Common Errors

Tips when Entering Basic Results:

    1. The Enrollment # in the protocol section conflicts with the # of participants Started in the Participant Flow module
    2. 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.
    3. Expand all acronyms and abbreviations the first time used (and include acronym in parentheses).
      Use “Spelling” feature
    4. Provide a brief but explicit summary of the criteria used for Outcome Measure/Assessment of progression/progressive disease
    5. # of Participants analyzed is not consistent with numbers provided in any of the rows in the Participant Flow Module
    6. The Outcome Measure should be specific and measurable by the units of measure provided
    7. Measure Title/Description (# of AEs) and Unit of Measure (# of Participants with AEs) are inconsistent
    8. The time-frame provided is not specific.
    9. Previous comments have not been addressed.
    10. Provide brief but informative Arm/Group titles