Before you begin creating and running your own clinical trial in the U.S., you should review the Food and Drug Administration’s (FDA) guidelines for using EHR to record participant information.
With specific suggestions recently released for both providers and institutions to follow, the FDA is preparing official advise and asked for public comments.
Informing yourself about the latest guidelines and requirements is a wise strategy that may protect your clinic from noncompliance. Specifically, the FDA offers a list of technical recommendations and best practices that chiropractors may find valuable for their own clinical trials.
Your software should be interoperable, accurate, and capture data at a high-quality level. For these features, the FDA recommends using a system certified by the Office of the National Coordinator for Health Information Technology (ONC). Certified EHR meet the ONC’s minimum criteria for functionality and security. As such, choosing a certified EHR may help you comply with regulations that impact the use of patient information, whether or not you are using the software for a clinical trial.¹
Non-certified software should still product trial participant data by using rigorous safeguards and data protection features. Your software should restrict unauthorized users and clearly identify authors of data and data changes. With every instance of data entry, the system should track information about changes to participant records. Because the FDA may review your records in the future, your EHR should save and document participant data. You should retain any documentation for as long as you are required to do so.¹
FDA’s best practices
Depending on how you plan to use EHR during your clinical trial, you may find the FDA’s recommended best practices useful. Some of these suggestions include:¹
- EHR Data Sourcing: If you want to extract information from existing EHR records during your trial, the FDA recommends developing a written plan describing how you will obtain and use EHR information. This should attempt to illustrate the transition of data from the original system to the investigation’s system, using a diagram or description. Once you have such a plan in place, you should carefully follow it during the investigation.
- Data Changes: During the course of the trial, any changes to participant data should be carefully logged and included in an audit trail for review later.
- Informed Consent: Trial participants must be made aware of the potential risks and advantages to participating in the trial, including risks to their personal data. You should also make sure they understand and agree with how their data will be used, who has access to their data and other pertinent information.
- Privacy of Data: You should carefully safeguard any participant data you use during your investigation and should be prepared to protect privacy and confidentiality of both participants who finish the trial and those who leave the trial early.
- Maintain Records and Allow Access by the FDA: During and after the end of your investigation, the FDA reserves the right to inspect your records for compliance. Be sure to comply with all documentation requirements during the trial and follow retention recommendations when the trial is over. If you are developing a drug or biological product, you must keep the electronic and paper records for at least two years after you gain approval for marketing the new drug. When you are conducting a medical device trial, these records must generally be kept for two years after the end of the trial or two years after you no longer need the trial data to support a pre-market approval application (whichever is later). For the correct retention period, be sure to verify with the FDA directly, especially if you are not sure how long to keep your records.
Conduct a clinical trial
If you are considering conducting your own clinical trial, be sure to review the FDA’s guidance directly. This may help you maintain compliance and achieve better results from your use of EHR.
¹FDA. “Use of Electronic Health Record Data in Clinical Investigations: Guidance for Industry.” http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM501068.pdf. Published May 2016. Accessed July 2016.