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. Author manuscript; available in PMC: 2018 Feb 13.
Published in final edited form as: Amyotroph Lateral Scler. 2009 Oct-Dec;10(5-6):374–377. doi: 10.3109/17482960802378998

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%)