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What to expect from your site qualification visit: last minute prep tips.

Site Qualification visits are an essential component of the clinical trials site selection process. This visit allows both you and the trial's Sponsor to learn more about each other and ascertain if the study is a good fit.‌ It is also your chance to show that you and your facility can support the many regulatory and performance requirements that each clinical study demands.

Do you know what to expect during your site visit? Learn more about how you can prepare with these easy tips:

Preparing for the Sponsor

Assessing the suitability of your staff and site is a top priority for Sponsors during a site visit. Sponsor representatives will review the qualifications and background of all participating physicians and staff at your clinical site. They will also assess whether you have sufficient training, time and resources to fulfill the clinical study's requirements.

Prepare for these reviews by:

Having updated and comprehensive CV's on hand for the Sponsor to review for key study personnel. It is important to emphasize any prior clinical trial work or publications. This can also include experience gained while in Residency training. Ensure that you also have copies of applicable medical licenses on hand for review during and following the site qualification visit.

Holding a group protocol review meeting with your staff prior to the site qualification visit. Be sure to include all study staff and discuss the protocol, IRB requirements, SOPs, and any required training in depth. Try to brainstorm any issues that may arise while trying to execute the protocol, as this can help generate points that may need clarification during the visit. Sponsors are looking for experienced, efficient staff members who are engaged and will make their study a priority.

Ensuring you have a recruitment strategy and enrollment target timeline ready ahead of time to share with the Sponsor. Sponsors want to know that you will be able to meet their recruitment goals, so it is key to show that you are prepared with a strategy and have contingency recruitment plans.

Preparing for the Site Qualification Facility Inspection

An important part of any site qualification visit involves inspecting available clinical and storage space. Clinical trials require dedicated areas for study administration, examinations, drug and data storage. Sponsors will assess whether you have the necessary equipment and space to execute their study requirements.

Be sure that all designated areas are used exclusively for their assigned purposes. Prior to inspection, ensure that all areas are clean and have only applicable items stored in the area.

Ensure all applicable laboratory and medical licenses are up to date prior to the start of the site qualification visit.

Check that your facility has met the necessary security requirements in regard to drug storage, data security and access.

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Clinical site qualification visits best practices.

Medha Datar

• March 12, 2023

Clinical site qualification visits are an essential step in ensuring that clinical trial sites are qualified to conduct a study. These visits allow sponsors and contract research organizations (CROs) to assess the suitability of potential sites and verify that they meet the study requirements.

Here are some best practices for conducting clinical site qualification visits:

• Prepare in advance

Preparation is critical to the success of a site qualification visit. Before the visit, review the study protocol, site-specific documents, and any other relevant study materials to understand the site’s capabilities and needs. This will help you prepare a list of questions and requirements that need to be addressed during the visit.

• Establish clear objectives

It is essential to establish clear objectives for the visit and communicate them to the site staff. Make sure they understand the purpose of the visit and what is expected of them. Clear communication will ensure that the visit runs smoothly and that the site staff is fully engaged in the process.

• Conduct a pre-visit assessment: 

Conduct a pre-visit assessment to gather information about the site’s history, experience, infrastructure, and staffing. This will help you identify any potential issues that need to be addressed during the visit.

• Plan the visit itinerary

It is crucial to plan the itinerary of the visit to ensure that all necessary areas are covered. Schedule time to meet with key staff members, review documentation and tour the site facilities. A well-planned itinerary will help ensure that the visit is efficient and that all relevant areas are evaluated.

• Conduct an opening meeting

Conduct an opening meeting to introduce the site staff to the study team and clarify the objectives of the visit. This meeting should include a review of the study protocol, site-specific documents, and any relevant study materials. The meeting is an opportunity to establish rapport with the site staff and to build a positive working relationship.

• Review documentation

Review the site’s regulatory and institutional review board (IRB) documentation to ensure that it is up to date and in compliance with local regulations. This includes reviewing the informed consent forms, investigator brochures, and other relevant documents. The review will help ensure that the site is qualified to conduct the study and that all regulatory requirements have been met.

• Assess facilities and equipment

Evaluate the site’s facilities and equipment to ensure that they meet the study requirements. This includes reviewing the storage, security, and access control measures in place for investigational products and study documents. The assessment will help ensure that the site is equipped to handle the study materials and that they are being stored and secured appropriately.

• Assess site personnel

Assess the qualifications and experience of the site personnel, including the principal investigator, sub-investigators, research coordinators, and study nurses. Verify that they have received appropriate training and are familiar with the study procedures. The assessment will help ensure that the site staff is qualified to conduct the study and that they have the necessary experience to manage the study requirements.

• Evaluate data management procedures

Evaluate the site’s data management procedures, including the use of electronic data capture (EDC) systems, source documentation, and quality control measures. The evaluation will help ensure that the site is equipped to manage the study data and that the data is being collected and managed accurately and securely.

• Conduct a closeout meeting

Conduct a closeout meeting to summarize the findings of the visit and provide feedback to the site staff. Clarify any deficiencies and outline the steps that need to be taken to address them. The meeting is an opportunity to ensure that the site staff understands the findings and to establish a plan of action to address any deficiencies.

Follow up with the site staff after the visit to ensure that any deficiencies have been addressed and that the site is ready to proceed with the study. Continue to monitor the site throughout the study to ensure that it is meeting the study requirements. Ongoing communication with the site staff is critical to the success of the study.

In conclusion, site qualification visits are an essential

By following these best practices, sponsors and CROs can conduct effective and efficient clinical site qualification visits that ensure the quality of the study data and the safety of the study participants.

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Pre-Study Preparation

The key decisions involved with the pre-study preparation of industry-sponsored clinical trials include the following:

Confirm Research Support Services/Facilities

Based on your final budget and contract, contact the supporting departments who will be involved with the trial to let them know you are ready to begin. This might include:

ITHS CLINICAL RESEARCH CENTER

ITHS RESEARCH COORDINATION CENTER

INVESTIGATIONAL DRUG SERVICE PHARMACY Harborview Medical Center (206) 744-5448 | [email protected] UW Medical Center (206) 598-6054 | [email protected] Website

UWMC LABORATORY MEDICINE Administration (206) 598-6131 |  [email protected]

RESEARCH TESTING SERVICE (206) 616-8979 |  [email protected]

UW DEPARTMENT OF PATHOLOGY NWBioSpecimen

UW DEPARTMENT OF RADIOLOGY RESEARCH PROGRAM

Site Initiation Visit

Many industry sponsors/Clinical Research Organizations conduct a Site Initiation Visit (SIV) to prepare and set up a research site, conduct protocol training, and ensure the Principal Investigator (PI) fully understands all trial responsibilities.  The visit usually occurs after the site has completed all regulatory requirements, including Institutional Review Board approval, but prior to recruiting participants.  The sponsor/Clinical Research Organization will want to meet with the PI and as many members of the research team as possible.  The sponsor/Clinical Research Organization may ask to meet with representatives from supporting departments (e.g., pharmacy, radiology, lab medicine).

Topics of discussion during the site initiation visit include:

• PI responsibilities
• PI and research team qualifications
• Study objectives, eligibility criteria, recruitment, and procedures
• Space requirements, availability of a secure area to store investigational drug or devices, availability of required equipment
• Lab manual, specimen processing, and shipping
• Regulations and Good Clinical Practice (GCP) guidelines, informed consent requirements, Institutional Review Board obligations, adverse event reporting, drug accountability, source documentation, and records retention (regulatory documents and study file organization)
• Data forms review (Case Report Forms, or CRFs), including electronic data entry

If it is a large multi-site trial, a sponsor/Clinical Research Organization may choose to hold an Investigator Meeting in lieu of conducting site initiation visits.  In this case, the meeting is held sometime after the Site Qualification Visit (link to Site Qualification Visit ) and prior to recruiting participants. The Investigator Meeting is usually only attended by the PI.  However, if the PI is unable to attend, the sponsor/Clinical Research Organization may allow a co-investigator or research coordinator to attend.  Travel to this meeting is coordinated and paid for by the sponsor/Clinical Research Organization.

Access to UW Electronic Medical Records

To use the University of Washington’s electronic medical record systems (ORCA and Epic) to identify eligible patients or capture clinical data about participants, you will need to request ORCA and Epic access for necessary research staff from User Access Administration .

If you have questions about ORCA access privileges or how to complete the form, contact: [email protected] .

If you access PHI for research purposes under an Institutional Review Board-approved HIPAA waiver, you must record and submit records of the dates and purposes of these disclosures to UW Medicine Compliance via the UW Medicine Disclosure Accounting online database.

UW MEDICINE COMPLIANCE (206) 543-3098 | [email protected] Accounting of Disclosures Use & Disclosure of Protected Health Information for Research Accounting of Disclosures of Protected Health Information

Pre-Screening to Identify Participants

To identify possible subjects for research, you may need to access Epic or ORCA to look at healthcare records. Even if you are involved in the clinical care of the possible subjects, you will need Institutional Review Board approval of a Waiver of HIPAA Authorization (and if the UW is the Institutional Review Board reviewing the project, a Waiver of Informed Consent and Confidentiality Agreement as well).

Members of your research team may need to complete Epic Training, which is described in the “Training/Credentialing” section below.

Clinical Research Billing for Research Procedures

There are complex federal and private payer rules that govern the conditions under which clinical services, items and tests associated with a research study can be billed to study sponsors, study subjects and/or their insurers. Research teams are required to use Epic to accurately bill for research procedures. Accurate research billing depends on planning and collaboration between the research team and a wide variety of individuals and offices before, during and after the study is initiated.

EPIC REVENUE CYCLE OPERATIONS EDUCATION [email protected] Research Billing Compliance Policies Research Participant Association in Epic Epic Billing Tools

Laboratory Medicine and Research Testing Services

If results of testing performed by University of Washington Lab Medicine will be part of data capture, you must maintain copies of lab normal ranges along with CLIA and CAP certifications.

Licenses & Accreditation

Lab Medicine is also the home department for Research Testing Services, which coordinates and provides research-related phlebotomy, CLIA-licensed testing, research-only testing, processing, and limited specimen storage.

UW LABORATORY MEDICINE Research Testing Service (206) 616‑8979 |  [email protected]

Research Instrument Validation and Calibration

Scientific Instruments supports more than 18,000 pieces of patient care, laboratory, and research equipment spread across the greater Seattle area including UW Medical Center, Harborview Medical Center, Northwest Hospital & Medical Center, Seattle Cancer Care Alliance, UW Physician’s Neighborhood Clinics and a variety of other University, state, federal and other publicly funded agencies.  Their records can be used to document compliance with TJC, CAP, CLEA, AABB, Food and Drug Administration, CMS, or other accrediting agencies’ requirements for equipment maintenance.

UW HEALTH SCIENCES SCIENTIFIC INSTRUMENTS Machine Shop (206) 616-5074 |  [email protected]

Arranging Compensation for Research Participants

Trials often offer compensation to research participants to encourage and appreciate the time and effort involved in participation.  Payments or travel/parking reimbursements to research subjects must be approved by the IRB as part of the research activities.  You may need to work with your department to identify specific procedures for compensation of research participants.

UW HUMAN SUBJECTS DIVISION (206) 543-0098 |  [email protected]

UW PROCUREMENT SERVICES (206) 543-4500 |  [email protected]

UW TRANSPORTATION SERVICES 206-221-3701 | [email protected]

Register Study on Participate in Research

Researchers can post their trials to www.ParticipateInResearch.org , and potential volunteers can search for studies that apply to them. This website was developed by the Institute of Translational Health Sciences in partnership with the UW School of Medicine’s Office of Research and Graduate Education to connect research teams with members of the community.

Set Up the Study Binder

Regulatory binders help research teams organize their files, maintain regulatory compliance, and adhere to Good Clinical Practice (GCP) standards for record keeping practices for research involving human subjects. Most sponsors/Clinical Research Organizations will provide the organizational forms and supplies they require you to maintain throughout the trial.

Helpful background can be found in Section 8, “Essential Documents for the Conduct of a Clinical Trial,” of the Food and Drug Administration’s guidance document E6, Good Clinical Practice: Consolidated Guidance.

Do a Walk Through

To make sure you are prepared to conduct the trial, do a walk-through of the research procedures before you schedule the first visit:

• Confirm pre-screening steps in Epic and ORCA
• Create visit packets that contain your recruitment, consent, and data collection resources you will use when approaching participants
• Role play a recruitment conversation using the recruitment script
• Pretend to schedule a study visit
• Role play an informed consent discussion
• Walk from the place where you’ll meet the participant to the visit location(s)
• Make sure you have everything you need at the visit location(s):  lab kits, MD orders, pharmacy communication, lab requisition slips, data collection forms, laptop to access eCRFs/regulatory docs, equipment calibrated and in working order, mailing/shipping containers
• Review data collection forms (CRFs) and confirm access to electronic data entry system

Training/Credentialing

Human subjects protections training.

There is no institutional-wide requirement for human subjects training at the University of Washington. However, many sponsors, funding agencies, UW departments, and collaborating institutions require that all members of the research team have completed a standard training course on the protecting human subjects in research.  The Collaborative Institutional Training Initiative (CITI) web-based training meets the requirements of most industry sponsors.  To take a course on the CITI website, you must register for an account and then affiliate yourself with the UW.

UW HUMAN SUBJECTS DIVISION TRAINING (206) 543-0098 |  [email protected] Human Subjects Division website

Clinical Trial Policy Training

University of Washington’s Clinical Research Budget & Billing (CRBB) support office provides Clinical Trial Policy Training to ensure that all UW Medicine faculty have a uniform knowledge of the regulations governing clinical research and that they understand the internal processes that have been implemented in order to maintain compliance in clinical research billing.

Your research support staff may also need to complete the CRBB modules within the UW Medicine Clinical Research Staff Training Program (CRB1, CRB2, CRB3) .

HIPAA Training

UW employees who are involved with research conducted with UW Medicine facilities must complete “HIPAA Online Training” and sign the “UW Medicine Privacy, Confidentiality and Information Security Agreement” within the first 30 days of the individual’s first day as a member of the research team.

UW MEDICINE COMPLIANCE  (206) 543-3098 |  [email protected] HIPAA Privacy and Information Security Training

Epic Training

For trials that utilize UW Medicine clinical facilities, investigators (or their designees) are required to use Epic scheduling software to enter research subject enrollment status information and to forward study-related admission notifications to the UW Clinical Research Budget and Billing office. To do this work, members of the research team need to complete Epic training and obtain access to Epic.

Register for the Epic classroom training course, RES110: Epic Research Participant Enrollment.

EPIC REVENUE CYCLE OPERATIONS EDUCATION [email protected] UW Medicine Account Activation Request Form

Bloodborne Pathogens Training

Principal investigators are responsible for assessing research activities to determine if members of the research team have a potential for exposure to human blood and its components, human tissue, all human cell lines, human source materials, as well as medications derived from blood (e.g., immune globulins, albumin) and other potentially infectious materials. If your research activities involve human blood and its components, you and your research team are required to comply with the UW’s Bloodborne Pathogens Program, which includes a training requirement.

UW ENVIRONMENTAL HEALTH AND SAFETY Training Administration (206) 543-7201 |  [email protected] Bloodborne Pathogens Program

Radiation Safety Training

Members of your research team may need to complete radiation safety training or review “Radiation Safety Training for Ancillary Personnel.”

UW ENVIRONMENTAL HEALTH AND SAFETY Training Administration (206) 543-7201 |  [email protected] Radiation Safety Training for Ancillary Personnel Radiation Safety Training

Shipping Biohazards Certification

If your research team will package and ship specimens via land, air, or sea, all team members must be trained and certified to ship hazardous materials. There are prescriptive requirements for packaging and labeling of hazardous materials and for the associated documentation used in the event of an emergency. There are fines for lack of certification and improper packaging and, worse, a chance for loss of life and property.

UW ENVIRONMENTAL HEALTH AND SAFETY Training Administration (206) 543-7201 |  [email protected] Shipping Hazardous Materials

UW Medical Center Credentialing

The UW Medical Center credentialing process ensures that individuals other than physicians, Nurse Practitioners, and Physician’s Assistants who interact with patients at UW Medical Center are competent to practice in their role and have current immunizations to ensure the safety of the patients. Members of your research team interacting with UW Medical Center patients must have current credentialing.

UW MEDICAL CENTER CREDENTIALING [email protected] Credentialing

Site Initiation Visits: Starting Your Trial On Track

Presenting The Protocol The CRA’s task is not only to present the protocol, but to engage the team. The doctors, nurses and pharmacists involved in the study are busy, and making them sit through hundreds of presentation slides may not give the trial the best start. Instead, the CRAs give the team the chance to ask questions, in an interactive session. They answer any questions the PI and other staff have about the study, and address any issues before the trial starts. The presentation might cover the design of the trial, the drug or treatment being tested, and any relevant background information about the therapeutic area, always keeping the audience in mind. Details like eligibility criteria for enrolment, how to store and administer the drug, and quality management points are also included.

The Trial Walk-Through In a meeting with everyone involved, the CRA will lead the group in a walk-through of the study, often from the perspective of a participant. By looking at the process from enrollment to trial end, the CRA can ensure the whole team understands what lies ahead in the trial. They can also identify any gaps in knowledge and spot potential problems before they arise.

Checking Documentation And Equipment The SIV includes some logistical and physical checks. The CRA checks that the drug is on-site, available and correctly stored. They ensure the team has the necessary equipment, such as lab kits or ECG machines, and that those who need access have it. The CRA checks the relevant documentation has been completed, such as regulatory documents, informed consent documents. Finally, they ensure the relevant team members have access to the systems and portals they will use during the trial.

Why Experience Matters

While every study is different, a CRA applies the same skills to make each SIV a success. With experience across a range of trials in different therapeutic areas, a CRA can take the most effective approach to their presentation of the protocol, answer questions about the trial with confidence in their knowledge, and cover all bases to get the trial started in a positive direction.

At Siron Clinical, our CRAs have at least 15 years’ experience in setting up and running clinical trials – including site initiation visits. Find out more about how we can support you .

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Site Initiation Visit (SIV)

Written by Jeanne Lovmo on June 3, 2022 .

A meeting with a representative of the sponsor to prepare the research site to conduct the research study . The SIV occurs prior to initiation of enrollment , generally after the investigational site has received IRB approval and a Clinical Trial Agreement (CTA) has been fully executed. The Principal Investigator (PI) or member of the research team will schedule and arrange the SIV which can be conducted in person, on-line, or via conference call at the discretion of the sponsor. The sponsor representative leads the meeting and provides protocol training for the PI and delegated research team members .

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Clinical trial basics: site initiation visit (siv).

What is an SIV in clinical research?

SIV Definition: Site initiation visit

An SIV (clinical trial site initiation visit) is a preliminary inspection between the sponsor and the trial site before the enrollment and screening process begins. It is conducted by a monitor or clinical research associate (CRA), who reviews all aspects of the trial, from protocol to 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 agreements such as the CTA and CDA have been signed.

What is the purpose of an SIV?

Clinical trial SIVs are necessary to ensure that all personnel involved in the clinical trial, such as investigators and study staff, thoroughly understand the trial protocol and are trained to handle their role and responsibilities.

Furthermore, a site initiation visit ensures the trial site is operational-ready with working infrastructure, tools, and materials which helps streamline future efforts such as recruitment. [ 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.

Can the SIV be conducted before IRB approval?

IRB approval is necessary before an SIV. Clinical trial sponsors need to be sure they have selected a site that has fulfilled all the necessary regulatory requirements and is operating in compliance with IRB guidelines.

SIV checklist for thorough site initiation visits

Given the importance of an SIV, clinical trial sponsors and CROs need to make the most of this inspection visit by coming fully prepared with a detailed checklist that outlines the SIV.

Clinical trial sites should also have a copy of this checklist to ensure all relevant staff is present. Specific tasks to include in the SIV checklist include the following tasks: [ 1 ] [ 2 ][ 3 ][ 4 ]

• Discussing clinical trial 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 inclusion and exclusion criteria
• Reviewing the informed consent protocol
• Clarifying the procedure of storing and dispensing the investigational drug
• Checking inventory for all medical supplies and equipment
• Ensuring access to all digital platforms, i.e., correct usernames and passwords
• Touring the clinical trial site
• Reviewing and discussing all clinical trials documentation, such as forms, surveys, and manuals
• Reviewing the data management system
• Ensuring clinical trial staff understand how to maintain essential documentation
• Reviewing the financial protocols, including any processes related to compensating trial participants
• Checking reporting systems for possible adverse events
• Discussing specific concerns trial staff may have

This checklist provides the basic guidelines that can be used to build upon to create a complete agenda for an SIV. Clinical trial sponsors can add to these as required per their clinical trial design.

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Conducting Successful Site Qualification Visits using Virtual Solutions

August 18, 2020

On-site facility evaluations have historically provided us with the insight necessary to determine site performance and viability for our clinical trials. With decentralized trials as a mainstay of the current clinical research landscape, it’s imperative to leverage the virtual resources available to cultivate those same meaningful evaluations and assessments, safeguarding patient safety and data integrity.  We were able to achieve such success when we completed 12 virtual, customized, site feasibility assessments of facilities located throughout the U.S. for a respiratory study. Given the current resurgence of COVID-19, the safety of site staff and our study team was paramount. To minimize the risk to the sites and our CRAs, we elected to conduct the site qualification visits virtually, which required creating hybrid approaches to utilizing our virtual platforms.

Pre-planning

Advance preparations were critical when it came to planning our virtual Site Qualification Visits (SQV). Based on our prior decentralized trial experience, we were able to quickly assess the data we needed from our virtual visits to make the most confident decisions selecting our sites.  After reviewing each site’s feasibility questionnaire, we emailed the site asking them to provide their scheduling availability over the next few weeks. In addition, we realized the value of having all the stakeholders together in the meeting and requested that the following key site personnel attend the visit, which we expected to take 3-4 hours.

• Principal Investigator (required, approximately 1 hour)
• Research Coordinator(s) (required, entire call)
• Pharmacist (required, 30 minutes)
• Sub-Investigators (optional)
• Regulatory staff member (optional)
• Contracts/budgets Manager (optional)

We were able to manage expectations by noting the amount of time each person would be needed on the call and we offered flexible scheduling options to accommodate staff that were unavailable on the primary visit date/time.

Virtual Platform Solutions

During the remote SQVs, we wanted to tour the facilities and equipment, including the pharmacy, and made sure that the sites had the ability to conduct a video tour of the noted facilities during the call. Our CRA confirmed access to alternative video-conference technology with the site that we could use as “back-up” if platforms such as WebEx or FaceTime didn’t work or weren’t available. Some platforms may compromise organizational security and confirming which technologies are available and/or accessible per institutional IT policies are key to ensuring a successful virtual visit.

The assigned CRA set up a WebEx session with web camera capabilities as one method of conducting the virtual tour. One of the sites had pre-recorded a video tour of their facilities and had the link accessible to preview via YouTube, which the CRA was able to view as an additional resource. The live tour was conducted during the SQV to confirm that all study specific requirements were met. Clearly, sites are adjusting to this COVID-world and are proactively finding ways to address the standard request.

The main presentations were conducted via WebEx and then the Site Coordinator/CRA had the option to switch to FaceTime for the tour, which proved to be a more convenient option using a smaller device to conduct the tour. Of note, there are other virtual platforms, such as WebEx, that have robust phone applications, which may be preferable to carrying a laptop around a facility. The transition from WebEx to FaceTime took some extra time, but once that happened, the CRA communicated this change to site personnel for subsequent visits, so that they were prepared and timelines weren’t impacted.

Of the 12 SQVs we completed, we selected 8 viable sites and 2 alternative sites based upon the nuanced criteria we collected during the tour. We leveraged our past experience to adapt our preparations for the SQVs. The virtual platform strategies we employed significantly shortened the SQV time period within the study start up timelines, reduced travel costs, created user friendly assessment options and flexibility, and above all, protected all staff from any COVID-related risks.

Hybrid virtual applications in clinical trial processes can positively impact the course and integrity of the trial. To realize the advantages and benefits of a well-executed virtual clinical development program, it’s critical to partner with a CRO with experience planning and implementing successful decentralized solutions.