EDC: Looking beyond the software
pharmafile | August 4, 2010 | Feature | Research and Development |Â Â EDC, chilternÂ
Electronic data capture (EDC) has become the norm for clinical studies. In an EDC study, most of the deliverables are now due long before the first patient is enrolled. The people and tools that are used to oversee these deliverables and deadlines are major contributors to the success of the study startup phase and help to ready the project team for a study that will be successful in duration.
In the world of EDC studies, success is defined more by utilising the right processes and people. The minimum requirement of EDC software is to capture, view, edit and manage data from a clinical trial. Most of the EDC tools offer these basic functions; therefore, almost any EDC software that is regulatory compliant would be a workable solution.
Software on its own will not make the study a success. The team wrapped around the system needs to be available, interested and accountable. The processes used during the setup, conduct and closeout of the study have to be clearly articulated, consistently used, well documented and properly managed.
A structured, easy to follow methodology needs to be utilised and someone should be responsible to ensure the software is being optimised for all types of users. Conducting an EDC study efficiently needs a different style of leadership compared to a paper study. In our organisation, we call this person the Technology Project Leader (TPL).
Task 1: Setting the plan
The first area of focus for the TPL is creating the EDC Project Plan. This plan is the blueprint for all steps, tasks and resources that will be needed and followed in the entire build and deployment process. This project plan should easily be inserted into the overall study project plan managed by the clinical PM, as the EDC setup is just one step in the total setup process.
Task 2: Managing technical resources
A resource that can combine technical competence with strong leadership in a team environment will help to cross the bridge between clinical jargon and technical jargon. The TPL is the conduit to transfer the proper information and the ringmaster to motivate and challenge the team to meet (or beat) the deadlines for the project.
Task 3: Managing and ensuring accountability
At Go-Live, several of the building functions are complete but it is at this time that the role of the CRAs, data management, clinical PM and investigator site staff become even more important. Project teams will recognise the benefits of the EDC system only if they are using it properly and consistently. At this time the TPL must emphasise proper remote monitoring skills.
The role of the TPL is a varied one. The job requires a skill set that includes technical abilities, time management abilities, supervisory abilities, powerful communication skills and a strong commitment to quality.
The TPL is a driving force to generate positive attitudes across the study team, helping all project staff maximise the effectiveness of the EDC system deployed.
Successful EDC studies are about the process wrapped around the software, the people that manage that process and additional specialised support for the project manager. Successful EDC studies require this different model of leadership.
Debra Jendrasek and Greg Johnson work for contract research organisation Chiltern. For further information visit: www.chiltern.com.
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