Pre-site selection visit (PSSV) or site qualification visit (SQV)Site Selection Visit

Now that we know the phases of clinical trials, let’s discuss how clinical trial is conducted at a site.

Typically, sponsors engage with Qualified Investigators or Site Managers to discuss the testing of a new drug or exploring an existing drug for a different indication. Before sending the protocol for feasibility assessment, a Confidentiality Disclosure Agreement (CDA) is signed between the sponsor and the pre-qualified Qualified Investigator (PI) or Site. The PI’s qualifications and site suitability are evaluated, either through information provided by the PI or based on the sponsor’s research. Following CDA execution, the sponsor provides the protocol to the site, which may request additional documents such as the Investigator’s Brochure (IB), Product Monograph (PM) for approved drugs, pharmacy manual, lab manuals, and other relevant documentation. Subsequently, the sponsor conducts a Site Selection Visit (SSV), also referred to as a Pre-Site Selection Visit (PSSV), Site Evaluation Visit (SEV), or Site Qualification Visit (SQV).

A pre-site selection visit (PSSV) or site qualification visit (SQV) is a crucial step in the initiation of a clinical trial. It involves assessing potential investigational sites to determine their suitability for participation in the study. Here’s a detailed discussion of the purpose, process, and key considerations of PSSVs or SQVs:

Purpose:

1. Site Assessment: The primary objective is to evaluate potential investigational sites based on their capabilities, resources, and experience in conducting clinical trials. This assessment helps ensure that selected sites can meet the study requirements and adhere to Good Clinical Practice (GCP) guidelines.
2. Risk Mitigation: PSSVs/SQVs aim to identify any potential risks or challenges that may affect the conduct of the trial at a particular site. Addressing these issues early on helps mitigate risks and ensures the smooth execution of the study.
3. Relationship Building: PSSVs/SQVs provide an opportunity for sponsors or clinical research organizations (CROs) to establish rapport with site personnel. Building a collaborative relationship fosters communication and cooperation throughout the trial.

Process:

1. Planning: Before conducting PSSVs/SQVs, sponsors/CROs develop a checklist or assessment criteria based on the study protocol, regulatory requirements, and sponsor-specific standards. This checklist typically includes items such as site infrastructure, personnel qualifications, previous trial experience, patient population, and regulatory compliance.
2. Site Selection: Potential investigational sites are identified based on factors such as geographical location, patient population, and site capabilities. Sites may be selected from a pool of interested investigators or through site feasibility assessments.
3. Visit Preparation: Site personnel are informed in advance about the purpose and agenda of the PSSV/SQV. Relevant study documents, including the protocol, investigator’s brochure, and regulatory documents, are provided to the site for review.
4. Site Visit: During the visit, representatives from the sponsor/CRO meet with site personnel, including principal investigators, sub-investigators, research coordinators, and administrative staff. In some cases, the PSSV/SQV is conducted by phone; in others, sponsor representative(s) pay a visit to the site and tour the facility. Discussions cover various aspects, such as site facilities, staff qualifications, recruitment strategies, data management capabilities, and compliance with regulatory requirements.
5. Assessment and Documentation: Observations and findings from the site visit are documented in a report or assessment form. This report serves as a basis for decision-making regarding site selection and further site training, if necessary.

Key Considerations:

1. Site Capabilities: Assess the site’s infrastructure, facilities, equipment, and personnel to ensure they meet the requirements of the study protocol.
2. Experience and Expertise: Evaluate the site’s previous experience in conducting clinical trials, particularly in the therapeutic area of the study. Consider the qualifications and training of the principal investigator and research staff.
3. Regulatory Compliance: Verify that the site adheres to applicable regulatory requirements, including Institutional Review Board (IRB) or Ethics Committee approvals, informed consent procedures, and documentation practices.
4. Patient Population: Assess the site’s ability to recruit and retain the target patient population specified in the protocol. Consider factors such as patient demographics, disease prevalence, and access to potential study participants.
5. Communication and Collaboration: Establish clear lines of communication between the sponsor/CRO and the site. Foster a collaborative relationship based on mutual trust, respect, and transparency.

Pre-site selection or qualification visits are crucial in ensuring the successful initiation of clinical trials by identifying suitable investigational sites and addressing potential challenges early in the process.