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Overview of Data Quality and Compliance Checks
Published in Sunil Gupta, Clinical Data Quality Checks for CDISC Compliance Using SAS, 2019
See figure A.1 for general process flow of SAS programs. See figure A.2 for data model of datasets and key variables. By focusing and being proactive to address potential data and compliance issues, SAS programmers will inherently become expert SAS programmers and more knowledgeable about the eCTD filing process and future industry standards. Join the growing SASSavvy.com community for the latest CDISC and SAS programming tips. Please contact the author at [email protected] for a copy of the SAS examples and any SAS programming or CDISC-related questions. All data in this publication is completely fabricated by the author. The output seen in tables and figures is essentially random but tends to be representative of a typical clinical trial. Any resemblance to live data is purely coincidental.
The role of electronic tracking in monitoring data output in clinical trials
Published in Frank Wells, Michael Farthing, Fraud and Misconduct in Biomedical Research, 2019
Erick Gaussens, Pierre-Henri Bertoy, Jean-Marc Husson
Finally, we shall highlight the fact that, from an IT perspective, preventing fraud and misconduct could be supported by moving from information silos to an organized system. This move underlies a number of other initiatives, such as the eCTD Life Cycle,12–14 a risk management plan for safety issues,5 and the ICH Q 10 guidance,15 which aims to ‘develop a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science’.
10th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals
Published in mAbs, 2020
S. Tourdot, A. Abdolzade-Bavil, J. Bessa, P. Broët, A. Fogdell-Hahn, M. Giorgi, V. Jawa, K. Kuranda, N. Legrand, S. Pattijn, J. A. Pedras-Vasconcelos, A. Rudy, P. Salmikangas, D. W. Scott, V. Snoeck, N. Smith, S. Spindeldreher, D. Kramer
Dr. Joao Pedras-Vasconcelos from US FDA’s Office of Biotechnology Products, USA provided some practical guidance on Immunogenicity Risk Assessment and data presentation for regulatory dossiers. Currently, the data relevant to the assessment of immunogenicity for therapeutic biologics are dispersed throughout different locations of the eCTD, including 2.7.4 Summary of Clinical Safety, 5.3.1.4 Reports on Biopharmaceutical Studies and 5.3.5 Reports of Efficacy and Safety Studies. The scattering of immunogenicity information in the regulatory file makes both the applicant’s preparation of the immunogenicity information and the subsequent FDA review process quite challenging. To facilitate both the clinical development of therapeutic biologics and the subsequent regulatory review process, FDA recommends a life-cycle management approach to immunogenicity through the creation of an Integrated Summary Immunogenicity report that applicants begin populating early in product development, and update at regular intervals as the individual product clinical program progresses through IND filing to BLA submission and even post-approval stages. This recommendation was formalized in the finalized FDA ADA assay validation guidance Immunogenicity Testing of Therapeutic Protein Products – Developing and Validating Assays for Anti-Drug Antibody Detection published January 2019 and harmonizes well with EMA immunogenicity guideline recommendations.