In an attempt to help sponsors, clinical investigators, CROs (Contract Research Organizations) and IRBs (Institutional Review Boards), the new guidance on EHR data clearly defines the use of the EHR data in FDA-regulated clinical trials.
What is an Electronic Health Record (EHR)?
As FDA defines, EHRs are “electronic platforms that contain individual Electronic health records for patients and are maintained by health care organizations and institutions.” It includes following information associated with patients:
- medical history
- diagnoses
- treatment plans
- immunization dates
- allergies
- radiology images
- pharmacy records and laboratory and test results
What does the guidance recommend?
Decoding the actual guidance, we could find out the recommendations as:
- Deciding whether and how to use EHRs as a source of data in clinical trial investigations
- Using EHRs that are interoperable with electronic systems supporting clinical trial investigations
- Ensuring the quality and the integrity of EHR data that are collected and used as electronic source data in clinical trial investigations
- Ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meets FDA’s inspection, recordkeeping, and record retention requirements
The Do’s and Don’ts of EHR Data
The FDA recommends EHR Data to be used in prospective Clinical Investigations of:
- Human drugs and biological products,
- Medical devices, and
- Combination products
However, the FDA states that the recommendations do NOT apply to the use of EHR data in cases of:
- Post-marketing studies related to observational pharmacoepidemiologics for assessing the risk
- Data being used as recruitment tool for end-to-end clinical investigations
In a fast-paced world of Regulatory environment there might be chances companies have to go through a number of clinical Investigations in order to bring in the product improvements. In such scenarios, the use of EHR brings in the opportunity to maintain data accuracy, patient safety, and clinical trial efficiency. As quoted by the FDA, EHRs enable investigators and personnel involved in the clinical studies to analyze, combine, aggregate data from disparate sources. The electronic platforms not only provide real-time access to essential clinical data but also helps to facilitate post-trial follow up. But how secured is your electronic trial solution is the question.
In case you are looking for a secured eTMF solution that can handle all your clinical trial data Freyr offers a robust eTMF solution which is ready-to-use, simple and efficient.
