This topic will focus on Risk Based Management from a variety of angles including the quality of the data produced.
Submissions should focus on matters related to risk-based approaches and how they impact CDM:
– RBM’s impact on CDM and visa versa
– Risk-based CDM approach
– QMP management
– QMP with source diversification
This topic should cover the methods of handling the collaboration between customer and clinical data management (i.e. CDM and clinical trial teams, CDM and sites, CMD and CRAs, CDM and subjects, etc.).
This topic should cover how CDM organization behaves with respect to the CDM community, what are the potential improvements we should work on in the future, what are the lessons learned from past experiences, etc.
This topic should cover real approaches on new technological and innovation approaches not covered in previous topic and/ or coming not necessarily from CDM (e.g. public health management, finance, physics, etc).
This topic should focus on real cases showing how academia/ Academic Research Organizations (ARO), CRO and pharma are handling data integrity for eSource, adaptive trial design, how they can assure quality by design, what are their perspectives about actual and potential consequences on CDM, how role & responsibilities are changing and will change in the transformation from CDM to Clinical Data Scientist, what will be the relationship with ‘other’ groups (ClinOps, medics, etc.).
This topic should cover real procedures on Data Management best practices and metrics for different data sources (wearables, apps, sensors, Big Data), application of ML/AI/Bots/Big Data Challenge in data analysis, Computer System Validation processes for home-grown applications/functionalities, new study designs, use of Real-world data in clinical development.
14 October 2019 Face to Face Meeting
Facilitator: Shobhit Shrotriya
Vice President, Clinical & Regulatory Services,
Accenture Applied Life Sciences Solutions
Reimagining Clinical Research – Enhancing the ‘Patient Centricity’ through Decentralized Clinical Trials
The world post Covid-19 will be different and continue to evolve in a dynamic fashion. Changes to the way clinical research is conducted today is certainly imminent. As one can imagine, the innovations in clinical research would happen now more than ever. During this panel discussion, we will discuss how decentralized clinical trials (DCTs) offer a more patient-centric approach with fewer visits to the clinic, thereby reducing the burden on investigator, patient and health caregiver. During this changing time, the critical imperatives of DCTs would be to focus on patient safety, ensure data quality and maintain research continuity seamlessly.
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Committee Chair: Meredith Zozus
Board Liaison: Linda King, Sanjay Bhardwaj, Deepak Kallubundi, Maria Craze, Meredith Zozus
The Content Alignment Committee is composed of two members from each of the GCDMP©, Certification, and Education Committees and members of the Board. The committee is responsible for increasing alignment between these three key SCDM offerings.
If you’re interested in joining this committee, please contact [email protected]