DATA ARCHIVAL. 7.1. After completion of the Trial, Sponsor will provide the Investigator with a CD-ROM containing the entered and signed data for all Trial Participants of his/her site, including the audit trail / discrepancy details. Investigator will confirm the receipt, as well as the verification of completeness and correctness of the data contained on the CD-ROM to Sponsor. Investigator will archive the CD-ROM as part of the ISF file, to be readily available for audit and inspection purposes.
Appears in 5 contracts
Sources: Clinical Trial Agreement, Individual Clinical Trial Agreement, Individual Clinical Trial Agreement
DATA ARCHIVAL. 7.1. After completion of the Trial, Sponsor will provide the Investigator with a CD-CD- ROM containing the entered and signed data for all Trial Participants of his/her site, including the audit trail / discrepancy details. Investigator will confirm the receipt, as well as the verification of completeness and correctness of the data contained on the CD-ROM to Sponsor. Investigator will archive the CD-ROM as part of the ISF file, to be readily available for audit and inspection purposes.
Appears in 2 contracts
DATA ARCHIVAL. 7.1. After completion of the Trial, Sponsor will provide the Investigator with a CD-ROM containing the entered and signed data for all Trial Participants of his/her site, including the audit trail / discrepancy details. Investigator will confirm the receipt, as well as the verification of completeness and correctness of the data contained on the CD-ROM to Sponsor. Investigator will archive the CD-ROM as part of the ISF file, to be readily available for audit and inspection purposes.correctness
Appears in 1 contract
Sources: Clinical Trial Agreement
DATA ARCHIVAL. 7.1. After completion of the Trial, Sponsor will provide the Investigator with a CD-ROM containing the entered and signed data for all Trial Participants of his/her site, including the audit trail / discrepancy details. Investigator will confirm the receipt, as well as the verification of completeness and correctness of the data contained on the CD-ROM to Sponsor. Investigator will archive the CD-CD- ROM as part of the ISF file, to be readily available for audit and inspection purposes.
Appears in 1 contract
Sources: Clinical Trial Agreement