[00:28:39] Case Report Form (CRF)
[00:29:30] Data Correction - Proper Procedures for CRFs/Source Documents
[00:30:37] Avoid Signature Irregularities
[00:31:06] Common CRF Errors
[00:32:33] FDA 21 CFR 11: Electronic Records/Electronic Signatures (ERES)
[00:35:11] FDA 21 CFR Part 11
completing case report forms. The first is missing data.
This may be the result of: Incomplete forms, or blank
fields, Unreported data, such as previous history,
concurrent illnesses, concomitant treatments or adverse
events, Forms not received/lost, or Corrections on source
documents that are not entered on CRFs The second
common source of errors is poorly completed forms.
These errors occur due to: Illegible data,
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