EMRs and Clinical trials – some questions….and answers

Chris Thorman, from a web site that reviews of electronic health record programs, posted a good article proposing that data from Electronic Medical Records (EMRs) be used for clinical trials, with the following benefits for Physicians considering the purchase of an EMR:

  • Participating in these trials is easier through an EHR than through traditional paper means;
  • Using EHR data solves many of the major problems that clinical trials face; and,
  • Purchasing an EHR creates a big ROI for physicians who decide to participate in clinical trials.

In theory, this sounds great and I found one example: the renowned Mayo clinic’s effort with Centerphase.

I ask the following questions, offer my answers, and welcome comments.

  1. What part of the pre-consent record can a clinical trial investigator access? Only data that is marked ‘non-confidential’ and does not identify the patient.
  2. As a follow on, if the trial investigator is allowed to see pre-consent eligibility or screening attributes only, how can access to the rest of the patient record be suppressed? Implement strict fine grained access controls at the attribute level of a patient record.
  3. Can the investigator access pre-consent data that is marked as confidential? He/she cannot!
  4. Can the patient waive confidentiality or regulatory access restrictions on sensitive pre-consent data? Only with full understanding of the implications
  5. If clinical trial specific data is co-mingled with standard care data, is that data available for insurance/reimbursement purposes? No
  6. As a follow on, what constitutes the “legal medical record” when clinical trial and standard care data are commingled? Only standard care data, acquired by a diagnosis
  7. When a study subject either completes a study or withdraws study consent, does their research-only data remain part of the permanent EMR database? No, it should be erased
  8. Assuming access to trial-specific data is allowed, can a physician who is not a clinical trial investigator, change trial data that they feel are incorrect? No
  9. Should research data be separated from standard clinical care data? Yes
  10. Is there a difference in access rights between standard care data that will be included in the research versus standard care data that will not be included in the research?  No, clinical trial investigators should only have access to data that is included in the research.

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