Congratulations! Your site has been selected to participate in a clinical trial, and the sponsor wants to schedule a pre-study qualification visit! But what, exactly, is a pre-study qualification visit (also known as a pre-site selection visit) and how do you prepare your site for one?
What is a Pre-Study Qualification Visit
Before a sponsor awards a clinical trial to a site, they will conduct a pre-study qualification visit. This process is designed to help sponsors select qualified investigators and determine the site’s ability to conduct the clinical trial. In order to be selected, investigators must be qualified by training, education and experience, and the site must have adequate resources, staffing and the facilities necessary to conduct the proposed study.
Preparation is Key
Site qualification visits can be simultaneously exciting and nerve-wracking due to the amount of communication and information gathering involved. The trick to completing a successful visit all comes down to preparation. Developing a plan of action for all three phases of the visit (prior to the visit, during the visit and after the visit) is key.
Prior to Site Qualification Visit
- Schedule the visit
- Suggest several potential meeting dates, allowing you and the sponsor plenty of opportunities to choose a time that works best for you both
- Ask for department tours and time allotments per department
- Knowing which departments the sponsor wants to visit, and the time allotted for each, will allow you to schedule out your visit as efficiently as possible
- Review the protocol and feasibility questionnaire
- Conducting these reviews ensures that you know what will be required of your site during the study, and will allow you to address any concerns prior to the qualification visit
- Consider patient recruitment strategies
- One of the top factors in site selection is your site’s ability to enroll patients. Have your enrollment strategies in place to further secure the trial award for your site
- Create a file that contains all site-specific documents
- Demonstrating that you and your site are well organized is highly important in site-selection. Keep all necessary documents in an easily identifiable, readily available location as your source documents, and have copies of all to give to the monitor during the site visit for the sponsor’s files
Documents to organize for the visit include:
- Standard Operating Procedures
- Lab Certificates
- Lab Normal Ranges
- Protocol Documents
- Feasibility Questionnaire
- Principal Investigators (PI)
- Study Coordinators
- Good Clinical Practices (GCP) Training Certificates
- International Air Transport Association (IATA) Training Certificates
During the Site Qualification Visit
- Be prepared to discuss the protocol
- Have a list of questions, concerns and deviations from your standard of care
- Share your informed consent process and enrollment/recruitment plans
- Document anticipated challenges
- Request the sponsor’s monitoring plan and their overview of data management strategy
- Discuss the protocol timeline
- Site selection
- Investigator meeting(s)
- Protocol initiation (First Patient First Visit)
After the Site Qualification Visit
- Submit your responses to any follow-up questions that arose during the visit
- Request a written notification of the trial award (email the sponsor frequently)
- If you were not awarded the trial, follow up with the monitor to understand the rationale
- Forward protocol documents to the appropriate team members to begin processing
- Regulatory documents
Following these best practices for site selection will put your site in the optimal position to be awarded a trial. For more information about securing clinical trials, read our blog, Securing a Clinical Trial – Best Practices Checklist, or contact us. GuideStar’s research team has years of experience with clinical trial start up, finance, compliance and communications.
GuideStar works with hospitals, health systems, academic medical centers and physician practices around the country to build and support clinical research programs. From helping organizations incorporate a clinical trial strategy to providing management guidance and support, our service delivery is based on operational and financial best practices to ensure optimal results for research programs.
Post by Marcus Creel -
As Marketing Manager, Marcus develops and implements branding and content strategy that ensures messaging accurately reflects the GuideStar brand image and engages each of the company’s target audiences.