Table I.
Frequency of error types in submitted data.
Error | n |
---|---|
Date of last dose prior to SAE is after date of onset. | 16 (32.7%) |
Date of onset for adverse event is before patient was randomized. | 12 (24.5%) |
End date for concomitant medication is before medication start date. | 4 (8.2%) |
Date of onset for adverse event is after date of resolution. | 4 (8.2%) |
Assessment of Eligibility indicates that FVC is > = 60% of predicted (Q3), yet the Forced Vital Capacity form (Q1–4) contradicts this. | 4 (8.2%) |
Date of data collection is after the date that the eCRF data was posted. | 3 (6.1%) |
Assessment of Eligibility indicates that disease duration is < 5 years (Q5), yet the neuromuscular exam form (date of onset) contradicts this. | 3 (6.1%) |
Start date for condition in medical history is after date of end date. | 2 (4.1%) |
Start date for condition in medical history is after patient was randomized. | 1 (2.0%) |