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Patient Pre-Screening Best Practices in Clinical Research

Pre-screening can be a very impactful step in the clinical trial process, serving as the first filter to determine the potential eligibility of candidates before they undergo more comprehensive screening procedures. This preliminary assessment can be conducted via telephone, where basic medical history and current medications are discussed with the patient, or through a more detailed in-person visit where more procedure-based information like Pulmonary Function Tests (PFTs), glucose screenings, blood pressure measurements, etc can be collected.


Why Implement Pre-Screening?


  • Global Patient Assessment->Enhanced Recruitment Rates 

    • Beyond immediate trial needs, pre-screening offers a global view of a patient's potential research involvement. This holistic approach allows for strategic planning across multiple trials. By understanding a patient's comprehensive health profile early on, sites can more accurately determine suitability across all active studies. This broad assessment aids in boosting enrollment rates by quickly identifying the best matches for each study.

  • Reduced Screen Failures:

    • Pre-screening mitigates the risk of screen failures—participants who fail to meet the trial's eligibility criteria after the initial enrollment. High rates of screen failures are not only costly but can also draw negative attention during FDA audits.

How to Streamline Pre-Screening with Eligibility Automation - A Step-by-Step Guide


Implementing an automated and streamlined approach to pre-screening can significantly enhance the efficiency of patient recruitment for clinical trials.


STEP 1: Set-Up Quri AI Chart Review: Create an Account and Add Your Studies


AI Chart Review is advanced eligibility analysis tool trained to assess patient data to see if they match your study's criteria. Simply upload patient documents (i.e. medical records, pre-screen intake forms, etc) and AI will analyze to see which studies they match the criteria for (w/ a full eligibility report with reasoning).


For each study, you typically add a comprehensive set of inclusion/exclusion (I/E) criteria and prohibited medications to thoroughly assess patient eligibility for each study. HOWEVER, for each study, create a simplified version labeled "PRE-SCREEN" which encompasses a broader, more general set of criteria. This should focus on key eligibility factors that are typically available from preliminary patient data you're collecting.


STEP 2: Engage Potential Participants


Contact potential participants who have responded to advertisements or have been referred. Verify their interest and availability for participation.


Send electronic consent forms and medical record release documents to be signed digitally. This ensures all legal and compliance frameworks are adhered to before collecting any personal health information.


Set-up a time with them to conduct your Pre-Screen Visit (either on-phone or on-site)


STEP 3: Intake Patient's Medical History, Medication List, and other Procedure-Based Information (if on-site)


During the initial phone call, gather essential health and medication history. This stage aims to collect enough information to assess basic suitability for the studies. If in-person, conduct detailed diagnostic tests and evaluations.


Systematically document all collected data either through a structured intake form

  • Directly into their patient profile on your CTMS (example below)

  • Filled-out intake form/questionnaire


STEP 4: Upload the Patient Profile (downloaded from CTMS or your PDF pre-screen intake form) to Quri AI Chart Review


Select all your "Study - PRESCREEN" to run eligibility analysis


The Quri AI system rapidly evaluates the uploaded data against the pre-screen criteria of each study, providing a list of potential study matches along with detailed justifications for each.


STEP 5: Double-Check Eligibility Reports


It's always great to validate the AI's findings and see if there is any further information needed to be collected or assessed.



Let's Take it a Step Further?


Quri is working with pilot development partners to take this pre-screening automation a step further. Imagine a solution where the HIPAA-Compliant AI is listening and transcribing your pre-screening calls and visits, and instantly sending this data to Quri for eligibility assessment across all your studies in real-time


Let's Get in Touch!


 
 
 

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