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 as 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 1 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 utopian vision that is ‘e-Clinical’ where data is recorded once and is available directly in the database?
There has been a recent question raised 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 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 a number of 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 to 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 to which it was originally captured. Surely, there would be greater buy-in from sites if they entered data directly in to 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 almost 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 recognised 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 5-10 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 Electronic Medical Records. 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 one or more hypothesis. An Electronic Medical Record 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 the electronic source data in to an Electronic Medical Record 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 was no transcription of source data from patient records in to 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 be 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; remote access to the source. Monitoring could then concentrate on other tasks such as drug accountability, site document review, issue resolution and site management. Potentially, the frequency of monitoring visits could therefore be reduced.
In conclusion, for certain types of study where primary electronic source records can be merged with other electronic primary source records such as electronic ECG, and providing that all GCP guidelines are adhered to, then 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.
Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Volume 3C Efficacy, Rules Governing Medicinal Products in the European Union.