documents referenced in the question do not specifically cover prorated payments in the context of subject withdrawal, making this option the most relevant for the inquiry regarding common practice in this area.

The correct choice points to ICH E6 Section 4.8.10(k), which establishes guidelines regarding financial arrangements for trial subjects. This specific section addresses the practice of prorated payment for subjects who withdraw from a clinical trial. It emphasizes that when subjects do not complete the study, the payments they receive should correspond to the duration of their participation.

This practice is important as it fosters ethical principles, ensuring that participants are compensated fairly for the time and effort they contributed to the study, even if they do not complete all aspects of the trial. It also serves to encourage participation by clarifying that subjects will not be financially penalized for their decision to leave the study early for any valid reason, thus respecting their autonomy and well-being.

The other sections and documents referenced in the question do not specifically cover prorated payments in the context of subject withdrawal, making this option the most relevant for the inquiry regarding common practice in this area.