EMR to EDC: Why sites and sponsors need CRIO’s EHR/EMR Integration
The new standard in clinical care
Electronic Medical Records
In the past several decades, Electronic Medical Records (EMR) have become standard in clinical care in the United States and many other countries, while Electronic Data Capture (EDC) systems have become standard in global pharmaceutical trials. Naturally, the industry has been highly focused on the tantalizing possibility of integrating EMR into EDC.
However, integration has been difficult, costly, and elusive, often involving long and protracted implementations at the healthcare provider level to connect the EMR to the EDC. These point-to-point integrations are very difficult to scale given the highly fragmented provider market, large volume and velocity of clinical trials. This is exacerbated by the fact that sponsors usually run multi-center studies where sites and investigators are chosen for their expertise on a specific protocol – thus creating a nearly infinite combination of EMR-EDC system integrations to stand up.
The gold standard in clinical research
CRIO’s EMR Integration
CRIO, in partnership with Pluto Health, has solved this problem. Together, the two companies have developed a scalable integration program that permits EMR data to flow into the EDC system using two critical innovations.
- First, EMR data is retrieved through a patient-facing application that puts the patient in control of his/her medical records.
- Second, the EMR data then flows from this patient portal into CRIO’s eSource system for Principal Investigator (PI) interpretation and conversion into source data before transmission into the EDC.
This innovative integration creates a data pipeline that flows multiple EMR systems into a single patient dashboard (Pluto Health), which relays the data to the clinical trial eSource system (CRIO), and then to the sponsor’s EDC system (CRIO or other EDC). The pipeline is bi-directional, in that CRIO will send notifications of the patient’s participation in the trial back to Pluto Health, where the patient can release the notification to his/her providers.
The pipeline compresses several weeks into a few days, creates operational efficiencies for the sites, and improves eligibility and safety oversight for the sponsor. It also facilitates patient centricity by giving them direct access and control over their medical records and ensures bi-directional flow of information between the care and research teams.
To understand the impact of this integration, it’s important to step back and understand how EMR is currently used in clinical trials today.
How EMR is used in clinical trials today
For interventional clinical trials, most clinical research sites utilize their own source system (whether paper-based or electronic, such as CRIO’s) to capture the clinical trial data. They generally do not use the EMR because the EMR is built as a workflow tool for providing care and billing insurance companies and is not optimized for clinical research. CRIO’s survey data confirmed that most sites utilize the EMR as a recruitment tool, not as a source collection tool.
However, EMR systems play a vital role in the data collection process because they house the patient’s incoming clinical history used to determine eligibility. Principal Investigators (PIs) need to reference the EMR to identify past and ongoing medical conditions, medications, procedures, allergies, and other relevant data.
In many trials, site staff utilize the screening period – often 2 to 6 weeks in length – to obtain the medical records. If the clinical trial subject is a patient of theirs, they can simply obtain a study-specific medical release and print out the medical records onsite for insertion into the source binder. If the subject is not a patient, or the subject was seen at a different institution, then site staff must obtain a medical release form and submit it to the relevant provider.
How CRIO’ eConsent-eSource addresses this problem.
Here’s where CRIO’s integrated eConsent-eSource solution comes in. CRIO’s eSource system is an end-to-end workflow tool used by over 2,000 clinical research sites worldwide to manage subjects, schedule visits, and collect source data for remote monitoring. Combined with CRIO’s EDC solutions (CRIO’s own EDC or API to a third party EDC), this infrastructure enables real-time continuous monitoring and eliminates the need for secondary data entry, and hence source data verification.
Often, this process may take weeks, requiring follow-up calls to track the status of the records. When the records do arrive, the subject is no longer onsite for the screening visit, so the Investigator often has to reconcile the medical records against the subject’s self-report through a separate phone call. The records may reveal exclusionary conditions the subject neglected to mention, thus creating a Screen Failure that could have been identified upfront. This means that the subject may have done study-specific procedures that could have been avoided.
Finally, the medical records are not complete or fully accurate. For one thing, a patient may have multiple providers and therefore separate records from multiple institutions. Even within a given institution, several providers will have recorded data over multiple encounters, which creates a cumulative record that is rarely pruned or cleaned. The result is an accumulation of provisional diagnoses, conditions that have self-resolved, medications once prescribed but not actively taken, etc.
Clinical trial protocols usually specify what types of conditions or medications are of special interest. Sometimes, protocols will require over-the-counter medications that may not be part of the prescription record. Or they may specify an inclusion criterion based on a specific diagnosis that isn’t always consistently given in routine care but may be inferred from the medical record along with the PI’s direct observations of the patient.
For this reason, PI interpretation of the medical record is critical. As a result, the medical conditions and medications recorded in the EMR are rarely transcribed into source (and hence the EDC) in a 1:1 manner. Medical conditions listed the EMR may be excluded from the source, or conditions may appear in the source that are not explicitly listed in the EMR (although often consistent and sometimes “mappable”). The best way to think of the EMR is as an input to the source data.
After the subject is randomized, site staff perform ongoing treatment procedures and query the subject about adverse events (AEs) and other medical developments such as changes in medications. Site staff records these changes in the source binder. When the subject reports an AE, staff must once again solicit the underlying medical records so that the Investigator can assess the AE for causality, severity and study treatment implications. This can create yet another laborious workflow to obtain and reconcile records.
The CRIO-Pluto integration
Recent developments have promoted interoperability of medical records and patient access. The FIHR standard has emerged as the platform for interoperability across EMR systems. The 21st Century Cures Act, among others, gives patients the right to receive their medical records without charge. The U.S. is headed towards a world where patients will soon have open, direct control of their medical records on their devices.
Leveraging these developments, Pluto Health, a Research Triangle-based technology spin-off from Duke Clinical Research Institute, has developed a web-based application that lets patients aggregate medical records from multiple providers and then integrates health best practice recommendations. With this application, patients can release their records to other providers.
Critically, the application does not require the patient to enter his/her patient portal url or login credentials; instead, the application queries the health networks within the patient’s local geography to identify a match. Currently, Pluto has over ___ health care providers in their network, with approximately 85% population coverage within the U.S. Pluto Health has already supported the clinical trial industry by being the EMR aggregator for over ___ subjects.
Within CRIO, the clinical research coordinator can initiate a medical records request to the subject with a single click. The subject then receives a text notification requesting release of his or her records to the research investigator. Upon consent, Pluto’s application will aggregate the subject’s medical records and transmit them to CRIO. The entire process can take 15 minutes, so it will be completed while the subject is onsite.
CRIO converts the medical records to a PDF file associated with the subject and alerts the study team. The Investigator can then review the PDF and use it to populate the medical history, concomitant medication and other relevant forms within CRIO. The CRIO file annotation tool allows site staff to redact PHI and otherwise annotate the PDF.
For the next phase, CRIO will enhance this approach even more: EMR data will come in digitally, and the Principal Investigator will have a tool to perform online reconciliation between the EMR records and the source records. He or she will be able to add EMR records directly to source, exclude EMR records with an explanation, or consolidate or rename, indicating map-ability. This will be the final step in a fully digital, end-to-end, auditable data transformation pipeline.
Once the investigator electronically signs the PDF (with annotations), the PDF then becomes part of the study record, ready for remote monitoring by the sponsor or CRO. Thus, CRIO’s workflow ensures that the PI can view and reconcile the medical records prior to “publication” into the record. This protects patient privacy and allows for the critical PI reconciliation described above.
Data from the completed source forms are then transmitted to CRIO’s Reviewer tool, under the integrated CRIO eSource-EDC approach, or sent to the sponsor’s chosen EDC vendor, under the CRIO-EDC API approach. This is the final step of the data pipeline.
CRIO will reciprocate the data flow with the EMR by sending back to PlutoHealth notifications about the patient’s participation in the trial, including completion of study-specific visits. This ensures the patient can notify his/her care team.
CRIO’s innovative EMR integration with Pluto Health leverages the recent trends towards interoperability and patient centricity. It provides a powerful, scalable way to fold electronic medical data into the PI workflow, while respecting patient control over their records. This is the right way to do an EMR-to-EDC integration – not by creating a direct data flow, which would result in duplication of the data quality issues in EMR systems into the EDC – but by creating a pipeline that aggregates data from multiple EMRs into a single record for PI review and reconciliation before entry into the EDC.
This pipeline allows for nearly instantaneous access by the site to the subject’s medical records, thus allowing the PI to complete the medical history reconciliation onsite during the screening visit. Once completed, the reconciled source records are populated in the EDC, and the remote monitor can view the underlying sanitized medical records, with PI annotations, along with the source records. This level of transparency enhances sponsor oversight of quality and patient safety.
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