Completing and Signing Case Report Forms Sample Clauses

Completing and Signing Case Report Forms. Each investigator must keep a separate patient identification list showing code numbers, names, and dates of birth to allow unambiguous identification of each patient included in the study. A note will be made in the medical records that the patient is participating in a clinical study. All required data will be recorded on the CRF by study center personnel according to the data entry guidelines provided by ImmuPharma or its designee. All CRFs must be kept in good order and updated so they always reflect the latest observations on the patients participating in the study. When paper CRFs are used, they will be completed legibly in black ink, with reasons given for missing data. Any corrections to the data will be made in a manner that does not obscure the original entry and will be dated and initialed by the investigator or assigned designee. Each investigator will sign the statement on the last page of the CRF. When eCRFs are used, electronic signatures of the investigator (or designee) will be provided. Access to the eCRF for data entry and signature is controlled by user identification and password, which are provided ImmuPharma or its designee. Study center personnel will be trained, by ImmuPharma or a designated vendor, in the use of eCRFs and application of electronic signatures before the start of the study. Because it is extremely important to have proper data collection in a timely manner, the investigator shall complete the CRFs and provide them to the study monitor on an ongoing basis. When the study monitor requests additional data or clarification of data for the CRF, the request must be answered satisfactorily before the next monitoring visit.
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