From the Guidelines
The correct answer is D. Procedures for accounting for missing, unused, and false data. The Treatment of Subjects section of a research protocol typically focuses on the actual interventions and treatments that participants will receive during the study. This section should include:
- Medication names (option A)
- Dosing schedules (option B)
- Procedures for assessing treatment adherence (option C), as these all directly relate to how subjects will be treated during the research, as outlined in the SPIRIT 2013 statement 1. However, procedures for accounting for missing, unused, and false data are typically found in the Data Management or Statistical Analysis sections of a protocol, as they relate to how data will be handled after collection rather than how subjects will be treated. These data handling procedures are important for maintaining data integrity and ensuring valid results, but they are not part of the actual treatment administration to research participants, and are instead addressed in sections such as 18b and 20c of the SPIRIT 2013 statement 1. In Good Clinical Practice (GCP), it's essential to understand where different elements belong in a research protocol to ensure comprehensive and properly organized documentation.
From the Research
Treatment of Subjects Section
The Treatment of Subjects section in a research protocol typically includes information about the medications, dosing schedules, and procedures for assessing treatment adherence.
- The names of all medications to be administered are usually included in this section, as well as the dosing schedules of all medications to be administered.
- Procedures for assessing treatment adherence are also typically included.
- However, procedures for accounting for missing, unused, and false data are generally discussed in the data management or statistical analysis sections of the protocol, rather than the Treatment of Subjects section.
Relevant Information
Based on the provided studies, it appears that accounting for missing data is an important aspect of research, but it is not typically included in the Treatment of Subjects section of a research protocol 2, 3, 4, 5.
- These studies discuss various methods for handling missing data, including multiple imputation, inverse probability weighting, and double sampling 2, 3, 4.
- However, they do not suggest that these methods should be included in the Treatment of Subjects section of a research protocol.
Correct Option
Therefore, the correct option is: D. Procedures for accounting for missing, unused, and false data. This option is not typically included in the Treatment of Subjects section of a research protocol, according to the provided studies 2, 3, 4, 5.