The statement should include the name of the product being studied, all of the active ingredients, what the product is expected to do, and why the study is being done. The IRB/IEC should make sure that the proposed protocol and/or other document(s) adequately address relevant ethical concerns and meet applicable regulatory requirements for non-therapeutic trials that are carried out with the consent of the subject's legally acceptable representative. The training we offer will provide you with everything you need to know about GCP certification and more. Other medications that are allowed or not allowed during the course of the study must also be listed. List of TransCelerate Mutually Recognized GCP Training CITI Program provides GCP courses that meet the minimum criteria for ICH GCP Investigator Site The host must have written procedures that contain directions for the investigator/institution to follow for storing and handling investigational product(s) for your trial and documentation. If the trial is blinded, the investigator should promptly document and explain to sponsor any early unblinding of investigational product(s). ICH GCP guidelines for clinical data management. The monitor should also make sure that visits, tests, and other activities are properly documented. The Subject Identification Code is a number that is given to each person in a study. The IRB/IEC should review the investigator's qualifications for the proposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests. Click this link to demo our ICH GCP training free online here! To review them more effectively combine any two cards together if they both pertain to something related in theme (examples: "Committee" & Implementation). When people do audits as part of quality assurance, they should think about the purpose of the audit. When ready to recertify, even prior to the expiration of the current certificate, click on the "Recertify" button. These documents are essential in helping us evaluate a study and its results. Good Clinical Practice (GCP) | CITI Program
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