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.