The U.S. Food and Drug Administration (FDA) issued a guidance in September 2013 that provides recommendations to Contract Research Organizations (CROs), clinical investigators, sponsors and others who are involved in capturing, reviewing and maintaining electronic source data in FDA-regulated clinical investigations. This is with a view to streamline and modernize clinical trials. The guidance is intended to be used along with the FDA guidance for industry on Computerized Systems Used in Clinical Investigations, or simply, the computerized systems guidance. The guidance is intended to ensure the quality, integrity, reliability and traceability of data for clinical trial from electronic source to electronic regulatory submission.
It addresses the source data in clinical investigations used to fill up the pre-defined fields in an electronic case report form (eCRF) as per the clinical trial protocol. The following topics regarding electronic source data are discussed in the guidance.
Identifying and specifying authorized source data generators
Creating data element identifiers to facilitate audit trail examination by FDA, sponsors and other authorized parties
Methods to capture source data into the eCRF manually or electronically
The responsibilities of clinical investigators regarding the review and retention of electronic data
Use and description of computerized systems in clinical trials
Use of eCRF
According to the regulatory authority, an electronic record is a combination of text, graphics, data, audio, pictorial or other information represented in digital format which is created, modified, maintained, archived, retrieved or distributed by a computer system and eCRF is an example of such a record. To be more specific, eCRF is an auditable electronic record of information usually reported to the sponsor or other regulatory body pertaining to the clinical investigation on each trial subject as per the clinical investigation protocol. Using eCRF, the clinical investigation data or source data can be captured, reviewed, analyzed and reported systematically.
The source data can be entered into eCRF through any of the methods given below.
Entered directly by an authorized data originator (for instance, clinical investigators, consulting services)
Transmitted automatically from devices or instruments (for example, blood pressure monitoring device)
Transcribed from paper or electronic sources
Transmitted directly from Electronic Health Records (EHRs)
Transmitted from Patient-Reported Outcome (PRO) Instruments
Capturing source data electronically and transmitting it to eCRF offers the following benefits:
Supports the entry of source data wherever appropriate during a subject’s visit, which will eliminate unnecessary duplication of data and minimize transcription errors
No need to transcribe the source data before entering into an eCRF
Encourages remote monitoring of data
Facilitates real-time access for review by sponsor and FDA
Promotes the collection of accurate and complete data
Role of EHR/EMR Transcription Service
The source data consists of all information in original records and certified copies of original records of clinical findings, observations or other activities related to the investigation, which is imperative for reconstructing and evaluating the investigation. It is crucial for both FDA and the sponsor to access source data for review and inspection during clinical investigations to ensure the protection of the rights, welfare, and safety of human subjects and the quality and integrity of investigation data. The regulator insists that the source data need to be attributable, legible, contemporaneous, original and accurate (ALCOA) and strictly follow the regulatory requirements for record keeping.
The electronic transmission of source data to eCRF will be beneficial only if the data has these features. If the electronic instruments are of high quality, there is no need to worry about the accuracy. However, it is very important to ensure the data feeds entered into EHR/EMR systems are accurate. There is where providers may need EHR/EMR transcription service.
Usually, data is entered into an EMR system by choosing variables in pre-structured point and click templates. The output generated from these templates is too identical and lacks individuality for each patient. The templates must be customized according to the physician’s requirement, which can be very expensive. Moreover, it is difficult for a provider to capture the complete patient encounter on an EMR system in front of a patient.
On the other hand, a professional medical transcription company can provide diverse EHR and EMR solutions to meet the dictation and transcription needs of physicians, clinics and hospitals. These solutions include:
HL7 interface that simplifies the process of capturing patient data from HIS/CIS/RIS systems and returning the transcripts securely to the provider’s HIS/EHR/ or RIS system.
Direct connection tool such as VPN that allows real-time transcription into the provider’s system
Delivering the transcripts directly to specified folders in the provider’s network according to individual scheduling preferences.
The FDA guidance implies that the use of Electronic Health Records and Electronic Data Capture (EDC) systems in clinical trials is critical and requires much attention. When source data is captured electronically and transmitted to the eCRF, unnecessary duplication of data can be avoided. Other benefits include real time access to data for review purposes, accurate and complete data and remote monitoring of data. This guidance on electronic source data pertaining to clinical investigations is expected to ensure traceability and transparency.