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Hot Topic Discussions

Hot Topics from ACDM

About ACDM Hot Topics

These are held online as ‘discussions’ focussing on a topic in Data Management. They are free for ACDM members (small fee for Non-Members).

As they are ‘discussions’ they are different to webinars and no presentation slides are prepared.

A person is identified to lead each session, together with a Chair, they drive the discussion with those who join call. Sometimes the sessions are recorded and/or summarised and shared with ACDM members.

Interplay between GCP, privacy and GDPR

Date: February 19, 2021
Type: Hot Topic
Session Lead: Bertrand Le Bourgeois
Location: Online 12:00 – 13:00 UK Time
Learning Objectives:

As Clinical data managers , we work in a regulated industry and we are a key element in the compliance process of our organisations to the regulations and guidelines in place.

In addition to Clinical Good Practices (i.e. ICH E6) and other ICH guidelines, most countries in Europe have adopted data privacy laws since many years, and in May 2018, the General Data Protection Regulation (GDPR) came into force in the European Union.

12 other countries outside Europe have privacy laws in adequation with GDPR and GDPR is becoming the gold standard to protect the private life of citizens.

The Healthcare and Life Sciences industries have not been waiting for the GDPR to protect the rights of patients, and many measures have been in place for years already with the Code of Nuremberg in 1947 and the Convention of Helsinki in 1964, just to name a few.

Our industry is probably the most advanced in that matter.

Does this mean that all principles of the GDPR are already included in the regulations and guidelines in our sector?

No, there are new aspects that every clinical data manager needs to know in order to guarantee that the data management process is compliant, for example:

  • Is it ok to keep past clinical studies in the live data base of our eCRF forever?
  • Is it ok to reuse past clinical data for a registry for example?
  • Can we run a meta-analysis across our data warehouse on a given indication for example?
  • What are the requirements for doing such processes?
  • When and how do we need to re-inform patients before starting the process?
  • When do we need to get their consent again?
  • Which new things do we need to check when auditing a sub-contractor?
  • What if the eCRF database is hosted in the US: is it still compliant? What do we need to put in place before transferring the encoded patient data?
  • Medical research laws state that the sponsor is legally responsible for anything relating to a clinical study: why do all sub-contractors now share responsibility?

You will get answers to these questions during the Hot Topic presentation and interactive discussion.

Who is this suitable for?

ACDM members and non-members who would like to join an open discussion concerning a Hot Topic in Data Management

Outline content
Price (Member)  £0 (+VAT)
Price (Non-Member)  £50 (+VAT)
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