Tips when Entering Basic Results:
- The Enrollment # in the protocol section conflicts with the # of participants Started in the Participant Flow module
- The Arm/Group Description should be used to provide additional details about the interventions administered *(e.g., dosage, dosage form, frequency of administration) or groups evaluated.
- Expand all acronyms and abbreviations the first time used (and include acronym in parentheses).
Use “Spelling” feature
- Provide a brief but explicit summary of the criteria used for Outcome Measure/Assessment of progression/progressive disease
- # of Participants analyzed is not consistent with numbers provided in any of the rows in the Participant Flow Module
- The Outcome Measure should be specific and measurable by the units of measure provided
- Measure Title/Description (# of AEs) and Unit of Measure (# of Participants with AEs) are inconsistent
- The time-frame provided is not specific.
- Previous comments have not been addressed.
- Provide brief but informative Arm/Group titles