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 launch of Online Training
Online Training from the Association for Clinical Data Management are interactive voice and media based courses. Each course is broken down into sections and at the end of each section is a self assessment to allow you to check your understanding of the content. Once you have completed all the sections and the self assessments you can take the final examination and download your certificate of completion.
The first course available from the ACDM is Preparing for Regulatory Inspections. This is a really useful course for individuals and organisations across the world who may be subject to a regulatory inspection.
More courses are in development and will be available later this year.
The Conference was a huge success and we thank everyone who attended.
Minutes from the AGM have been finalised and can be downloaded here.
We are pleased to announce that Jon Wood was nominated for Honorary Membership as a thank you for his years of support to ACDM.
Watch out for news and updates on ACDM20 which is going to be held at the fantastic Clontarf Castle in Dublin.
CTU Data Management Expert Group
The first call for this Group was held last month. The call was an introductory session and the attendees discussed the topics that should be covered in the following meetings:
- Experiences of implementing new systems and CSV (experiences of RedCap Cloud implementation and validation)
- DSP toolkit
- Resourcing / planning / funding/ link to central monitoring – how is this done at CTUs?
- Platform Trials – How is this managed in EDC when new cohorts are added? Also consider on study amendments for EDC trials and how this is managed
The discussion starter for the next 3 topics should be decided at the next meeting.
Meetings will be every 6 weeks, 1:30-2:30 on Fridays.
This is the second of the Data Management Expert Groups to be set up. The eDigital group now has a new person to lead it and details of the first meeting will be sent to everyone who expressed an interest in joining.
If you would like to find out more about other Expert Groups or join one of the groups click here for further details
Here we share with you two articles we think you will enjoy:
White paper: Correction of ePRO data (by Elise Langenkamp)
ePRO solutions allow patients to report clinical trial information directly from mobile devices into electronic CRFs. Obviously, ePRO has a lot of advantages over paper and pen. Regulatory authorities however, have given critical findings related to handling of ePRO data in the past. This white paper describes the considerations regarding data changes in ePRO clearly and completely, providing options for sponsors.
Read the full paper here
A day in the life of a Statistician (by Phastar)
As statisticians, we love a bit of variation! A day in the life of a statistician at PHASTAR is no exception – depending on the stage of assigned projects and the nature of the studies we’re involved with, we could be providing input to the design of a study, calculating sample sizes, writing statistical analysis plans (SAPs), writing ADaM specifications, programming datasets, TLFs or efficacy analyses, or, providing expert statistical advice to our clients.
Read the full article here
This year’s annual conference of the Association for Clinical Data Management (ACDM) took place in Amsterdam. During a two-day event, the emphasis was on the growing challenges of multistream data capture in clinical trials, with additional focus on risk based monitoring (RBM) and regulatory inspection findings.
Read the article here
GSK and Pfizer merge healthcare businesses to make new £10bn consumer drugs giant (published in the Independent)
The move will allow Glaxo to split in two – one part selling over-the-counter medicines, the other researching new pharmaceuticals and vaccines.
Read the article here
If you have written an article or a blog that wish to share with ACDM members submit it here.
The results for the ACDM Annual Awards are:
Individual Excellence in the Management of Clinical Data Award
- Valerie Cotonnec, Servier (winner)
Team Excellence in the Management of Clinical Data Award
- Manchester CTU Data Management Team (winner)
Innovation in the Management of Clinical Data Award
- Phastar clinical data ops team (winner)
Huge congratulations to the winners and all those shortlisted as finalists.
ACDM19 – we are still buzzing from this event
The photos are available to view online. They include photos from the conference sessions, awards as well as the dinner event on the boats.
ACDM Corporate Members can post data management related job adverts on the ACDM Website at no charge. View the latest job adverts here:
If you would like to post job adverts on the ACDM website you can login in here: https://acdmglobal.org/membership-area/