GCP Foundations for New Research Coordinators

Source documentation is the evidentiary backbone of every clinical trial. This session teaches coordinators how to design and maintain source documents that are complete, accurate, and audit-ready. Participants learn the ALCOA+ principles of data integrity — Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available — and how to apply each principle to the documents they create and maintain.

Practical coverage includes visit window management and scheduling strategies that minimize protocol deviations, source document design principles that make data extraction efficient and error-resistant, and proper documentation of protocol deviations including how to identify, categorize, report, and implement corrective actions for deviations. The session also covers screen failure documentation — an often-overlooked area that requires careful handling to satisfy both regulatory requirements and sponsor data collection needs.

Patient safety is the paramount concern in clinical research, and adverse event reporting is the primary mechanism through which safety signals are identified and communicated. This session teaches coordinators the critical distinctions between adverse events (AEs) and serious adverse events (SAEs), including the four criteria that define seriousness: death, life-threatening, hospitalization or prolongation of existing hospitalization, and persistent or significant disability or incapacity.

Participants learn to grade adverse event severity using the Common Terminology Criteria for Adverse Events (CTCAE) scale and to understand the difference between severity grading and seriousness classification — a distinction that frequently causes confusion among new coordinators. The session covers causality assessment frameworks, helping coordinators understand how investigators determine the relationship between an adverse event and the study intervention.

Reporting timelines are covered in detail, including the 24-hour SAE reporting window, follow-up reporting requirements, and the coordinator’s role in gathering the clinical information investigators need to complete safety reports accurately and on time. Documentation requirements for adverse events are emphasized throughout, with examples of both compliant and non-compliant AE documentation to illustrate best practices and common pitfalls.

Clinical research associates (monitors) are a coordinator’s most frequent external contact, and the relationship between coordinators and monitors significantly impacts site performance and trial quality. This session teaches coordinators what monitors look for during routine monitoring visits, including source data verification priorities, regulatory document review focus areas, and the types of findings that escalate from observations to formal findings.

Participants learn how to prepare for monitoring visits effectively — organizing source documents for efficient review, ensuring regulatory binders are current, pre-reviewing data for obvious discrepancies, and having enrollment and safety information readily accessible. The source data verification process is explained from both the monitor’s and coordinator’s perspectives, helping coordinators understand what constitutes adequate source support for CRF data.

Query resolution workflows are covered, including how to respond to data queries efficiently, how to document corrections properly using single-line strikethroughs with date, initials, and reason for change, and how to prevent recurring queries through improved upstream documentation practices. The session concludes with guidance on building productive monitor relationships based on professionalism, transparency, and shared commitment to data quality and participant safety.

The final session of the workshop brings together everything participants have learned over two days into a comprehensive, hands-on practical exercise. Working in small teams, participants work through a simulated study startup using a realistic mock protocol, performing the tasks a coordinator would complete when activating a new study at their site.

The exercise includes assembling a complete set of regulatory documents for the mock study, including the protocol signature page, FDA 1572, financial disclosure forms, delegation log, training log, and IRB approval documentation. Participants conduct a guided consent form review, identifying elements that meet regulatory requirements and areas that would benefit from revision. Each team creates a study visit checklist based on the mock protocol’s visit schedule, identifying required assessments, procedures, and documentation at each visit.

The exercise concludes with an enrollment readiness assessment where each team presents their findings to the group and receives feedback from the instructor and peers. This collaborative exercise reinforces the connection between regulatory knowledge and operational execution, giving participants practical experience they can apply immediately upon returning to their sites.