Template Date: To: From: Welcome Monitor Memo Clinical Research Monitor/Sponsor/CRO Coordinator/Administrator For PI Division / Department Re: Monitoring of (name of study) We want to ensure that this will be a mutually satisfying working relationship. The following summarizes what you can expect from your Coordinator and what he/she expects from you: Site Coordinator Responsibilities Prior to your scheduled visit: The Site Coordinator will have prepared case report forms and printed the corresponding medical records for your review. The Site Coordinator will have notified the Regulatory Coordinator (if applicable) of your visit, and arranged a time for you to review the regulatory files. The coordinator will have arranged for you to meet with the Principal Investigator and/or Pharmacy if it was planned for that visit. On the day of the visit: The Coordinator will orient you with WCMC medical records to facilitate source verification The Coordinator will be available during your visit to answer questions and assist in locating the proper documents. At the end of your visit: You and the Coordinator should meet to go over your findings. You and the Coordinator will complete the Monitoring Visit Summary Form (with the Regulatory Coordinator, if applicable). Monitor Responsibilities General: We anticipate monitoring visits to be conducted at intervals of _______. If you feel that there is a need for more frequent visits, please discuss this with the coordinator. We require at least 2 weeks notice in planning a monitoring visit in order to properly prepare (i.e. case report forms, visits with the pharmacy and/or principal investigator). Due to space constraints, if for any reason, you need to bring additional personnel with you, arrangements must be made at least 2 weeks in advance. If you arrive with more people than expected, we cannot guarantee available monitoring space. It is expected that there will be routine monitoring letters sent to the Principal Investigator throughout the course of the study. We ask that the Coordinator and This document is meant to aide in the process of conducting a clinical trial and its usage is not required, for it is not part of the formal procedure conducted at WCMC. Regulatory Coordinator be copied on all correspondence to the Principal Investigator, which relates to data management. During your visit: Our office hours are 9am-5pm, Monday through Friday. No monitoring is allowed without a staff member present. If you anticipate needing to work outside of the regular operating hours arrangements must be made in advance with the coordinator. A copy machine will be available for you to make copies of any regulatory documents needed for your files. Copying of participant records is not permitted. Writing in a participant’s medical record or in a subject’s CRF is not allowed. Participant records are never to be removed from the premises. At the end of the day all case report forms, binders and/or paperwork should be returned to the Coordinator. Prior to the completion of your visit: Please complete the Monitoring Visit Summary Form and review it with the Coordinator and Principal Investigator. If you identify any issues they should be addressed at this time. A copy of this form will be provided for your files and stored in the regulatory binder. (We) will strive to make your visits as productive as possible. If you feel there are issues that are not being addressed to your satisfaction please contact Site Administrator/PI at ____________ to arrange an appointment. We welcome your comments and suggestions. _____________________________ Coordinator _______________________________ Principal Investigator We would like to express that confidentiality of patient information is imperative and ask for your cooperation in adhering to the above guidelines. I have received and read the welcome memo outlining the monitoring policies and procedures for Dr. ____________s office. ______________________________ Monitor Signature _____/_____/_____ Date This document is meant to aide in the process of conducting a clinical trial and its usage is not required, for it is not part of the formal procedure conducted at WCMC.