Participant Management: Screening to Retention

Translate eligibility criteria into EHR queries, manage false positives, leverage research registries, and apply data governance principles for population-level participant identification.

Design and maintain a pre-screening log as an essential record, calculate recruitment funnel metrics, and prepare sponsor-ready pipeline reports.

Verify eligibility criteria systematically, navigate borderline cases with investigator adjudication, and document determinations with source-referenced evidence.

Document screen failures properly, conduct sensitive participant conversations, evaluate rescreening eligibility, and use failure data to improve recruitment targeting.

Complete enrollment documentation across source records, enrollment logs, EDC systems, and sponsor reporting with accuracy and regulatory compliance.

Track enrollment velocity against targets, prepare data-driven sponsor communications, adjust recruitment strategies based on pipeline analysis, and manage enrollment pressure ethically.

Execute visit procedures in correct sequence, document contemporaneously, manage participant experience, handle visit-day complications, and identify deviations in real time.

Review visit results systematically, communicate findings with investigator guidance, resolve data queries, and prepare for the next visit in the continuous care cycle.

Maintain the IP accountability log, perform reconciliation at defined intervals, prepare for monitoring visits, and manage IP return and destruction procedures.

Respond to temperature excursions with proper quarantine procedures, manage expiration proactively with FEFO, and classify and document IP handling deviations.

Document deviations with required elements, assess impact on safety and data integrity, conduct root cause analysis using 5-Whys methodology, and submit reports through required channels.

Design CAPA plans that target root causes, implement corrective and preventive actions with accountability, and monitor effectiveness to prevent deviation recurrence.

Distinguish intervention discontinuation from study withdrawal and loss to follow-up, apply correct procedures for each status, and understand the data collection implications.

Document contact attempts systematically, determine when to classify participants as lost to follow-up, navigate the ethical boundary of persistent contact, and manage data quality implications.