Common use of Study Monitoring Clause in Contracts

Study Monitoring. Sponsor or its designee will monitor the conduct of the trial on a regular basis throughout the duration of the study, according to the monitoring plan and in compliance with ICH-GCP E6 (R2). Monitoring of the study will serve to ensure: (a) The rights and well-being of human subjects are protected; (b) The reported trial data are accurate, complete, and verifiable from source documentation; and (c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s). The study monitor will train site personnel on the conduct of the trial. The monitor will assess the trial site’s compliance with the protocol and will periodically review and verify a sample of the patient data recorded on CRFs against source documentation. The study monitor will also review documents that provide evidence of the proper consent and eligibility of enrolled patients, the compliant conduct of study procedures, the administration and disposition of investigational product(s), the reporting of serious adverse events and adverse reactions, and the continued maintenance of trial records. The Investigator will allocate adequate time to support such monitoring activities. The Investigator will also ensure that the monitor is given reasonable remote and/or on-site access to study-related documents, source documents (regardless of media) and study-related facilities (eg, investigational pharmacy, etc). Queries may be raised if any datum is unclear or contradictory. The Investigator and site personnel must address all queries in a timely manner.

Study Monitoring. Sponsor or its designee will monitor the conduct of the trial on a regular basis throughout the duration of the study, according to the monitoring plan and in compliance with ICH-GCP E6 (R2E6(R2). Monitoring of the study will serve to ensure: (a) The rights and well-being of human subjects are protected; (b) The reported trial data are accurate, complete, and verifiable from source documentation; and (c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s). The study monitor will train site personnel on the conduct of the trial. The monitor will assess the trial site’s compliance with the protocol and will periodically review and verify a sample of the patient data recorded on CRFs against source documentation. The study monitor will also review documents that provide evidence of the proper consent and eligibility of enrolled patients, the compliant conduct of study procedures, the administration and disposition of investigational product(s), the reporting of serious adverse events and adverse reactions, and the continued maintenance of trial records. The Investigator will allocate adequate time to support such monitoring activities. The Investigator will also ensure that the monitor is given reasonable remote and/or on-site access to study-related documents, source documents (regardless of media) and study-related facilities (eg, investigational pharmacy, etc). Queries may be raised if any datum is unclear or contradictory. The Investigator and site personnel must address all queries in a timely manner.