October 2003
As our industry continues to change and technology advances, the changing roles within Data Management are coming to the forefront of issues to face and adapt to. The two following articles are based around the same theme but are from different perspectives: one from a leading CRO in RDC technology, and one from the perspective of a Pharmaceutical company.
The Changing Roles of the CRA and Clinical Data Manager with the Advent of Electronic Data Capture
We are all familiar with the workflow for paper based clinical trials – the interaction between the clinical team and biometrics team and the distinct roles of the Clinical Research Associate (CRA) and data manager. However, with the need to maximise efficiency and keep costs manageable, electronic data capture (EDC) is becoming a viable and exciting option. The effect of this increased uptake of EDC is to change the responsibilities of the study team and alter the workflow we are all used to.
Current roles
Simply, the current workflow means that the databasing and cleaning of CRF data is the responsibility of clinical data management (CDM). Ensuring the protocol required data are captured on the CRF correctly is the responsibility of the CRA along with providing support and guidance to the site. Clinical data management raise queries and the CRA resolves them returning the responses to CDM who then amend the database accordingly. In addition, CDM may be involved in CRF design, medical coding and ultimately freezing the database following completion of all the necessary quality checks (final database QC).
Changing roles
Many of the roles performed by the CRA are unlikely to change with the use of EDC. EDC provides the CRA with a different medium from which to perform Source Data Verification (SDV) and other data checks. However, the CRA provides a vital link between the site staff and the sponsor company and this will remain the same.
This is not necessarily the case for members of CDM. In a purely EDC study, the responsibility for databasing and cleaning the data lies with the site. Any data discrepancies found can be dealt with in real time by the site staff and CRA. The role of the data manager becomes one of eCRF design and database specification (the level of hands on design and database build depends on the system used), defining the validation specifications used to generate discrepancies and the possibility of ad hoc data checks. Flow diagram 1 shows an example of how a study set-up might progress.
EDC has the potential not only to enhance the efficiency of a clinical trial, but also to bring togeter the study team in a positive and fulfilling manner
Once the study is live, the CRA is expected to manage SDV and discrepancy resolution along with other clinically driven tasks. This will require a degree of training in the use of the EDC system and how the process of SDV and discrepancy resolution works. In addition, the CRA must be able to scrutinise what has been entered to maximise the quality of the data.
Within CDM, once an EDC study is up and running, our role may be one of consultancy for the site on data issues or we may be asked to carry out data checks using the EDC system that are better suited to the way we work. For example, cross panel checks such as reconciliation of medications with adverse events. Of course, these kinds of checks could also be performed by the CRA. Medical coding will be performed away from the site, either by CDM or a specialist coding team. Any discrepancies will then be resolved within the system and the coding team notified. Flow diagram 2 shows an example of how the processing part of the study might progress.
The changing approach to study management
The way EDC trials are managed will have to evolve alongside the technology and processing. The amount of time spent setting up a study will undoubtedly increase whereas the time and resource spent processing a study should decrease. This shift in time and resource must be taken into account when planning an EDC study. Overall, the time spent on a given clinical trial should be reduced by EDC, but careful planning and an understanding of the requirements are essential.
The main areas to consider are:
a. Training of CRAs/data managers and site staff in the use of the system and how and where they gain technical help. The EDC process of SDV, discrepancy resolution and information propagation should be clearly defined.
b. Provision of laptops and online access in order to store the entered data. This can be done purely online or offline with online connection required to download the data.
c. The CDM team will be heavily involved with the study team in getting the study set-up for processing.
d. The sponsor will have to become familiar with their technical responsibilities such as eCRF design review and user acceptance testing of the system.
The prospect of an EDC study is certainly an exciting one. There will be challenges for all of us in adapting to the changing workflow. As data managers, we will need to develop our skills further in order to provide the best service to our clinical colleagues. However, EDC has the potential not only to enhance the efficiency of a clinical trial but also, to bring together the study team in a positive and fulfilling manner.
Emma Banks and Comell Nandha