A pre-study visit is a site evaluation that is conducted prior to the initiation of a clinical trial. It is typically performed by a representative from the sponsor or the CRO and is designed to assess the site’s readiness and capability to conduct the study. The purpose of the this visit is to ensure that the site meets the regulatory and ethical requirements for conducting clinical trials and that the site is capable of conducting the study in a manner that is consistent with the protocol and good clinical practices (GCP).
During the pre-study visit, the following activities are typically performed:
- Review of regulatory documentation: The visit team will review the site’s regulatory documentation, including the institutional review board (IRB) or ethics committee (EC) approval and informed consent documents.
- Site facilities and equipment: The visit team will evaluate the site’s facilities, equipment, and supplies to ensure that they are suitable for conducting the study and that they meet the necessary regulatory requirements.
- Study personnel: The visit team will meet with the study personnel, including the principal investigator, study coordinators, and other staff, to discuss their roles and responsibilities and to assess their training and competence.
- Patient recruitment: The visit team will discuss the site’s plans for patient recruitment and enrollment, including the methods that will be used to identify and screen potential participants.
- Data management: The pre-study visit team will review the site’s data management processes and systems to ensure that they are suitable for collecting, storing, and reporting the trial data.
- Study conduct: The pre-study visit team will review the study protocol and procedures to ensure that the site is capable of conducting the study in a manner that is consistent with the protocol and GCP.
The pre-study visit is an important step in the clinical trial process and helps to ensure that the study is conducted in a manner that is compliant with the regulatory and ethical requirements and that the results of the study are reliable and of high quality.
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