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Follow the Project Leader

Debra Jendrasek and Greg Johnson of Chiltern examine a new model of leadership designed to get the best out of EDC studies

Electronic data capture (EDC) has become the norm for new clinical studies. Therefore, it is now critical to understand how EDC changes the way we work. Many papers and presentations have focused on how EDC forces the study team to prepare for set-up earlier than they would have done for a similar study conducted on paper. The EDC start-up timeframe is loaded with deliverables that could have waited weeks, or even months, to be completed in a paperled world. 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 start-up phase and help to prepare the project team for a study that will be successful throughout the process.

In the world of EDC studies, success is defined primarily by utilising the right processes and people, rather than the software system selected. Most EDC vendors would probably disagree with that statement – and indeed there are examples where one system would be suggested over another based on certain project needs, budgetary constraints and other various requirements. However, the minimum requirement of EDC software is to capture, view, edit and manage data from a clinical trial. Most of the EDC tools in the marketplace offer these basic functions, with many having advanced levels of functionality to make the software unique. Therefore, almost any EDC software that is compliant with the regulations would be a workable solution for collecting data for a clinical study.

Software on its own, however, 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 set-up, conduct and close-out of the study have to be articulated clearly, used consistently, well-documented and managed with care. A structured, easy-to-follow methodology needs to be utilised, and someone should be responsible for ensuring that the software is being optimised for all types of users, including CRAs, data management, project management and investigator site staff.

Conducting an EDC study efficiently needs a different style of leadership compared to a paper study. In our organisation, we call the person that oversees EDC study implementation the Technology Project Leader (TPL), but similar titles exist in other companies, such as the Technology Project Manager, Data Management Project Leader, or Data Management Team Leader. The title is not what matters: the key point is the role that this resource plays in the methodology of conducting an EDC study.

For any clinical study, but particularly an EDC study, the start-up phase is critical, and is therefore often the busiest period for all project team members. In particular it is important to consider what resources are needed for the study. Make sure there is someone who can: facilitate the study start-up process; help promote communication across the team functions; pay close attention to the study timelines and deadlines; provoke other staff to pay attention to detail and accomplish EDC-related tasks efficiently.

Many organisations, both sponsor and CRO, would suggest that this role falls primarily to the clinical study leader or project manager (PM). However, the clinical PM has many other responsibilities during study start-up that are focused solely on the clinical aspects of the study. Adding aspects for all technology utilised in a study does not make effective use of the clinical PM’s expertise. For example, the process of setting deadlines and timelines for the build of an EDC study including electronic case report form (eCRF) design, edit check development, user acceptance testing schedules and training delivery plans are critical steps in the start-up phase of any EDC study from a technical perspective. Managing this process requires constant supervision, knowledge of what each team member is required to do in a technology deployment, what function is required and at what time. At the study start-up time, the PM should be more concerned with site selection, site contract negotiations, budget tracking for the study overall and CRA selection, training and management.

The set of tasks listed here provide technical stepping stones towards building an EDC study. The second set of tasks form clinical pathways to creating any clinical trial, and are integral duties of PMs of any study, be it EDC or paper. These are the critical items a hiring manager would look for in a clinical PM. For an EDC study, the PM should retain all overall project management responsibilities, but in order to place the correct focus on the technical aspects listed in the set of steps described, delegating the technical aspects to a colleague is often necessary.

It is important to note that this supporting project management resource (called the TPL for the remainder of the article) does not work as a separate entity focused solely on the EDC aspects of the study. Rather, they are the catalyst for communication across the functions of the study start-up team. They are focused on ensuring all departments working on the study are not working in silos, but are sharing their progress and concerns across the team.

TASK 1: SETTING THE PROJECT PLAN

The first area to focus on for the TPL is creating the EDC project plan. This plan is the blueprint for all tasks that must be carried out and the resources needed in the build and deployment process. At a minimum, it should include the following items:

  • An internal meeting schedule
  • Roles and responsibilities outlined during the build process
  • A roles and responsibilities chart for EDC tasks in the system once it goes live
  • Integration plans for any internal and/or external integrations
  • UAT dates and resources that are assigned
  • An EDC training plan for the project team
  • An EDC training plan for the investigator sites
  • Timelines for all deliverables

This project plan should easily be inserted into the overall study project plan that is managed by the clinical PM; the EDC set-up is just one step in the total study set-up process.

The clinical PM is kept up-to-date on the progress of the EDC build in two ways. The TPL is included in the clinical meetings during the set-up phase of the study and provides weekly updates. Secondly, the clinical PM and their clinical project team are required to provide input data at various critical timepoints during the EDC build process – at the eCRF screen design review, at the edit check specifications, at the user acceptance testing and again, just prior to ‘go-live’. Therefore, the TPL should provide training for the project team early enough so that the clinical team can help make decisions on the study design. This interaction between the TPL and clinical PM will help to ensure that all parties accomplish their go-live goals and will set the clinical team up for success once go-live is reached.

TASK 2: MANAGING TECHNICAL RESOURCES

There are many roles utilised in an EDC study that are typically seen as ‘back-end’ resources. This refers to staff that are typically not client facing and manage their workload by the number of uploads, debugging sessions, critical faults and system errors they encounter in a day. Happiest when talking bits and bytes, back-end resources can combine technical competence with strong leadership in a team environment helping to cross the bridge between clinical and technical jargon, and ensuring the effectiveness of the EDC application.

The TPL is critical in giving the programming team the information needed on clinical issues within the protocol and how they should be translated into the eCRF screens and edit check programming. Most of this information will come from the clinical and data management teams and can often be communicated directly between them and programming, but the TPL adds a timeline and deadline perspective to those conversations. The repercussions and risks associated with these tasks and deadlines need to be addressed and enforced, as any slippage can cause issues to the overall EDC project plan and, in turn, the overall study schedule.

TASK 3: MANAGING AND ENSURING ACCOUNTABILITY

Reaching go-live on time and on budget is sometimes seen as the endpoint of an EDC study. However, we believe that the role of the TPL may be reduced once this is achieved, but their job is not complete. At go-live, several of the building functions are complete but it is at this time that the roles of the CRAs, data management, clinical PM and investigator site staff becomes even more important from an EDC perspective.

Site staff must be trained to use the EDC tool and it is beneficial if they are motivated to achieve results during data collection. CRAs are the best resource to motivate site staff and they, in turn, need proper training in order to assist the sites as needed. The TPL has been involved in the technical development and clinical decisions behind the system, as well as how those decisions have been employed in the EDC technical design, and is therefore well-placed to develop a training programme for both the site and project team staff.

Sometimes we hear in the field that a site does not like using an EDC application. However, nine times out of 10, this is because the training programme employed for that study was either untimely or insufficient for the user; it is rarely because of true defects with the software. The project team needs to understand fully how the sites will enter the data and answer queries, as well as having a grasp of the functions specific to their job role, such as creating queries and source data verification. As go-live is reached and data is entered into the system by the sites, the project team needs to understand the workflow required and complete their review and tasks in a timely fashion. It is at this point that the TPL attends clinical calls to emphasise proper remote monitoring skills. Data collected at the right point, but not monitored regularly, reduces the overall effectiveness of EDC. Project teams will recognise the benefits of the EDC system only if they are using it properly and consistently. In this way, they are able to notice trends and issues and alert the site staff.

CONCLUSION

We have focused on CRAs and monitoring tasks, but the commitment to attain maximum effectiveness with your EDC study needs to reach all staff involved, including (but not limited to) project management, quality assurance, medical monitoring and pharmacovigilance. All of these areas can benefit from the use of EDC if they understand fully how the system works with respect to the information they need and the data being collected.

Three areas were highlighted where the TPL can make a difference in the life of an EDC study. The job requires a person with a skill set that includes technical abilities, time management abilities, supervisory abilities, powerful communication skills and a strong commitment to quality. The TPL can generate positive attitudes across the study team, helping all project staff maximise the effectiveness of the EDC system deployed. Successful EDC studies are not just about the software selected; but also 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 a different model of leadership.


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Debra Jendrasek is the Director of EDC Solutions at Chiltern. In this role she is responsible for all support efforts surrounding clinical trials using EDC and ePRO within Chiltern. Debra attended college in Waltham, MA at Bentley College. After graduating with a Computer Information Systems degree, she joined EDS Systems as a network engineer and software trainer. She switched her role to project management and moved into the clinical research field 15 years ago, merging her technology background with data management principles. Debra is an elected member of the Board of Trustees for the Society for Clinical Data Management.

Greg Johnson is the Director of Biometrics, EU/India, at Chiltern. His responsibilities include the management and oversight of Chiltern’s data management, statistics, statistical programming and medical writing services within the UK, Germany, Spain and India. Greg graduated with a BSc (Hons) in Statistics and Pure Mathematics from Cardiff University, UK and subsequently was awarded a PGCE in Maths and Education at Cardiff University. He entered the pharmaceutical industry in 1990 and performed a wide variety of programming, data management and reporting roles over the next eight years before moving into managerial roles within biometrics. Greg has project managed the selection of EDC software and chaired EDC committees.

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