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: ▇▇▇▇://▇▇▇▇.▇▇▇▇▇▇.▇▇▇/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 any applicable restrictions of NCI and the relevant Data Safety Monitoring Board, and with reasonable advance notice and at reasonable times, NCI will permit Collaborator or its designee(s) access to Clinical Research Sites to review the conduct of the research and to obtain updates on ongoing clinical trials at times convenient to Clinical Research Sites. Randomized phase 2 and phase 3 studies are conducted under the oversight of a DSMB and Collaborator will not have access to the Clinical Research Sites to audit during the conduct of the study, except under exceptional circumstances. Collaborator may also make arrangements with NCI to audit Raw Data and source documents, at the completion of the Protocol primary end point (or sooner, in exceptional or justified circumstances as agreed by the Parties prior to such completion) and at Collaborator’s expense, to the extent necessary to verify compliance with FDA Good Clinical Practice and the Protocol. DCTD will provide reasonable assistance to Collaborator to access additional data during the course of clinical study if appropriate and approved by the Data Safety Monitoring Board if there is one, or at the conclusion of the clinical study, for purposes of supporting Collaborator’s regulatory submissions related to the Investigational Agent, in the United States and abroad. Collaborator will be responsible for the costs associated with such access to additional data. Access and use of such additional data will be consistent with the restrictions in Article 8.

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 and monitoring will comply with the DCTD guidelines as described on the CTEP website at: ▇▇▇▇://▇▇▇▇.▇▇▇▇▇▇.▇▇▇/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 Section 8.10 concerning IPI IPI, ISI and any applicable restrictions of NCI and and/or the relevant Data Safety Monitoring Board, and with reasonable advance notice and at reasonable times, NCI will permit Collaborator or its designee(s) access to Clinical Research Sites to review audit Raw Data and source documents following the conduct completion of the research and to obtain updates on ongoing clinical trials Protocol at times convenient to Clinical Research Sites. For Randomized phase 2 and phase 3 studies regardless of whether they are conducted under the oversight of a DSMB and DSMB, the Collaborator will not have access to the Clinical Research Sites to audit during until data release has been approved by NCI and by the conduct of the study, except under exceptional circumstancesDSMB where applicable. Collaborator may also make arrangements with NCI to audit Raw Data and source documents, at the completion of the Protocol primary end point (or sooner, in exceptional or justified circumstances as agreed by the Parties prior to such completion) and at Collaborator’s expense, to the extent necessary to verify compliance with FDA Good Clinical Practice and the Protocol. DCTD will provide reasonable assistance to Collaborator to access for accessing additional data during that remains at the course of clinical study if appropriate and approved by the Data Safety Monitoring Board if there is one, or Clinical Research Sites at the conclusion of the clinical study, for purposes of supporting Collaborator’s regulatory submissions related to the Investigational Agent, in the United States and abroad. Collaborator will be responsible for the costs associated with such access to additional data. Access and use of such additional data will be consistent with the restrictions in Article 8.