Common use of Auditing and Monitoring Clause in Contracts

Auditing and Monitoring. 3.10.1 The Sponsor or its designee DCTD, NCI will be primarily responsible for monitoring clinical site Clinical Research Sites and for assuring the quality of all clinical data, unless otherwise stated in the Research Plan. Monitoring Auditing will comply with the DCTD guidelines as described on the CTEP website at: ▇▇▇▇://▇▇▇▇.▇▇▇▇.▇▇▇.▇▇▇/branches/ctmb/clinicalTrials/monitoring_coop_coop_ctsu. htm. FDA Good Clinical Practice (International Conference on Harmonisation (ICH) E6: “Good Clinical Practice: Consolidated Guidance; 62 Federal Register 25, 691 (1997)). The other Party may also perform quality assurance oversight. The monitor will communicate significant Protocol violations and submit documentation of monitoring outcomes on Protocol insufficiencies to the other Party in a timely manner. NCI clinical trials must be conducted in accordance with the FDA Good Clinical Practices (GCP). 3.10.2 Subject to the restrictions in Article 8 concerning IPI, and with reasonable advance notice and at reasonable times, ICD will permit seek permission for Collaborator or its designee(s) to access Clinical Research Sites toclinical site(s) to monitor audit the conduct of the research at times convenient to Clinical Research Sites, and to obtain updates on ongoing clinical trials. Collaborator may also make arrangements with ICD as well as to audit source documents containing Raw Data, at the completion of a Protocol and at Collaborator’s expense, to the extent necessary to verify compliance with FDA Good Clinical Practice and the Protocol(s).