October 2004
An Overview of 'Clinical Data – The Guidelines for Today'
course held on 30th June
I recently attended the 'Clinical Data – the Guidelines for Today' workshop at the Park Crescent Conference Centre in London.
This is a one day workshop aimed at attendees with at least 3 years experience in handling Clinical Data.
The course objectives were well set-out at the beginning of the day – these were:
To emphasise the impact of new legislation and regulations affecting Clinical Data.
To clarify the impact of the Data Privacy Directive on the handling of Clinical Data.
To overview the legislation on e-business.
To discuss the ground rules on which the handling of Clinical Data is based.
Following this, each delegate gave a personal objective of attending the workshop. The morning continued with an introduction and overview of quality and regulatory legislation that affects the handling of clinical data, and how all the pieces e.g. ICH GCP, Data Privacy, CDISC etc fit together.
The next section was on electronic submissions and the status globally of the different ICH regions (US, EU, Japan) with regards to electronic submissions. The experiences of these different regions and comparisons between them were presented. The Common Technical Document (CTD) was also described. The CTD is a document designed to harmonise the organisation and format of technical data for marketing authorisation applications in the 3 ICH regions. The benefits of the CTD were outlined, including resource savings for the industry and faster global registrations for simultaneous submissions.
Following on, the next section described CDISC. This included an exercise on the risks and benefits of using CDISC / standards. For this, the delegates were split into groups to discuss some questions we were given to consider. The groups then re-convened and provided feedback to the whole group.
21CFR part 11, MedDRA, the EU Data Privacy Directive and the EU Clinical Trials Directive were also covered, with further break out groups for exercises on Validation Plans and Preparing for an Inspection.
All topics were equally as interesting and thought-provoking as each other, leading to many in-depth group discussions. The atmosphere in the room was good as everyone was able to contribute to the discussions. The agenda was flexible to allow time for these discussions.
I thoroughly enjoyed the workshop, and found it to be extremely informative and well worth the effort it took to get into Central London on a tube strike day! For those of you interested in attending, the next course is scheduled for 1st December.
Ali Green