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Clinical Operations and Monitoring

ACRP Alliance PartnerSuccessful study execution requires more than just source data verification (SDV) and on-site clinical monitoring.  Our clinical operations team ensures efficient study start-up, quick enrollment, and high quality execution at the site-level through extensive therapeutic and regulatory knowledge, solid training programs, and development of strong site relationships. 

From project initiation through site selection and activation, our clinical operations team makes sure first patient first visit (FPFV) goals are met by conducting a thorough feasibility process and onsite qualification visits.  During the enrollment and treatment phase, they keep a close eye on recruitment and retention, data quality, protocol deviations, and more to ensure that database lock happens promptly following last patient last visit (LPLV).

Study start-up

Identifying the right sites is critical to patient recruitment and successful execution of overall study timelines. The clinical operations team does this by:

  • Evaluating the competitive landscape to determine studies competing for sites and subjects. 
  • Conducting thorough feasibility to determine how many and which sites are needed
  • Maintaining relationships with high performing sites that have a proven history of meeting enrollment goals and generating high quality data
  • Assessing sites through qualification visits

Once sites are selected, the clinical operations team works diligently to complete study start-up activities needed for FPFV such as:

  • Collecting site regulatory documents needed for IRB approval
  • Managing site budget and contract negotiations
  • Tracking IRB and contract dates to ensure prioritization and acceleration of site activation
  • Conducting site initiation visits
  • Participating in investigator meetings and training site staff

Enrollment and treatment

During the enrollment and treatment period, the primary goals of the clinical operations team are to ensure quality in the execution of the study and to mitigate risks to study timelines by keeping enrollment on track.  Some keys to meeting these goals are:

  • Building and maintaining close relationships with sites so that issues are identified and resolved quickly
  • Maintaining oversight through timely trip report review and co-monitoring visits
  • Tracking enrollment, protocol deviations, AEs, investigational product, and clinical trial materials
  • Review of site trends via centralized clinical monitoring to ensure consistency and quality of the data.

Close-out

Real-time data cleaning and listing review during the enrollment and treatment phase expedite study close out and database lock.  Our clinical operations team works closely with the data manager to ensure that data from sites is submitted in a timely manner.  Quick and thorough close-out activities lead to efficient and on-time database lock and delivery of critical topline results.

Risk Based Clinical Monitoring

Risk based monitoring (RBM) can be an effective strategy in many trials with a straightforward study design, a low risk patient population, and involving a product with no known serious safety concerns.  For qualifying studies, a targeted clinical monitoring strategy is prepared at the time of study start up. The focuses of on-site monitoring are key endpoints and safety measures that are of particular relevance to the trial.  A typical risk based monitoring strategy would include a combination of centralized monitoring activities and targeted/adaptive source document verification (SDV) during on-site visits.   

Centralized monitoring is remote clinical monitoring at a location other than the clinical site. Centralized monitoring involves:

  • Remote monitoring: This includes remote SDV of variables such as laboratory values, ECGs and other centrally collected data, IXRS reconciliation, query follow up, and remote correspondence.
  • Real-time Summary Metrics: These are summary evaluations that are empirical (e.g., counting number of protocol deviations at sites) or statistics based (e.g., formally comparing distributions of data between sites).  In our experience, these summary metrics produce higher quality data than traditional monitoring alone.  They allow the project team to identify study-level trends, issues, data inconsistencies throughout the life cycle of the study and focus efforts once on-site.

On-site clinical monitoring includes targeted SDV focused on primary endpoints as well as targeted safety assessments.  More extensive monitoring occurs if pre-defined risk parameters are met or exceeded as outlined in the clinical monitoring plan.  The adaptive approach allows for the intensity of the monitoring to be increased or decreased during the trial based on key performance or risk indicators.

This streamlined approach to monitoring reduces the burden of on-site visits for the sites as well as the overall monitoring budget, while not sacrificing the quality of the data.