Two of my colleagues, Chris Thorman from Medical Software Advice and Avis Williams from Solar BioMedical have written some great articles on the connections between clinical trials and electronic health records. The opinions expressed are their own and not necessarily reflective of the views of Diversity HealthWorks or Amri Johnson.
With the changes in health reform, this may be a topic of increasing interest. Thanks to both Chris and Avis for their contribution. Enjoy!
Make it a great day!
Electronic Health Records and Clinical Trials: An Incentive to Innovate
by Chris Thorman
As we wait for the federal government to finalize important sections of the Health Information Technology for Economic and Clinical Health Act (HITECH), there is a lot of talk about the financial incentives for implementing electronic health records (EHR). And understandably so. Practices that implement an EHR under the federal government’s guidelines stand to gain nearly $50,000 in incentives over the next five years. (More)
Electronic Health Records and Clinical Research: A CRA's Perspective
by Avis D. Williams, MSPH, CCRA
A CRA is the term for anyone involved in monitoring clinical trials. One of the main roles of a CRA is to help ensure timely generation and collection of quality research data. With the advent and popularity of electronic clinical trials (eClinical Trials), CRA’s are seeing a gradual increase in the number of clinical research sites (research hospitals, educational institutions, and private medical practices) opting to use electronic medical records as source documents for their clinical trial data. This article describes some of the benefits and drawbacks encountered by CRAs when monitoring sites that use electronic medical records as source documents for their clinical trials.
During a typical monitoring visit at a site that does not utilize electronic medical records, a CRA can expect to be provided with at least two or three thick medical charts that often take up needed space on the small desk provided by the site to work. A paper medical chart may or may not be organized, legible, or complete. Sometimes, the paper medical chart is not available to the CRA during the monitoring visit because the patient is scheduled to have an office visit on the same day as the monitoring visit. All of these factors can potentially hinder the timely collection of important data, or compromise the quality of the data collected by the CRA. Each day’s delay in getting data collected and analyzed for drug approval can cost more than a million dollars to the pharmaceutical or biotechcompany sponsoring the clinical trial. Therefore, timeliness in collecting quality clinical trial data is very important.
However, when a site uses electronic medical records, the CRA experiences a very different scenario. There are no thick medical records to clutter his/her work area. All the medical data are on the computer provided by the site. The electronic medical records tend to be very organized and consistent with the same layout, making it easier to maneuver through the chart and locate the data needed within the chart. The doctor’s progress notes are typed instead of hand written, making the progress notes legible to read. Because the medical records are electronic, more than one person can have access to the record at the same time. The CRA no longer has to wonder if a chart will be available to review during the visit if the patient’s visit happens to be on the same day as the monitoring visit. All of these factors help ensure the timely collection of data, reduce the risk of poor data quality and data analysis delays.
Perhaps one of the more important benefits of having electronic medical records from a CRAs view point is the salvation of data during natural disasters caused by hurricanes, tornadoes, tropical storms, fires, earthquakes, etc. The database that stores the information in the medical record prevents the information from being destroyed during these events. Most southeastern and coastal states in the U.S. are prone to these types of disasters. Clinical research associates can often expect delays in collecting data at these sites during the seasonal weather patterns, but the threat of never collecting the data is eliminated due to the use of electronic databases to store the medical records.
Though the benefits of having electronic medical records are substantial, a few important challenges exist at many sites when monitoring clinical data sourced from electronic medical records is required. These challenges include: 1) non-compliance with 21CFR(code of federal regulations) Part 11; 2) defining the difference between research chart and medical chart; 3) Typos and transcription errors; 4) data entry delays.
Compliance with 21 CFR Part 11 is very important when sites decide to use electronic medical records as source documents for their clinical trials. This federal regulation requires all electronic records to be electronically signed off with a unique user ID and password that is only known by the person creating the document. The regulation further requires each person who has access to a patient’s medical record to be provided with a unique User ID and password as well, including monitors and auditors. CRAs often find that sites and hospitals are using electronic medical records, but they are not 21 CFR compliant, and therefore cannot be deemed as a true electronic medical records facility for clinical trials. In these cases, the CRA is often unable to view the electronic medical record because the site’s computer network is not secure enough to provide the confidentiality needed for other patients’ medical records who are not participating on the clinical trials. The site is still expected to provide printouts of the unsecured information in a paper medical chart along with a statement confirming that all of the printed medical records are complete, and that not documents are knowingly withheld.
A second challenge observed by CRAs is the site’s difficulty in determining the difference between a research chart and a medical chart. Many electronic medical record sites tend to still provide the CRA with a separate paper research chart even though they have electronic medical records. This is often explained by stating that some records are not a part of the medical record, but were obtained from documents developed for the clinical trial, not for the medical record. Therefore, the extra documents were filed in a separate folder outside of the electronic medical record. The challenge encountered here is that a true electronic medical record should contain all documents pertaining to any treatments or clinic visits by that patient. Therefore, the ideal electronic medical system should have the capacity to accept scanned documents from outside sources as well as contain all dictated notes from internal clinic and hospital visits. The purpose for utilizing an electronic system in clinical trials is so that all source data is available and accessible in one working system.
A third challenge experienced at sites with electronic medical records is the increased risk of typos and transcription errors of dates, patient identity and treatment information, cutting and pasting. These errors can compromise data quality, and delay timely data collection if not promptly corrected.
A final challenge experienced by many CRAs working with electronic medical record sites is the have lag time in which patient visits are posted for viewing in the medical record. Many sites have lag times of 48 to 72 hours before the most recent visit can be available for review. Therefore, if a patient’s most recent visit was completed one or two days before the CRA’s visit, then the CRA will be unable to review the data for that patient’s visit because of the lag time required before the patient’s most recent visit is posted, making it difficult to collect the most current data (serious adverse events, adverse events, conmeds, treatment, etc.) for the patient.
Though the above challenges of non-compliance with 21CFR Part 11, defining the difference between research chart and medical chart, typos and transcription errors, and data entry delays are significant, they are fixable and will only enhance the benefits of utilizing electronic records once resolved. Sites that are dedicated to providing stellar electronic medical records are already implementing checks and balances in their system to resolve these challenges. Many of the benefits of easy access, less clutter, data storage during adverse weather patterns, legible progress notes, and consistent chart organization discussed in this article are key drivers of productive monitoring visits that will increase data collection and data quality at the site.