Clinical Research Coordinator Intake Form

The Clinical Research Coordinator Intake Form is a screening and enrollment tool used to evaluate potential participants for clinical research studies. Research coordinators are responsible for identifying qualified candidates, verifying eligibility against protocol-specific inclusion and exclusion criteria, and onboarding participants into studies with complete and accurate documentation. This form standardizes the initial data collection process so that coordinators can efficiently gather the information needed to determine whether a prospective participant is a suitable match for one or more active research protocols. It serves as the first point of formal documentation in the participant's research file.

The form collects participant demographics, contact information, and referral source details to track recruitment channel effectiveness. Medical history sections capture current diagnoses, chronic conditions, surgical history, and active symptoms that coordinators evaluate against study eligibility criteria. A comprehensive medication list with dosages and frequencies supports concomitant medication review, which is critical for studies with drug interaction exclusions. The form records whether the individual has participated in previous research studies, including study type, dates of participation, and any adverse events experienced. Protocol-specific screening questions can be customized per study to address unique eligibility requirements. Availability fields document the participant's schedule constraints for study visits, which helps coordinators assess whether the individual can realistically comply with the visit schedule required by the protocol.

This form is used at academic medical centers, contract research organizations (CROs), pharmaceutical company research sites, hospital-based clinical trial units, and independent research facilities conducting Phase I through Phase IV studies. It supports compliance with Good Clinical Practice (GCP) guidelines established by the International Council for Harmonisation (ICH), which require that screening procedures be documented thoroughly and that only eligible participants are enrolled. The structured format also satisfies FDA regulatory requirements for source documentation and helps sites prepare for sponsor monitoring visits and regulatory audits. By capturing consistent, complete screening data from the outset, the form reduces protocol deviations related to enrollment errors and improves the overall quality and efficiency of the clinical trial recruitment process.