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Site initiation visit (siv): clinical trial basics, what is an siv in clinical research, siv definition: site initiation visit.

An SIV (clinical trial site initiation visit) is a preliminary inspection of the trial site by the sponsor before the enrollment and screening process begins at that site. It is generally conducted by a monitor or clinical research associate (CRA), who reviews all aspects of the trial with the site staff, including going through protocol documents and conducting any necessary staff training.[ 1 ],[ 2 ]

Also known as a study start-up visit, the sponsor can only request an SIV after the site has been selected and formal agreements such as the CTA have been signed.

What is the purpose of an SIV?

Clinical trial SIVs are necessary to ensure that all personnel of a given site who will be involved in the clinical trial, such as investigators and study staff, thoroughly understand the trial protocol and are trained appropriately so as to handle their role and responsibilities. Furthermore, the site initiation visit has the aim of ensuring the trial site is operationally ready, with working infrastructure, tools, and any study materials needed.[ 1 ]

Given the scope of the SIV, clinical trial sponsors should schedule this visit well before enrollment so that there is plenty of time to comprehensively inspect all relevant processes, and to conduct further training or rectify any issues, if necessary.

Can the SIV be conducted before IRB approval?

IRB approval is generally necessary before the SIV is carried out. Clinical trial sponsors should select sites that are compliant with all applicable regulatory requirements, and after the site receives IRB approval for the research, the sponsor can conduct the SIV.

SIV checklist for thorough site initiation visits

Given the importance of the SIV, clinical trial sponsors should make the most of this inspection visit by coming fully prepared with a detailed checklist of what is to be confirmed during the SIV.

Clinical trial sites might receive a copy of this checklist so they can ensure that all relevant staff are present for the visit. Specific tasks to include in the SIV checklist include the following:[ 1 ],[ 2 ],[ 3 ],[ 4 ]

• Discussing the clinical trial’s objectives with study staff
• Educating the research team on Good Clinical Practices
• Reviewing the operation schedule for the protocol
• Discussing the enrollment and screening process, including clarifying the inclusion and exclusion criteria
• Reviewing the informed consent documents and procedure
• Clarifying procedures for storing, dispensing, and managing the investigational product (IP)
• Checking inventory for all required medical supplies and equipment
• Ensuring secure access to all digital platforms, i.e., correct usernames and passwords
• Touring the clinical trial site to ensure facilities are in proper condition
• Reviewing and discussing all clinical trial documentation, such as forms, surveys, SOPs, etc.
• Reviewing the data management system and any other technological solutions forming part of the site’s or sponsor’s workflow
• Ensuring that site staff are up to date on training and understand how to maintain essential documentation
• Reviewing the site/trial budget financial protocols, including any processes related to compensating trial participants
• Verifying and testing reporting procedures possible adverse events
• Leaving room for an open discussion of any specific concerns that trial staff may have

This checklist provides basic guidelines only, and should be built upon and customized for each individual study according to risk areas and specific protocols.

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Site Monitor Visits

Study sites are monitored to ensure oversight of the clinical research study by the sponsor..

Regular site monitor visits can be broken down into four types: pre-study visits, initiation visits, periodic monitoring visits, and close-out visits.  Study sites may also be monitored or audited by the FDA, Clinical Research Organizations (CROs), IRBs and sponsors.  For more information on site audits by outside entities please visit the training documents on  Quality Management: Audits .

Pre-Study Visits

Pre-study visits (site selection visits or site qualification visits (SQVs)) are conducted to determine if the investigator and clinical site have the capability to conduct the study. During this visit, both an investigator and a study coordinator must be available. When applicable, pharmacy staff may also need to be available. The monitor will usually request a tour of the facility and time to discuss the basic fundamentals of the protocol and how that relates to the feasibility of recruiting potential participants.

Other topics of discussion during the pre-study visit include:

• Investigator responsibilities
• Qualifications of investigator or other site personnel
• Study objectives, protocol-required procedures, eligibility criteria, and patient recruitment
• IRB (e.g., informed consent requirements)
• Adverse event reporting, source documentation, and record retention
• Space requirements, availability of a secure area to store investigations drug or devices, availability of required equipment

Initiation Visits

A Site Initiation Visit (SIV) is when the research study team receives adequate training from the sponsor or CRO on the protocol. It is also the opportunity for the sponsor or CRO to ensure that the investigator fully understands his/her responsibilities (21 CFR 312 Subpart D). This visit usually occurs after the site has completed all regulatory requirements and has obtained IRB approval for the research study at their site. The initiation visit is the last step before the study site is activated for enrollment by the sponsor.

During study start-up, a sponsor may choose to hold an investigator meeting for a large number of sites in lieu of conducting many site initiation visits. If you are required to travel to an investigator meeting for a study, visit the Office of Sponsored Programs (OSP) for OSU’s travel policies.

Other topics of discussion during the site initiation visit include:

• Study overview, eligibility criteria, procedures, access to suitable patient population
• Lab manual, requirements for research sample processing and shipping
• Regulations and Good Clinical Practice (GCP) guidelines, informed consent requirements, IRB obligations, adverse event reporting, drug accountability
• Data forms review including Case Report Forms (CRFs)
• Regulatory documents and study file organization
• 21 CFR 312 Subpart D Responsibilities of Sponsors and Investigators
• OSP Travel  

Periodic Monitoring Visits

The sponsor and/or CRO will develop a monitor plan that includes the frequency and duration of periodic monitor visits. The focus of these visits is to evaluate the way the study is being conducted and to perform source document verification. These visits can occur every few weeks to once a year and can take less than one day up to several days at a time.  It is important to be familiar with the contract agreements, as they may contain the agreement as to the frequency and duration of site monitoring visits and the sponsor’s data entry expectations. The contract agreement should match what the sponsor and/or CRO creates in the site monitor plan.

At the beginning of the study, it should be determined where the monitor or monitors will work while they are on site. Ideally, the monitor should have their own workspace separate from the research study team. In addition, many monitors require internet access for their laptops. Instructions for OSUMC guest wireless can be found  here .

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
• Obtain medical records for the CRFs to be reviewed
• Organize study file documents for review
• Confirm that signed consent forms for all enrolled participants are available
• Schedule an appointment for the monitor to visit the pharmacy if needed
• Schedule time for the study coordinator to meet with the monitor towards the end of the visit to review findings
• Schedule time for the investigator to meet with the monitor towards the end of the visit to review findings

Close-Out Visits

When the research study has been completed at a site, a close-out visit occurs. This type of visit can take the form of an on-site visit or, in some cases, be conducted via a telephone call. Some close-out visits are also combined with a final periodic monitoring visit.

Action items during the close-out visit may include:

• Discuss timelines and strategies for the completion of outstanding case report forms and queries
• Return or destruction of study drug
• Collect outstanding patient data forms and study forms such as the screening and monitoring logs
• Perform a final review of the study file documents
• Discuss the plans for record retention
• Discuss ongoing investigator responsibilities

Liu, M.B. and Davis, K.; Chapter 6: Monitoring.  Lessons from a Horse Named Jim: a Clinical Trials Manual from the Duke Clinical Research Institute . Durham, NC: Duke Clinical Research Institute, 2001. Print.

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