[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, 00:31:14 / 00:42:40