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:
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’s 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
