Clinical research professionals have an obligation to uphold the highest ethical standards and strive for compliance with Good Clinical Practice (GCP). Contemporariness is not new as it comprises the first "C" is the ALCOA-C guidance, but recent regulatory guidance from MHRA and EMA has created new challenges and uncertainty within the industry with regard to its implementation in a TMF.
Contemporariness is not just isolated to the TMF, it is particularly a problem for multi-country studies spanning numerous regulatory agencies. The key challenges arise from not having clearly defined contemporariness in operational SOPs intended to ensure TMF completeness – this has resulted in MHRA audit findings.
Sponsors and CROs in an attempt to address the issue of contemporariness have relied in resource heavy and costly time stamping of all incoming site correspondence to start the measure. But, does this address regulatory concerns?
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Live: Thursday, December 12, 2019
1pm EDT | 12pm CDT | 10am PDT
On Demand: available after airing until December 12, 2020
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CHARITY METZ SCHULLER, Sr. Director Regulatory Affairs, PPD
Charity Schuller, PharmD MS, RAC, is a senior director of regulatory affairs at Pharmaceutical Product Development (PPD). In this role, she provides consultation to clients on global development strategies. She also interprets regulatory authority regulations and guidelines governing drugs and biologics. Dr. Schuller's experience includes regulatory project management and consultation, preparation and review of regulatory agency documents, support of REMS products and risk management programs, pediatric product development, late-stage research and post-approval maintenance. Her therapeutic expertise includes the areas of anti-infective, dermatology, gastrointestinal, endocrinology, oncology, ophthalmology, pain, pulmonology and rheumatology. Dr. Schuller also provides oversight of PPD's global regulatory intelligence, policy & advocacy and US regulatory teams. She has previously managed PPD's global regulatory compliance, electronic publishing and submissions and North America regulatory development teams. Dr. Schuller earned a Doctor of Pharmacy from West Virginia University, a Master of Science in clinical research from Campbell University and a Bachelor of Arts in chemistry from West Virginia Wesleyan College. In addition, she received her U.S. Regulatory Affairs Certification (RAC) in 2002.
MOLLY BROCK, Sr. Director Clinical Operations, PRA Health Sciences
Molly joined PRA as Sr. Director of Clinical Operations in 2018. Prior to joining PRA, Molly has over 14 years of clinical trial experience leading clinical research operations at academic medical centers. Molly is currently responsible for the eTMF system and enhanced site management at PRA.
KAREN ROY, Chief Strategy Officer, Phlexglobal
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our clients' TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as CSO, she leads all Phlexglobal partnering across the clinical space, has key strategic input into the development of our eTMF, PhlexEview, and serves as a Board member. Karen was also responsible for the development of the TMF Reference Model, an industry driven initiative to standardize the content, naming and structure of Trial Master Files. She still chairs the management of the Model – a Model used by the vast majority of Pharmaceutical companies and CROs.
ELVIN THALUND, Director, Industry Strategy, Oracle Health Sciences
Elvin is a recognized industry expert in clinical trials, having over twenty years of experience working as a Clinical Business Analyst Consultant at major pharmaceutical companies including, Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in Oracle Health Sciences effort to optimize study startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a Master of Science in Industrial Engineering from Aalborg Universitet.