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10 Steps to Clinical Study Startup: Step 9 – Site Initiation Visits

by Jae Chung

The final step in the study startup process is the Site Initiation Visit (SIV).

10 Steps to Clinical Study Startup: Step 9 - Site Initiation Visits

There may be situations or company policies, which allow the collection of final documents at the time of SIV, however core regulatory documents must be collected prior to the release of Investigational Product (IP) to the site (IRB approval, CTA, FDF, CV and medical license of the PI).

The purpose of the SIV is to provide training and ensure understanding of the protocol and Good Clinical Practice (GCP) requirements to the PI and their staff on all aspects of the protocol. It is mandatory for the PI, Sub-Investigator and coordinator to attend. Where an investigator meeting is held this can substitute for a majority of the training needs of the SIV, however according to the sponsor or CRO SOPs a site visit may still be required. No patient enrollment or protocol specific activities can be completed until the SIV has been completed.

During the SIV sponsor representatives such as the monitor, and medical lead will share data, review the on site study binder, provide site staff from all sites with a full and complete understanding of the protocol and their individual responsibilities. Additional team member from the sponsor might include study managers, medical directors and data managers. Additional site staff may include pharmacists, regulatory coordinators, imaging personnel, etc.

The impact of technology and remote monitoring on the future of SIV and Investigator meetings

Many argue that in-person meetings with physicians provide a platform for outcomes otherwise unattainable online and by phone. But, even in this relationship-intense profession, vendors and clients across all industries are meeting face-toface with far less frequency than even a few years ago. Time equals money, with obvious efficiencies generated via web and telecommunications technologies. Time and availability of site staff is restricted and concentrated on patient care, which leaves little time for operational meetings, which can be conducted in a virtual arena. However, the core outcome must continue to be focused on site knowledge and on the execution of the trial otherwise we will see a significant increase in sites failing to meet the goal of patient recruitment.

Terri Hinkley
Academy of Medical-Surgical Nurses (AMSN) and Medical Surgical Nursing Certification Board (MSNCB)
"The site initiation visit (SIV) is the opportunity for sites and sponsors/CROs to discuss the study in detail as well as for the sponsor/CRO to provide any study-specific instructions/training to ensure site staff understand the study protocol and other study plans (i.e., timelines, monitoring format, data entry guidelines, randomization procedures, etc.) and have the tools/information needed to effectively conduct the study."

10 Steps in Clinical Study Startup

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