Site Qualification Visit (SQV)
Engage the client in evaluating the benefit of having a qualification visit. SQVs can be performed remotely with the support of other factors and documentation. If need be, waiving the formal visit may be an option if procedures and policies allow.
Items to consider:
- Develop or continue to use a qualification questionnaire to obtain important site feasibility information.
- e.g., investigator experience, time and resources to perform the study, facilities, identified staff
- Conceptualize all site spaces for the designated study that a monitor would need to tour to think of key questions to ask regarding site facilities. (e.g., “Is the monitoring space adjacent to IP storage or is it in another building a 10-minute walk away?”)
- Use internal CTMS system data to collect intel on the site, including past experiences and results.
- In lieu of a CTMS system, reach out to coworkers who may have had first-hand experience with a site and can provide important information that is otherwise garnered from an in-person visit. They can often assist in confirming questionnaire responses by drawing upon their real-life experience.
- Work within individual site restrictions and policies to see if a remote SQV is possible.
- If performing a remote SQV, take into consideration that staff resourcing at healthcare facilities is in demand. Utilizing the qualification questionnaire and previous research, complete the SQV report and identify critical areas for discussion, noting how much time you will require of any study staff.
- As physicians are in high demand, try to limit the PI portion of the SQV to 15–20 minutes, with a focus on the PI’s responsibilities and enrollment requirements. Study coordinators can cover the remaining information of the study startup process and remaining logistical information.
Site Initiation Visit
Work with the client to see where overarching procedures and policies have flexibility and come up with creative strategies for overcoming current obstacles.
SIV Presentation
Utilize platforms such as Microsoft Teams or Webex to conduct a remote conference call and
present slides to the study team.
Device or Product Training
- In some cases, remote training may be feasible and can be completed.
- If device or product training needs to be in-person, consider initiating a site with the caveat that they are not allowed to enroll (or implant, or perform procedures) until formal in-person training is completed and documented in the site initiation visit report, or activation checklist, etc. In some cases, remote training may be feasible and can be completed.
Regulatory Documents
- Provide site coordinators with regulatory document templates necessary for site activation before the scheduled SIV in order to have all required signatures collected before or at the time of the remote SIV. Signatures may be collected as wet ink signatures or digitally, working with the CTAs to have them sent out using DocuSign.
Site Reference Manuals and Site Binder Materials
- Instead of supplying binders filled with the template logs, charts, protocol, case report forms, source document worksheets, and everything else that study personnel would want and need to keep on file for reference for a trial, consider supplying the documents through a secure virtual space where study personnel can access and download as needed (SharePoint or Microsoft Teams).
- When supplying study materials in this manner be sure to confirm with site, ahead of the scheduled visit, any electronic transmission issues due to institutional firewalls (e.g., site cannot utilize USBs, zip files, etc.).
- Consider supplying the training logs (and any other forms needed at the SIV to complete the site activation checklist) to the site in a pre-populated format to avoid any confusion or further delay in activation while in the remote setting.
Connect with the site to be sure they are able to complete a remote SIV. Sites have different regulations that must be followed, and they can vary from site to site — plus they may change as institutions work toward remote solutions at this time.
Interim Monitoring Visit
Develop contingency plans with the sponsor, taking into account potential limitations. Potential limitations may include:
- Access to EMR
- Access to study documents
- Bandwidth of site personnel to redact documents or provide remote access
- Data entry abilities
- Critical variables
- Patient safety
A full or partial remote monitoring visit may be appropriate if the site has the following:
- Access to EMR
- Access to study records
- Access to regulatory records
- Bandwidth to redact source documents (or provide monitor with remote access to records, e.g., direct access to EPIC, etc.)
- In the event that remote monitoring is an option for your study, ensure that you are making the most efficient use of your site’s time. Target critical variables — further follow up can be conducted at a later date when on-site monitoring can resume (e.g., full monitoring of first patient).
- If critical variables have not been identified, work with the client to pinpoint them.
- Revisit the variables for visits and make a determination, based on what might be considered standard of care versus research-related only, as to which variables you may be able to anticipate being available, if any.
- Redacted source — Determine each individual site’s capabilities for access to and supply of redacted source. Gaining this knowledge prior to the IMV will allow monitors to provide the site with a list of targeted documents that will be needed.
- Are study personnel still on-site?
- Do study personnel or monitors have remote access to the EMR system?
- What is the institution’s policy on remote monitoring and sharing redacted source?
- Was is the bandwidth available to provided resources to supply redacted source if needed?
- Is site source redaction work built into the current clinical trial agreement?
- Tip: Always have a conversation with the sponsor regarding additional tasks for the sites if not previously agreed upon.
- Be flexible.
- Work with the source documentation that is available.
- Continue to narrow critical information — If site is limited, then maybe a narrowing of information to monitoring means changing from a focus on critical variable monitoring to a focus on eligibility criteria and safety oversight. Furthermore, a partial remote visit could even be performed on the redacted adverse event paperwork completed for patients thus far.
Even though a monitoring plan may dictate when a visit should occur doesn’t mean that, given the current health landscape and action plans in place to mitigate risk and place patient safety first, a visit is warranted. Sponsors may ask that visits be placed on hold. When making this decision with the sponsor, take into consideration:
- How many currently enrolled patients are able to continue with follow-up visits?
- Do site personnel have the bandwidth/tools/resources to complete data entry to be monitored?
- What is the risk of placing these visits on hold in terms of patient safety?
A remote visit allows us to maintain consistency and site oversight, but in the event that the decision is made to hold the visit, ensure to maintain a means of contact and “monitoring.”
- Touch-base phone call(s)
- Regular email conversations with attachments if allowed
- Webexes
- Query EDC CRF entries as applicable
Maintaining communication regardless of a temporary change to monitoring procedures is crucial. All efforts should be made to monitor patient safety.
Health facilities are continuing to work on tackling these obstacles and unveiling new solutions and policies every week. It is important to stay in touch and be aware so that if and when a site that was previously unable to participate in remote IMVs suddenly has a new system in place that is validated for uploading redacted source and ready for use, you know about it and can expand your monitoring capabilities.
Tip: Create a COVID-19 study tracker with all sites listed and the restrictions currently in place. Update regularly as you stay in contact with all sites. Use this tool to stay up to date on their ability to participate in completion of remote monitoring and standard trial practices otherwise completed regularly.