Data Matters eNewsletter
Welcome to the latest edition of the ACDM Newsletter. Previously issued in a magazine format we have now moved on to an electronic format issued on a more frequent basis. Read below for news and announcements.
ACDM Update on the first half of 2019
I wanted to take this opportunity to update you on some of the activities that ACDM have been undertaking in the first half of 2019. We had set out some aims and goals at the start of the year that were both ambitious and challenging and our team have produced some excellent results so far of which I am very proud.
So starting with ACDM Training, we wanted to begin building an online presence to allow members around the globe to partake in training online, no small task, however having accepted the role, Tracie Lavery has successfully taken on the running and organisation of the Training Committee. Tracie has given the team of volunteers a new impetus, a new strategy and released our first online training course developed by Nicola Kemble at Delegant. Over the coming months, new courses will be added to Training area of our website.
ACDM19 was held in Amsterdam and was bigger and better than 2018. The Conference Committee and Delegant provided the perfect blend of networking and education with some excellent thought-provoking presentations. We achieved an increased number of attendees, exhibitors and sponsorship whose support we are very grateful for. We are looking forward to ACDM20 in Dublin under the direction of Nickie Griffiths.
Communications via our digital newsletter (DataMatters) have been sent out on a regular basis, in a new improved format that seems to be attracting attention and making a positive impact. Along with a greater visibility via social media, the team (Ali Roskell, Hanneke Lankheet and Delegant) continue to find better innovative ways to communicate and connect with professionals working with clinical data globally.
Our recent success with Hot Topic discussions on ‘How virtual clinical trials impact data management’ and ‘Why the world needs machine readable medical research data’, has encouraged us to line up another three for members to participate in. New DMEGs (Data Management Expert Groups) have now been established and both the Clinical Trials Unit and eDigital groups are up and running (run by Aiden Lonergan and Lauren Ellis-Hill respectively) with another two on the way. Membership has steadily increased thanks to our new company membership option, with an aim to attract members via a new strategy for the Asia Pacific region with help from Board Member Paul Donnelly. We are also pleased to introduce Irina Sargsyan from Business & Decision as our new Board Member who volunteered to help us with bundles of enthusiasm. And behind the scenes, our finances overseen by Jo Marshall look set to deliver a balanced budget, with the investments occurring this year being offset by the success of the training and conference programmes.
As you can see, this group of Volunteers have already produced some remarkable changes in the first half of 2019. They and their companies provide immense support to provide these services to the ACDM membership, so I urge you too, to encourage fellow professionals working with clinical data to get involved in whatever way you can and help drive the association forward.
Ian Pinto, Chair of ACDM
The Conference Committee held their first meeting to start preparations for ACDM20.
The Call for Abstracts is being updated and this will be released by 5th July.
The Marketing Pack has been updated and there are two new opportunities being offered for ACDM20. Bookings for Sponsorship and Exhibition Stands will open shortly. If you want to be the first to find out when these are available you can register for Updates at the bottom of this page.
ACDM’s CTU Expert Group first meeting was held on 26th April. The meeting was to cover the challenges that CTUs face when adopting a new system.
The group listened to a presentation by Manchester CTU on it’s experience implementing a new EDC system. It covered the approach MCTU took in validating and implementing the system, the issues they faced and what they would do differently in the future. The group then shared their own experiences in adopting and implementing new systems.
The next meeting will be scheduled shortly and is set to discuss the group’s experience in adopting and implementing the NHS Digital DSP toolkit.
If you would like to find out more or join one of the groups click here for further details.
ACDM’s eDigital Expert Group kicked off their first meeting on 4th June with plenty of energy and expertise, identifying areas of interest for the focus group. A number of exciting hot topic conversations will follow with the outputs feeding into a white paper to help advise data managers on a global scale.
The next meeting for the eDigital Group is on 2nd July 11:00-12:00 UTC and will encompass a wide area of discussion on regulation, covering topics such as GDPR, data ownership and potential for data reusability.
We welcome the input of fellow industry experts to provide additional viewpoints in to our discussions. If this is of interest to you and you would like to join click here for further details. Looking forward to seeing you there!
Online Training – Preparing for Regulatory Inspections
This course provides an overview of the critical preparation tasks required to ensure your inspection achieves the best possible outcome for your organisation. You will understand what regulatory authorities are and what they do, and then learn how they conduct inspections and the key information they are looking for. The learning outcomes for the course are as follows:
- Recap on the basics of ICH GCP focusing on the R2 addendum
- Gain a knowledge of the cascade of regulations that exist
- Understand the responsibilities of the regulatory authorities
- Recognise the different types of inspection and what the inspectors inspect against
- Understand the general inspection process
- Understand what an inspection dossier and inspection plan is
- Understand how to assure compliance to regulations
- Recognise what you must do to prepare for an inspection
- Know how to prepare your work area before the Inspector arrives
- Understand how to interact with the Inspector
- Recognise some of the typical Data Management findings from inspections