Winter 2005/06
An Overview of the 'Successful Implementation of eDiaries for Data Managers' workshop
I recently attended the 'Successful Implementation of eDiaries for Data Managers' workshop held at the Novartis Foundation, London on the 24th November 2004.
The workshop is the second of two modules which makes up the flexible training program 'Building blocks for Successful eDiary Implementation'. The first module is a workshop entitled 'Fundamentals of Implementing Computerised Systems in Clinical Research'. The first module workshop was held the day before and some delegates were attending both modules.
The objectives of the 'Successful Implementation of eDiaries for Data Managers' workshop were:
To introduce the issues and logistics of implementing an eDiary as part of a clinical trial
To describe the step-by-step process for delivering a validated eDiary which meets the business need and fulfils regulatory requirements.
The workshop was run by Andrew Gold and Heather Wells. Andrew opened the day's proceedings with a quiz to test what the delegates already knew about eDiaries. He then followed on with a presentation covering some background information on eDiaries and project life cycle management. Heather gave an informative presentation on gathering, structuring and documenting eDiary requirements. She discussed how these are key to the functional specification and that the user acceptance testing should be performed against these requirements. We had a breakout session, during which, working for our company 'Drugs-R-Us', in teams we had a go at defining our own eDiary requirements for a diary to capture stress symptoms. After this break-out session the whole group reconvened and there was then open discussion on each team's ideas.
"For every stage of the day's agenda, 'keys for success' were highlighted which were helpful reminders for us to keep in mind and there were plenty of opportunities to ask questions"
The next part of the day was dedicated to the process of selecting an eDiary. The instructors gave us a guided tour of the vendor selection process from the client perspective, highlighting key considerations when choosing a vendor but also the importance of managing the relationship with the vendor.
Lunch was provided (the little cakes were lovely, remind me to attend more ACDM workshops in 2006!) and gave everyone a welcomed opportunity to converse and discuss differing approaches to eDiaries. Post lunch there were further presentations. The first covering understanding risks and where risk management fits into the implementation process for a validated eDiary. This section discussed ways of identifying and assessing risks, as well as planning how to manage them. There was also a further group exercise on identifying and categorising risks.
The next part of the day was dedicated to the development of a chosen eDiary solution. The implementation of an eDiary project was split into phases, namely the initiation, development and acceptance phases. For each phase, analysis of the key tasks/activities required was discussed along with the associated documented deliverables of each stage that would ultimately provide evidence that the system is fit for purpose and provide the validation documentation.
The next topic covered was testing, and this included discussion on the purpose and objectives of user acceptance testing (UAT), guidance on the content of the UAT plan, and guidance on test script writing. We were each given an example test script for our reference. The final presentations of the day were on implementing and maintaining the eDiary system. The implementation section highlighted issues from logistics of getting devices to where they need to be, to ensuring data privacy, to helpdesk operation and reporting. The final part of the day focussed on maintaining the validated state of the eDiary system and the importance of change management in maintaining this after the eDiary is released for operation.
For every stage of the day's agenda, 'keys for success' were highlighted which were helpful reminders for us to keep in mind and there were plenty of opportunities to ask questions. The day drew to a close with some people dashing to Heathrow to catch their flights, while others headed off to start their Christmas shopping! I left the workshop thinking how I'd most enjoyed the break-out sessions and particularly the opportunity to discuss and learn with people (and not just DMs) from other companies.
Susie Housley
GSK