![]() ![]() The sponsor should determine the appropriate extent and nature of monitoring. (c) Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and the applicable regulatory requirement(s).ĥ.18.3 Extent and Nature of Monitoring The sponsor should ensure that the trials are adequately monitored. A monitor’s qualifications should be documented. (b) Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. (a) Monitors should be appointed by the sponsor. (c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).ĥ.18.2 Selection and Qualifications of Monitors (b) The reported trial data are accurate, complete, and verifiable from source documents. (a) The rights and well-being of human subjects are protected. The purposes of trial monitoring are to verify that: It contains the E6(R2) Addenda, and provides an overview of the scope of, requirements to clinical trial monitoring process, as well as responsibilities of all participants. Current section refers to the item 5.18 Monitoring of the INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2).
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