20.2 Recruitment Feasibility and Evidence-Based Site Selection

Recruitment Feasibility and Evidence-Based Site Selection

Recruitment difficulty can be a cause of clinical trial delays and premature study termination. The CRA must rigorously interrogate the site's recruitment assertions:

• Diagnostic Epidemiology vs. Protocol Criteria: The CRA reviews recent historical patient volumes from the site's Electronic Health Record (EHR) database. Rather than accepting broad claims like "We see 500 diabetes patients a year," the CRA applies specific protocol eligibility criteria: How many of those 500 patients have an HbA1c between 7.5% and 10.0%, are free of advanced renal impairment (eGFR $\ge 60\text{ mL/min}$), and are not taking exclusionary medications? Often, an initial pool of 500 shrinks to 15 eligible candidates.
• Historical Enrollment Metrics: The CRA verifies site performance on past comparable trials. Did the site meet its contracted enrollment targets, or did it fail to enroll or require contract amendments?
• Competing Clinical Trials: The CRA must audit all active and upcoming studies at the institution. Are other investigators within the clinic or adjacent departments running studies targeting the exact same patient population? If two competing trials target third-line metastatic breast cancer, how will eligible patients be allocated between the studies?

D. Facilities, equipment and continuity

Verify facilities against the actual protocol: product storage and environmental monitoring, sample processing, imaging or other diagnostics, secure records and appropriate emergency support. Calibration, maintenance and contingency arrangements should fit the equipment and risk. Do not assume every site needs the same freezer, generator or brand of temperature logger.

Request evidence: an equipment identifier, service record, required operating range, current calibration where relevant and a workable failure response. Ask staff to describe an out-of-hours alarm or a courier cancellation. A device present in a room is not proof that trained staff, compatible supplies or backup arrangements are available. Remediable gaps should have owners and evidence of correction before the affected activity begins.

E. Institutional Review Board (IRB) / Ethics Committee Processes

Institutional ethics review workflows dictate study activation timelines:

• Central IRB vs. Local Institutional IRB: Does the institution permit reliance on an independent central IRB (e.g., WCG, Advarra) via a Master Services Agreement, or does institutional policy mandate review by an internal hospital IRB?
• Submission Deadlines & Meeting Calendars: Internal IRBs often meet only monthly, requiring submissions 3 to 4 weeks prior to the meeting date. If a submission window is missed, activation is delayed by 6 to 8 weeks.
• Ancillary Committees: Institutional delays frequently stem from ancillary committees, such as Institutional Biosafety Committees (IBC) for gene therapies, Radiation Safety Committees (RSC), or internal Scientific Review Committees (SRC).

Evaluating significant concerns

Verify investigator qualifications and regulatory standing as applicable to the jurisdiction and protocol. ACRP's ECO includes verifying appropriate qualifications and standing, but no ICH global disqualification directory exists. Relevant restrictions, unresolved prior findings, unwillingness to provide access, inadequate oversight or resources, and unreliable recruitment evidence can affect suitability.

A previous observation or warning is not automatically proof that every future trial is prohibited. Review the actual restriction, corrective actions and current evidence with sponsor regulatory/quality functions. Conversely, a strong recruitment record cannot compensate for a legal restriction or unresolved serious risk. Document the facts and rationale, and let the authorised sponsor function make the selection decision.

Competing studies and staff turnover are feasibility risks to assess, not universal automatic exclusions. Quantify the eligible pool and capacity, establish a workable allocation/coverage plan and verify it rather than applying invented thresholds such as a maximum trial count or percentage of annual turnover.

CRA Documentation: The PSV Report and Objective Recommendation

Following the visit, the CRA synthesizes all clinical, operational, and facility data into a formal, auditable Pre-Study Visit Report.

Report Contents and Structure

The PSV report must document concrete, factual observations rather than vague impressions:

• Detailed meeting minutes with the PI, Sub-investigators, lead CRC, and research pharmacist.
• Specific equipment serial numbers, calibration stickers, and temperature logging curves inspected during the walk-through.
• Verified historical patient recruitment rates and institutional database search results.
• Comprehensive list of active competing clinical trials and the site's patient allocation strategy.
• Anticipated IRB review timelines, contract negotiation terms, and budget parameters.

The Site Recommendation Framework

The CRA concludes the report with a clear, evidence-based recommendation across one of three standard categories:

1. Selected / Recommended: The site possesses exceptional qualifications, demonstrated patient volume, modern equipment, experienced personnel, and an engaged PI with verifiable time.

2. Conditionally Approved: The site demonstrates strong clinical potential but possesses minor, remediable deficiencies (e.g., the pharmacy needs to install a secondary appropriately calibrated backup data logger, or the site must identify and train a designated backup coordinator). Formal selection is withheld until written proof of remediation is verified.

3. Rejected / Disqualified: The site displays insurmountable operational vulnerabilities, unaddressed regulatory sanctions, inadequate patient volume, an uncooperative or overextended investigator, or severe infrastructure defects that compromise study integrity.

Official sources

Checked October 18, 2026: ICH E6(R3), Principles and Annex 1, ICH E8(R1).