HCO Minimum Requirements
(after site selection of sponsors)

Assessment of relevant site processes and technology systems to ensure readiness for integration with an eSource vendor or existing vendor compliant with consortium requirements and approved by the Sponsor. Long-term considerations may include the development of a maturity matrix for sites and middleware certification, potentially facilitated through i~HD.

Considering target minimum requirements:

  1. Strong HCO senior support from both IT department and Clinical Research Staff (HCO EHR eSource Champion) in place.
  2. Willingness to commit dedicated resources in EHR and clinical research.
  3. Structured data entry into electronic EHR, ensuring:
  4. complying with published guidance to capture data provenance* and have robust audited version tracking
  5. availability in structured and coded form of Vital Signs (VS) and Local Lab (LL) data
  6. Utilization of a certified EHR system, meeting regional requirements such as ONC
  7. Adoption of FHIR®.
  8. Selection of a middleware solution needs to comply with the i-HD middleware requirements.
  9. Utilization of common clinical coding ontologies such as LOINC and/or SNOMED.

*to ISO 18308, ALCOA and EMA reference

Recommendations:

  • Expanding structured data entry into EHR such as Medications and Adverse Events (AE) and plans for incorporating research FHIR® resources into the system roadmap.
  • Sites that meet requirements 1 and 2 are welcome to collaborate with i-HD task force members to develop the others.
i~HD