Do you remember where you were when you heard the slogan, “Cleaner data faster”? That was the promise of Electronic Data Capture (EDC). A brave new world. Those of us at the forefront of EDC — or Remote Data Entry, which is what it really was — may well remember the change resistance demonstrated by various stakeholders combined with the enthusiasm of early adopters. EDC is now widely embraced and is often the de facto method of data capture in clinical trials, including, to a degree, Phase I studies. How far can EDC expand? We already have robust processes and services in Electronic Patient Recorded Outcomes (ePRO) and this area has combined well with certain types of EDC studies. The question is, how far are we from the utopia that is ‘e-Clinical’ where data is recorded once and is available directly in the database?

A question has arisen recently in the industry of when it comes to capturing clinical data: Who is responsible for reviewing the data in an eCRF against the source data? What if we didn’t have electronic care report form (eCRF) data — just source data? What if the data recorded in source data was transferred to the database in real time?

The initial use of Remote Data Entry systems saw some sites receiving a number of sponsor-provisioned laptops if they were involved in multiple studies. This was certainly inefficient in terms of hardware space. Fortunately, those days are gone, but sites still need to log in to various online systems if they are conducting several studies in parallel. Also, EDC studies (i.e. electronic CRFs) are arguably a contemporary version of a paper CRF, with a paper source document. The assessment is recorded in the source at site, entered in an online EDC application and then verified by a monitor. It is rare that any development of an eCRF involves the ultimate end users, the Investigator and study nurse, in the end-user testing. Therefore, sites often are faced with entering data in a different way than that in which it was originally captured. Surely, there would be greater buy-in from sites if they entered data directly into a repository that replicates (to a large degree) the format of the current paper source or Electronic Medical Record (EMR). If this could be accessed and utilized directly at the patient bedside then data could be accessed in near-real time by the sponsor.

We have seen the rise in standards such as those instigated by CDISC (Clinical Data Interchange Standards Consortium), which has lead to increases in data quality (through the use of consistent and recognized variable naming and form structure) and consequently to greater adoption by study teams and further requirements around increased data quality. We have also seen these electronic data standards move in to other areas of data capture during the last five to 10 years. Thus, we have seen the steady adoption of Electronic Patient Recorded Outcomes (ePRO) as their use negates late patient data entry and allows for reasonably continuous access to patient data via online tools.

We have also seen the integration of data that negates reconciliation. If data that is already captured in an IVRS or IWRS system is used to populate fields in an eCRF, such as demographics (sex, age), then this can reduce entry error and reconciliation. It can also provide a mechanism, through integration, that ‘halts’ data entry until the patient is acknowledged as randomized within the system, thus negating erroneous entry of screen failures.

One potentially difficult integration is that of electronic source records with EMRs. The reason for this is because there are two distinct objectives in terms of the data captured. A trial captures data based on a protocol and is captured in the system, as previously discussed, designed around a CRF in order to prove or disprove a hypothesis (or hypotheses). An EMR is used to record the patient’s medical history and care during a specific length of time. If clinical patient data was collected only as electronic source data, it would be possible to integrate that data into an EMR using healthcare interoperability standards such as Health Level Seven (HL7) data export or, alternatively, printing the electronic source data and add it to the patient’s medical record.

The harnessing of all electronic data could move a trial towards the lines of being truly eClinical rather than a disparate group of data repositories joined together purely by a common protocol. However, there are still questions over the legitimacy of data as it is transferred from one location to another through human data entry. With Source Data Verification (SDV) and data management review through edit checks and listings, transcription errors are found throughout the conduct of a trial. If there were no transcription of source data from patient records into the CRF, then there would be no requirement to use checks to monitor transcription error. There would still be a requirement to manage transcription error but this would be at the point of initial entry (checks for future dates, ranges checks, etc.). This approach could be harnessed in certain types of trials, where there is no other paper source collection, such as local lab records or paper ECG, as these would comprise additional primary source data that would require entry.

Finally, the economic constraints of a study mean that we have already seen attempts to reduce the cost impact of monitoring visits by increasing central or remote monitoring and targeted SDV. Even so, SDV contributes around 50% of a monitoring visit. The current model of using paper documents, or EMR, at site to record patient source data means that in order for it to be monitored, the monitor must be able to access the source documents. If electronic source records were used, there would be no reconciliation between the source data and the CRF data, but there would be remote access to the source. Monitoring could then concentrate on other tasks such as drug accountability, site document review, issue resolution and site management. Thus the frequency of monitoring visits could potentially be reduced.

There are certain cases where electronic source records can prove to be an efficient method of collecting data that allows clinical and safety review shortly after the clinical assessment. Efficiencies and cost savings can be garnered through the reduction of SDV, CRF design and edit check validation creation and programming. 

Sources

• http://www.clinicalink.com/downloads/pdf/ESR-Fulfilling-the-Promise-of-EDC.pdf
• http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004385.pdf
• http://www.cdisc.org/stuff/contentmgr/files/0/2f6eca8f0df7caac5bbd4fadfd76d575/miscdocs/esdi.pdf
• Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Volume 3C Efficacy, Rules Governing Medicinal Products in the European Union.