CRA Training Series Vol. 3 - Conducting the Pre-Study Visit 2013

  • ID: 2567673
  • Book
  • Cambridge Healthtech Institute
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Pre-study visits (PSVs), which are also called Site Selection Visits (SSVs), are conducted at a potential study site to introduce the prospective investigator to the study protocol and to familiarize the staff with regulatory obligations and sponsor procedures. In addition, the visit provides an occasion for you to assess the investigator's interest in and ability to carry out the study. This includes determining whether the potential investigator has the time, facilities, equipment, access to subjects, and staff necessary to conduct the study.

- This manual provides guidance on how to conduct a prestudy visit. Specifically, the manual addresses the following:

- Shows how to schedule the meeting and how to prepare a meeting agenda.

- Suggests budget negotiation techniques

- Details the necessary discussions with site staff and investigator — the drug, protocol, access to source documents, case report forms (CRFs), and regulatory and sponsor obligations.

- Describes site assessment criteria.

- Presents selection recommendation procedures and documentation.
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Publications in this 7 volume set include:

Volume 1-An Overview of Drug Development
Volume 2-Identifying and Screening Investigators
Volume 3-Conducting the Pre-study Visit
Volume 4-Conducting the Study Initiation Visits
Volume 5-Conducting Routine Monitoring Visits
Volume 6-The CRA's Reference for Adverse Events
Volume 7-Test Your Knowledge
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