Common use of Auditing and Monitoring Clause in Contracts

Auditing and Monitoring. 3.10.1 DCTD, NCI will be primarily responsible for monitoring Clinical Research Sites and for assuring the quality of all clinical data, unless otherwise stated in the Research Plan. Auditing will comply with the DCTD guidelines as described on the CTEP website at: xxxx://xxxx.xxxx.xxx.xxx/branches/ctmb/clinicalTrials/monitoring.htm. 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, IC will permit Collaborator or its designee(s) access to Clinical Research Sites to audit the conduct of the research and to obtain updates on ongoing clinical trials at times convenient to Clinical Research Sites. Collaborator may also make arrangements with IC to audit Raw Data and source documents, 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).

Auditing and Monitoring. 3.10.1 DCTD, NCI will be primarily responsible for monitoring Clinical Research Sites and for assuring the quality of all clinical data, unless otherwise stated in the Research Plan. Auditing will comply with the DCTD guidelines as described on the CTEP website at: xxxx://xxxx.xxxx.xxx.xxx/branches/ctmb/clinicalTrials/monitoring.htm. xxxx://xxxx.xxxxxx.xxx/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm 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, IC will permit Collaborator or its designee(s) access to Clinical Research Sites to audit the conduct of the research and to obtain updates on ongoing clinical trials at times convenient to Clinical Research Sites. Collaborator may also make arrangements with IC to audit Raw Data and source documents, 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).

Auditing and Monitoring. 3.10.1 DCTD, NCI will be primarily responsible for monitoring Clinical Research Sites and for assuring the quality of all clinical data, unless otherwise stated in the Research Plan. Auditing will comply with the DCTD guidelines as described on the CTEP website at: xxxx://xxxx.xxxx.xxx.xxx/branches/ctmb/clinicalTrials/monitoring.htmhttp://ctep.xxxxxx.xxx/xxxxxxxx/xxxx/clinicalTrials/monitoring.htm. NCI clinical trials must be conducted in accordance with the FDA Good Clinical Practices promulgated by the FDA (“FDA GCP”). 3.10.2 Subject to the restrictions in Article 8 Paragraph 8.10 concerning IPI, and with reasonable advance notice and at reasonable times, IC will permit seek permission for Collaborator or its designee(s) to access to Clinical Research Sites to audit the conduct of the research at times convenient to Clinical Research Sites, and to obtain updates on ongoing clinical trials at times convenient to Clinical Research Sitestrials. Collaborator may also make arrangements with IC to audit Raw Data and source documents, at the completion of a Protocol and at Collaborator’s expense, to the extent necessary to verify compliance with FDA Good Clinical Practice GCP and the Protocol(s).