Latest News from ACDM
Established in 1987, The Association for Clinical Data Management (ACDM) is a Membership Organisation for individuals and organisations involved in the management of clinical data. Please find below the latest news from the ACDM.
October 16, 2024 | News
Risk Based Quality Management DMEG Update – Recent Discussions
This year our focus has switched away from generalised RBQM to applying risk-based approaches to delivering Data Management. This is a huge topic and one that has stimulated much conversation over the course of our recent meetings. The DMEG has invested much discussion into the fundamentals of Risk-Based Data Management as well as discussions on how to pivot operational practices accordingly. We have been lucky to hear practical insights from some the DMEG members in these areas from projects that have or are running in their organisations.
Given the wealth of information and discussion that has taken place in the DMEG this year, our aim is now to distill our discussion and learnings into a paper that we can share with the wider ACDM membership. We look forward to being able to share more insights on this topic in due course.
– Rich Davies, Risk Based Quality Management (RBQM) DMEG Chair
Find out more about the RBQM DMEG here.
October 16, 2024 | News
Audit Trail Review DMEG Update – New Guide
The Audit Trail Review (ATR) DMEG has been hard at work putting the finishing touches on a paper around ATR, titled Getting started with Audit Trail Review in Clinical Trial data: An Essential Guide.
This guide draws on our combined understanding and knowledge of this complex process. The goal of the paper is to demystify the implementation of an ATR process for clinical trial data, outlining the essential aspects, with suggestions and recommendations for how organisations can get started with this process. We share examples of findings and operational insights into the process, discuss CRO and Vendor perspectives, and conclude with thoughts on future directions in the ATR space.
We are pleased to share that the paper can now be read on our ATR DMEG page. Click here to find out more about our work and view the paper.
– Jennifer Nielsen, ATR DMEG Chair
September 24, 2024 | News
Regulatory Considerations DMEG Update – September 2024
The Regulatory Considerations DMEG are waiting for the release of ICH GCP E6 (R3) Annex 1 effective (expected by end of the year) and Annex 2 draft for review by end of September. Once released, we expect to review Annex 2 on behalf of ACDM and send comments to the authors.
In June, I attended as a representative of the ACDM at a GCP Inspectors Working Group, where there were representatives from the Danish regulatory authorities, the eClinical Forum Essential Metadata team, and the industry. The scope of the meeting was to gather feedback on the ongoing work on essential metadata conducted by the eClinical Forum. It was a two-day meeting, with the first day focused on essential metadata and the second day on new potential guidance regarding AI.
The authorities have received many questions asking about what is or is not essential metadata, the stance taken in ICH E6 (R3) is that it is the sponsor’s responsibility to define the essential metadata for their trial, and to ensure that all essential metadata remains available for inspection (in the TMF, in the original system, or in some other fashion) for the full retention period. The inspectors will then comment on the available essential metadata when performing inspections. It was decided that there should be a formal presentation of the list produced by the eClinical Forum to the full EMA GCP IWG when it is released, and that this is preliminarily planned for Q1 of 2025.
With regards to the AI session, the industry stakeholders at the meeting agreed that the draft AI guidance document written by the DKMA was a good guidance, and they would like to see it released as an EMA guidance.
– Silvia Perez Torres, Regulatory Considerations DMEG Chair
Find out more about the Regulatory Considerations DMEG here.
September 23, 2024 | News
Guidance for Industry: Conducting Clinical Trials With Decentralized Elements
The Conducting Clinical Trials With Decentralized Elements final guidance has now been released, and provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.
September 23, 2024 | Article
Digital Data Flow (DDF) integration through the lens of electronic Patient-Reported Outcomes (ePRO)
This article has been submitted by Leeni Joshua of ICON plc
Introduction:
Digital Data Flow (DDF) provides a mechanism to modernise clinical trials, facilitating a digital workflow that enables the automated generation of study elements and configuration of study systems to support the execution of clinical trials.
DDF initiative supports the creation of a digitised protocol that can be used by the downstream systems involved in the execution of the clinical trial. As a result, this enhances the flow of clinical information by improving its quality and relevance, while ensuring traceability across systems. Consequently, it leads to enhanced and optimised processes throughout the entire life cycle of the clinical trial.
The Role of ePRO in Clinical Research:
Patient-Reported Outcome (PRO) measures play a crucial role in clinical research, providing information that formsthe basis for decisions related to study design. The increasing adoption of electronic Patient-Reported Outcomes (ePRO) has transformed the landscape of data collection in clinical research, enabling traceability, automated dataflow and interoperability between systems.
This article explores the integration of DDF with both upstream and downstream processes in the context of ePRO, highlighting the challenges faced and the advantages gained in leveraging DDF as a foundation for data exchange, leading to greater compatibility among systems, flexibility to sponsors, and improved clinical trial efficiencies.
Interconnected Processes with DDF:
The upstream and downstream processes in DDF are interconnected using a common, industry-standard StudyDefinition Repository (SDR). DDF uses these standards to digitise the information related to major protocol components such as study information, study objectives, endpoints, inclusion/exclusion criteria, schedule of activities, and more.
By establishing a lineage between the Schedule of Activities, visit information, and data definition in a Metadata Repository, it becomes possible to automate the study build process in EDC and generate Data Transfer Specifications for ePRO.
Integration of DDF with these processes encounters challenges such as standardising diverse data inputs. For example, instruments like the Patient Global Impressions scale or the Pain intensity scale, which are in the public domain, do not have a single standardized version. This is due to the inclusion of the specific disease/condition, signs related to the disease/condition, function, and/or functional impact of interest within the wording of the global item; Additionally, the response options on these instruments vary and have not yet been standardised.
Questions also emerge in ensuring compliance with existing regulatory standards such as the CDISC controlled terminology. The test concepts and codelists assigned to questionnaire items in the SDTM terminology and SDTMIG supplements are typically derived from traditional paper versions. However, Issues may arise when items from the ePRO system are submitted differently due to programmatically derived or concatenated data. These issues can result in downstream errors, specifically with Pinnacle 21 (P21) validation rules.
Nonetheless, since DDF is agile and vendor agnostic, any product or platform capable of consuming data in a CDISC standard format can be easily integrated into the digital data flow and accommodate any change in standards, minimising the impact on ongoing trials and reduce the cost in change management.
Transformative Impact of DDF Integration:
Most PROs are standardized tests that is of Classical Test Theory (CTT), which are composed of a fixed number of items – that is, a question and its associated response scale and results in summed scores and requires respondents to complete the entire test for comparability. While they may be simple to administer, it may lead to increased burden due to the quantity of questions required to be answered, especially when the subjects are asked to complete multiple PROs together. Computerized adaptive tests (CATs) instead, use a variable number of items selected from a larger set of items, also known as an item bank. The item bank typically provides information across the full range of severities of a particular concept of interest, for example, physical function. Each subsequent item is selected based upon the responses provided to all the previous items. In this way, the response to each subsequent item becomes more focused and precise, leading to a higher level of confidence in the final estimate or score of the concept being evaluated. When sufficient confidence in the reliability of the estimate is achieved, the test can stop, and no further questions are required.
DDF opens doors to create end-to-end lineage and automated information flow between the clinical protocol and the downstream ePRO systems, thereby using advanced analytics such as IRT in CAT to enhance the optimisation of study design and refining analysis populations, scheduling of activities, patient engagement and operational efficiencies.
Addressing Technical and User Challenges:
The implementation of electronic clinical systems can be challenging in general, and ePRO systems are particularly susceptible to difficulties. In addition to facing typical technical issues, ePRO is also used by potentially thousands of study participants, many of whom may have limited technical understanding. Therefore, to ensure that all trial participants are included, the implementation of ePRO systems may need to be done in parallel with existing paper PRO collection systems.
Conclusion:
In summary, the integration of DDF with upstream and downstream processes involving ePRO presents challenges,particularly those related to regulatory compliance, technology barriers and costs of change management. However, it is important to consider these concerns within the context of early adopters’ success and the increasing interest and support from the FDA.
The effective integration of DDF not only improves data quality and integrity but also accelerates processes, empowers decision- makers, and contributes to advancements in patient-centric clinical research.
April 23, 2024 | New Member
Welcome FGK Clinical Research as a new corporate member
The ACDM: Association for Clinical Data Management is delighted to welcome FGK Clinical Research as a new corporate member.
FGK provides full service for clinical studies to biotechnology, medical device and pharmaceutical companies. They have the right size to handle international multi-center studies with hundreds of patients or single country studies with a few patients, but is still small enough to guarantee a personal service to the sponsor.
FGK Clinical Research joined the ACDM to exchange ideas with the data management community and to learn from each other.
Members gain many benefits from membership, including:
- Access to training courses at a discounted rate
- Assign full ACDM membership to all individuals within your organisation
- Place an organisation profile, description and logo on the ACDM website
- Advertise jobs for your positions within your organisation
- Reduced price attendance at conferences and symposia
- Free attendance at Hot Topics
Find out more about becoming a corporate member here.
More News
Welcome LINK Medical as a new corporate member April 5, 2024
Welcome Zilla Clinicals as a new corporate member March 26, 2024
Challenge ChatGPT: CDMs vs AI March 22, 2024
Welcome Boehringer Ingelheim as a new corporate member February 6, 2024
Welcome Datacapt as a new corporate member January 12, 2024
Welcome Climedo as a new corporate member December 15, 2023
EMA Management Board: Highlights of October 2023 meeting November 27, 2023
Clinical Trials for Medicines – New Notification Scheme November 27, 2023
Welcome Mednet as a new corporate member November 22, 2023
Welcome Allucent as a new corporate member November 14, 2023
Welcome KCR as a new corporate member October 20, 2023
Welcome Debiopharm as a new corporate member October 3, 2023
European Medicine’s Agency – Reflection paper on the use of artificial intelligence in the lifecycle of medicines September 25, 2023
ACT EU PA04 – Multi-stakeholder Workshop on ICH E6 R3 September 25, 2023
HMA/EMA joint Big Data Steering Group: Big Data Workplan 2023-2025 September 25, 2023
Welcome Instem as a new corporate member August 16, 2023
ICH GCP E6 Revision 3 is here. Regulatory Considerations Expert Group to review. June 19, 2023
Regulatory Considerations Expert Group reviews draft FDA Guidance June 19, 2023
Welcome Algorics as a new corporate member May 18, 2023
Guideline on computerised systems and electronic data in clinical trials April 25, 2023
FDA Guidance for Industry April 25, 2023
New MHRA Guidance April 25, 2023
Consultation response on legislative proposals for clinical trials April 25, 2023
Welcome IROS – Insights Research Organization & Solutions as a new corporate member February 9, 2023
Recommendation paper on decentralised elements in clinical trials December 19, 2022
Welcome George Clinical as a new corporate member December 16, 2022
Welcome Clinion as a new corporate member December 7, 2022
Welcome ClinoSol Research as a new corporate member October 18, 2022
CTU DMEG Update September 29, 2022
ICH E8 (R1) General Considerations for Clinical Studies Impact on Data Management April 5, 2022
Have your say – MHRA’s public consultation on proposals for legislative changes for clinical trials January 26, 2022
Signant Health are ACDM22 Photography sponsors November 19, 2021
Anju Software is exhibiting at ACDM22 October 29, 2021
SGS Health Science to sponsor ACDM Awards for the second year running October 1, 2021
ACDM Interactive September 7, 2021
nuvoteQ to be a Premier Sponsor of ACDM22 August 23, 2021
IQVIA to be a Premier Sponsor of ACDM22 August 19, 2021
Anju Software to be a Premier Sponsor of ACDM22 August 15, 2021
CORE to be Premier and Interactive Sponsor for ACDM22 August 12, 2021
eClinical Solutions to be Premier and Communications & Social Media Sponsor for ACDM22 August 5, 2021
ACDM Annual General Meeting July 29, 2021
Phastar announced as Premier & Conference Dinner Sponsor of ACDM22 July 1, 2021
New online training course – Risk Based Monitoring May 4, 2020
Building data management success in Sponsor/CRO relationships online webinar 30th April April 22, 2020
ACDM21 – Location announced April 8, 2020
ACDM Hot Topic Discussion – Implications of COVID-19 on clinical data management activities globally March 31, 2020
ACDM eDigital DMEG publishes its GDPR Q&A report March 30, 2020
ICON to be Premier & Award Sponsors for ACDM20 December 2, 2019
New Online Learning Course – Understanding Laboratory Data November 19, 2019
Nominations now open for ACDM Awards 2020 October 14, 2019
Phastar announced as Networking Sponsor for ACDM20 July 9, 2019
ACDM20 Dates & Venue July 1, 2019
Launch of Online Training from ACDM March 24, 2019
ACDM 2019 Awards Finalists February 22, 2019
Castor EDC to Sponsor ACDM19 January 15, 2019
Danone Nutricia Research to Sponsor ACDM19 November 26, 2018
ACDM19 Conference Programme November 21, 2018
Record Number of Abstracts Submitted for ACDM19 October 1, 2018
Phastar Sponsor ACDM19 September 3, 2018
Launch of Annual ACDM Awards September 1, 2018