KAIROS / PRACTICAL RESOURCES
Assess the site.
Beyond the numbers.
Seven indicators for a more useful site performance conversation.
FIELD GUIDE / SITE PERFORMANCE
Look beyond enrollment numbers.
A site assessment needs to consider the right patient population, recruitment quality and reliable, patient-focused execution. These seven indicators offer a starting structure for discussion.
| Indicator | What to assess | Questions to explore |
|---|---|---|
| 01Patient access | Reaches the right patients | Population relevance, referral pathways and realistic access assumptions. |
| 02Recruitment quality | Enrolls eligible participants | Eligibility review, screening documentation and recruitment assumptions. |
| 03Data quality | Accurate, complete, timely data | Record completeness, query handling and timeliness expectations. |
| 04Protocol compliance | Follows protocol and escalates issues | Training, deviation reporting and an agreed escalation route. |
| 05Patient engagement | Supports retention and communication | Visit burden, communication responsibilities and practical support. |
| 06Operational discipline | Consistent visits and documentation | Visit scheduling, source records, handovers and role clarity. |
| 07Technology readiness | Uses trial systems efficiently | System access, training, connectivity and support requirements. |
The overlooked factor: operational burden.
Fragmented systems, duplicated workflows and late information can make site execution harder. An SMO support model should clarify responsibilities, coordinate communication and connect study workflows. Sponsor and investigator responsibilities remain with their respective accountable parties.
An editorial planning guide, not a validated scoring instrument, regulatory standard or claim about Kairos study outcomes.