EMR-Based Clinical Trial Feasibility: Turn Practice Data Into Better Questions

Begin with a clinical question, not an export

An existing EMR can help a medical practice understand where research may fit. The first useful step is to define the question the team is trying to answer. A search for everyone with a broad diagnosis can reveal general access. A protocol-specific question needs more detail about the condition, treatment history, timing, and information available for review.

Work with the physician and appropriate practice staff to identify which fields are meaningful and how consistently they are maintained. Diagnosis codes, medication lists, notes, test results, and external records can tell different parts of the story. Understanding those differences helps the team interpret a result rather than treating the output as self-explanatory.

Describe the limits of the available information

A missing field does not necessarily establish the absence of a condition or treatment. The information may sit in a note, an outside record, a different system, or a visit that has not been reviewed. A feasibility assessment should identify these gaps before drawing a conclusion about the potential population.

Separate criteria the team can explore from those requiring records, clinical interpretation, or formal study assessment. Record how the search was defined and when it was performed. This gives the sponsor a clearer view of what the result supports and helps the site repeat or refine the review when the protocol changes.

Use information within an agreed access framework

Before reviewing or moving patient information, the practice and research team need to understand who is authorized to access it, for what purpose, and through which approved process. The practical workflow should address where information is viewed, how findings are communicated, and what stays within the practice’s existing environment.

FDA’s guidance on electronic systems and records discusses trustworthy and reliable clinical-investigation records. A useful operational lesson is to treat the system and its use as part of the workflow. A convenient export is not automatically the appropriate way to answer a feasibility question.

• Define the population question and the fields used to explore it.
• Check how diagnosis, medication, and test information are maintained.
• Mark unknown criteria separately from confirmed findings.
• Agree on authorized access, review responsibilities, and the next clinical assessment.

Connect the result with the patient pathway

A population review becomes more useful when the team explains what happens next. Which records need checking? Who reviews the clinical context? How would a patient be approached? What information is needed before arranging screening? These questions reveal the work between an EMR signal and a possible participant.

Our feasibility process connects patient access with investigator fit and operating capacity. WGR’s technology-supported approach helps organize context and assigned follow-up. It does not turn a search result into confirmed eligibility or replace the judgment of the appropriate clinical team.

WCR's connected patient-access pathways provide a related example of bringing practice records, physician referrals, and recruitment follow-up into one working process.

Make the review useful beyond one questionnaire

An initial EMR assessment can help a practice identify the disease populations it understands well, information gaps worth improving, and the types of studies that may fit. Keep those insights separate from promises about a future protocol. A different study can require a different population definition and another review.

For practices considering research, this work can inform a more focused partnership discussion. WGR helps connect existing care relationships with study opportunities, central operations, and mentorship. Explore bringing research into your practice and our discussion of patient access and enrollment forecasts to see how those pieces fit together.

Keep a useful record of the review

Create a concise search note that describes the clinical question, the information sources considered, the broad review method, the date, and the limitations that matter to interpretation. Avoid placing identifiable patient detail into a general feasibility report when a summary can answer the question. The practice’s agreed access and information-handling process should guide the work.

Use the note when the sponsor asks a follow-up question or a new protocol changes the target population. The team can see which assumptions need revisiting instead of treating every request as a completely new search. Over time, this disciplined review can also show where practice information is strong and where additional clinical context is consistently needed.