Summary
Highlights
The webinar begins by introducing the full spectrum of managing a clinical research process, from startup to closeout. Speakers share their recent experiences with site selection and initiation visits, highlighting common challenges such as inadequate preparation from sites and the need to combine initial visits due to lack of prior site selection.
The core essentials for clinical research include a site, a Principal Investigator (PI), a study coordinator, and most importantly, patients. Without studies, revenue cannot be generated, emphasizing the importance of business development. Strategies include searching clinicaltrials.gov, drugde.org, and CRO databases, and consistently following up with contacts. It's a numbers game; persistence is key, as many contacts may not respond or respond unfavorably.
Timely response to CDAs is crucial. Sponsors/CROs often require quick turnarounds (within two weeks, sometimes as little as two days). Missing these deadlines usually means forfeiting the opportunity to participate in the trial. While study-specific information cannot be shared, contacts for studies can be forwarded to colleagues. Sites must review and return CDAs promptly to avoid being overlooked, as there are many sites competing for studies.
After a CDA, a feasibility survey is often sent to gauge a site's capabilities. This survey assesses the investigator's experience, coordinator's experience, patient database, and past study experience. The most critical factor is the ability to recruit patients. While sites often exaggerate capabilities, consistency between the survey and the PI's responses during the SSV is vital. SSVs can be in-person or remote, but timely responses for scheduling them are necessary. After the SSV, sites receive a selection letter, and follow-up is encouraged even if not selected, to understand areas for improvement.
Sites should generally accept more studies than they think they can manage, with the caveat of being able to enroll at least one patient per study. This is because studies can end quickly due to real-time data analysis. If overwhelmed, sites can prioritize recruitment in higher-paying studies. Negotiating contracts and budgets is essential, as initial offers from CROs/sponsors are rarely the best. Budget negotiations should be turned around within one to two weeks, not left to sit in an inbox.
Startup and regulatory processes can be overwhelming for new sites. Key documents include the 1572, financial disclosure, IRB questionnaire, and delegation of duties log. These should be completed before the Site Initiation Visit (SIV). Initial IRB submissions are also necessary for site approval. Other essentials include regulatory binders, lab kits, investigational product, and training (GCP, study-specific, IATA, EDC, ECG, etc.). All training must be completed before the SIV.
The SIV involves the monitor assessing the site's readiness, conducting protocol training, and ensuring all necessary equipment and documents are in place. Sites should not begin screening patients until explicitly cleared. Creating source documents, though time-consuming, ensures adherence to the protocol's schedule of assessments and helps coordinators learn the trial. Following the site's own Standard Operating Procedures (SOPs) is critical to avoid audit findings.
Coordinators are the backbone of any study, doing the majority of the work. Their performance determines if a site is rated 'green' (excellent), 'yellow' (issues but worth considering), or 'red' (never use again). Interim monitoring visits occur every six to eight weeks to verify data, address discrepancies, ensure protocol adherence, and review regulatory binders. A good relationship with the CRA is beneficial, and understanding payment triggers for visits is key.
During database lock periods, all data up to that point must be entered, free of queries, and locked. This involves intense activity with EDC vendors and monitors, often leading to numerous emails and phone calls. Queries can sometimes be trivial, requiring patience. The study closeout visit occurs after all data is verified. The CRA ensures all remaining investigational product is handled, and the site sends a closeout report to the IRB. Final checks on regulatory documents and adverse event resolutions are also part of closeout.
Payment structures vary; some studies allow invoicing for screen failures or transportation, while others pay automatically based on EDC entries. Sites must understand their contract and identify payment triggers. Proactive follow-up with monitors is sometimes needed to ensure payments are processed. Most studies include a 10-20% holdback, released after all issues are resolved at closeout, serving as a bonus for good enrollment and compliance.