Monitoring and Data Collection. CMT may monitor the Study and receive any subject-level Study data, excluding the identity of any patients involved with the Study. During and for a period of at least two years after the completion of the Study, CMT shall promptly report to the Investigator any information that could directly affect the health or safety of past or current Study subjects or influence the conduct of the study, including but not limited to the Study results and information in site monitoring reports and data safety monitoring committee reports as required by the Protocol. In each case, the Investigator and Institution shall be free to communicate these findings to each Study subject and the IRB.
Monitoring and Data Collection. California American Water shall implement a brine monitoring program (the “Agreed Monitoring Program”) as follows:
a. At least one year prior to the first discharge of the Project’s brine into the Sanctuary, California American Water shall install equipment required either to monitor the salinity levels in the seawater (“Salinity”) by measuring the specific conductivity of the monitored seawater at intervals of no more than 15 minutes or to perform any equivalent protocol required pursuant to either an Alternative Monitoring Program (as defined in Section 3.2 below) or a standard imposed pursuant to Section 4.1(a)(B) below (the “Monitoring Equipment”). California American Water shall install the Monitoring Equipment in at least four locations (the “Monitoring Locations”). Unless modified pursuant to Section 3.2 below, the Monitoring Locations shall be within 3 meters of the ocean floor in each of the following locations, which are depicted for illustrative purposes only on Exhibit A:
i. The Zone of Initial Dilution Location: 10 meters downslope of the outfall;
ii. The Compliance Point Location: 100 meters downslope of the outfall;
iii. The Far Field Location: 1000 meters downslope of the outfall, intended to measure far-field effects;
iv. The Reference Location: 1000 meters north of the outfall, and along the same elevation contour as the outfall, which is intended to measure conditions without the influence of the outfall.
b. Commencing at installation of the Monitoring Equipment and continuing throughout the life of the Project, California American Water shall operate and maintain the Monitoring Equipment in good working order, ensuring that it is collecting and recording data at intervals of no more than 15 minutes or is performing all data collection required under an Alternative Monitoring Program, as appropriate. California American Water shall replace and maintain the Monitoring Equipment as necessary to ensure such data collection.
c. Beginning on the Effective Date and continuing until the date that the Project begins to regularly provide customers with water from the desalination component of the Project (the “Project Commencement Date”), California American Water shall collect data on the Salinity, and any other brine constituent for which a standard is imposed pursuant to Section 4.1(a)(B) below, from each Monitoring Location no less than once each calendar month. Prior to the time the Monitoring Equipment is installed, data shall be collected ...
Monitoring and Data Collection. The key sponsor contact, monitors, auditors or regulatory inspectors are responsible for contacting and visiting the investigator for the purpose of inspecting the facilities and verifying source documents and records assuring that subject confidentially is respected. The monitor is responsible for source document verification of CRF data at regular intervals during the study. Protocol adherence, accuracy and consistency of study conduct and data collection with respect to local regulations will be confirmed. Monitors will have access to subject records as identified in Section 13. By signing the investigator agreement, the investigator agrees to cooperate with the monitor to address and resolve issues identified during monitoring visits. In accordance with ICH GCP and the audit plan, a site may be chosen for a site audit. A site audit would include, but is not limited to, an inspection of the facility (ies), review of subject and study related records, and compliance with protocol requirements as well as ICH GCP and applicable regulatory policies. All data will be collected in an electronic CRF system. All entries must be completed in English and concomitant medications should be identified by tradenames. For further details surrounding the completion of CRFs, refer to the CRF completion guidelines.
Monitoring and Data Collection. All community pharmacies participating in the scheme will be expected to participate in evaluation and monitoring activities as required. The pharmacy must allow the Commissioners internal and other nominated auditors access to all or any information relating to the Minor Ailment Scheme for the purposes of the audit.
Monitoring and Data Collection
