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Request an agenda from the Monitor or create one for the SIV, if needed. If needed, provide the Monitor with directions and assistance identifying nearby accommodations. Assure personnel are familiar with sponsor-provided study materials (e.g.: protocol, Investigator Brochure, CRFs, etc.) in advance of visit.
Clinical trials that get off to a good start are more likely to be successful trials. The study startup phase is where this happens, and includes such activities as; investigator selection, regulatory and ethics submissions, site training and ends with the site initiation visits.
Prior to the site initiation visit, the sites clinical research study team should: Familiarize themselves with the protocol and consent documents; Finalize the case report form and data collection process; and. Prepare standard operating procedures for the clinical research study.
Interim Monitoring Visits (IMVs) will be conducted to confirm participants rights are being protected; the study is being conducted ing to the protocol and applicable regulations, including GCP; confirm accurate reporting of participant safety data and study endpoints.
The SIV serves the purpose of verifying that the site is prepared to commence the study and enroll participants, including ensuring that the site staff has access to all necessary study systems and supplies.
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The length of an initiation visit may vary ing to the complexity of each study, but a typical initiation visit lasts about 7 hours. Not all parts of the visit require attendance by all staff.
Preparing for a periodic monitoring visit: Identify a quiet place for the monitor to work and ensure access to a copy machine, phone, water fountain, and restroom. Complete all necessary CRFs. Confirm that Serious Adverse Event (SAE) forms have been submitted and are available for review.
Startup phase consists of activities like CRF creation and Designing, Database designing and Testing, Edit checks preparation and User Acceptance Testing (UAT) along with document preparation such as Data Management Plan, CRF Completion Guidelines, Data Entry Guidelines and Data Validation plan.

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