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Problem and Target Outcome
- Some data necessary for trials is in the EHR, but not expressed in a standard, structured way (e.g., they are in Notes).
- Any data necessary for trials and already in the EHR must be manually re-entered into case report forms (CRFs).
- Investigators leverage clinical treatment data captured in the EHR to derive and/or compute clinical trial endpoints.
Eliminates (or at least reduces) the need for manual entry of duplicate data into case report forms (CRFs).
If the trial requires data stored outside the EHR (e.g., patient-reported outcomes, laboratory data, etc.), ideally this data can also be expressed in a standard, computable manner via mCODE and extensions.
|Actor||Investigators, trial sponsors, clinicians, patients|
Obtain and/or derive clinical trial endpoints from EHR data rather than by traditional clinical trial data collection methods (i.e., by manually entering data into separate case report forms).
Investigators and/or trial sponsors want to conduct a clinical trial for a new oncology treatment.
Streamlined, less costly, more inclusive clinical research overall as a result of:
3A. Sites may store required data elements in non-EHR systems; ideally, these data can be expressed as mCODE/extensions regardless of where they are housed. However, the need to extract and share data from disparate sources may add complexity to the process.
Definition of scope will need to consider that data available in EHR vs. other systems will vary from site to site.
ICAREdata Study is testing the feasibility of this concept in phases; the current draft implementation guide includes . To support ICAREdata, an FHIR Implementation Guide was developed that adds cancer disease status and cancer treatment plan change to the base mCODE data elements.
Extending mCODE with additional data elements beyond disease status and treatment change could prepare us to broaden clinical research applications:
Conference Call Information
Use Case Team
|Domain Lead||Ammu Irivinti||The MITRE Corporation|