Good Clinical Practice
22 videos · last 6 months shuffled daily, then older videos newest first
▶
58:32 Sponsor Oversight of CROs: Practical Strategies
Phortas presents a webinar for biotech sponsors on CRO oversight, covering regulatory expectations, vendor governance, KPIs, sponsor oversight plans, oversight visits and inspection readiness.
▶
8:24 The Clinical Data Lighthouse: Partnerships on the Road to Vision 2030
Ward Lemaire talks to Myriam Salem, National Supervisor of the Clinical Trial Compliance Program at Health Canada, about implementing ICH E6(R3) and the regulator's role in supporting innovation.
▶
1:18:58 The IRB and Ethical Use of Human Subjects in Research (Responsible Conduct of Research 2026, 6)
University at Buffalo research compliance director Richard Karalus presents the Nuremberg Code and Belmont Report and how they apply to designing human subjects research, with case examples.
▶
6:24 "Data Integrity" at Texas Site During Pfizer COVID Vaccine Clinical Trial
BMJ interviews a whistleblower who discusses "data integrity" and other issues with a vendor in Texas during a trial of a Pfizer COVID-19 vaccine.
▶
8:11 Why Signing In and Out of a Study Matters for the TMF
A TMF Daily Podcast episode on why signing in and out of a study matters for traceability, audit findings and keeping the Trial Master File inspection-ready.
▶
6:46 The Inspection XII - Update 2026
GCP-Service International on its recent GCP inspection, from the draft inspection report to final implementation.
▶
14:13 PD: Progressive Disease or Protocol Deviation - Explaining Both
Johannes Wolff of Oncology Consulting Wolff explains the two meanings of PD in oncology trials, progressive disease and protocol deviation, as part of his teaching series for oncology clinical drug developers.
▶
34:36 TGA's GCP Inspection Program for Clinical Trials
Australia's Therapeutic Goods Administration presents its Good Clinical Practice inspection program for clinical trials of medicines, biologicals and devices, in a session from 30 May 2024.
▶
1:04:39 Panel: The Evolution of QTLs in Light of ICH E6 (R3)
A CluePoints panel of industry leaders discusses the ICH E6(R3) shift from quality tolerance limits to acceptable ranges, the distinction between KRIs and QTLs, and how to define important deviations.
▶
1:21:32 What Makes a Clinical Trial GCP Compliant? (Good Clinical Practice 2024, 2)
Kimberly Brunton, RN, MSN, on who is responsible for what in GCP-compliant research — sponsor, clinical research office, IRB and study staff — with a focus on the investigator.
▶
10:10 CTCAE - Explaining Acronyms and How to Use Them in Clinical Development
Oncology consultant Johannes Wolff explains the Common Terminology Criteria for Adverse Events, which grade adverse-event severity in oncology drug development, as part of a teaching series for clinical drug developers.
▶
32:42 How to Register Your Trial on ClinicalTrials.gov
Urmo Jaanimägi, Quality Assurance Specialist at the University at Buffalo CTSI, explains how to register a study on ClinicalTrials.gov through the Protocol Registration and Results System, and what happens if it is not.
▶
55:04 D1S03 - Clinical Trials with Decentralized Elements
The FDA sets out its Good Clinical Practice expectations for trials with decentralized elements, covering risk assessment and what its inspections have found.
▶
13:29 Best Practices in Adverse Event Reporting
RQM+ safety management manager Melanie Miller covers adverse event definitions for devices versus drugs, global reporting requirements and timelines, and the minimum data set for reportable events.
▶
27:10 NIH GCP Training for Social and Behavioral Research
Melissa Riddle, PhD, of the NIH gives an overview of the Good Clinical Practice for Social and Behavioral Research eLearning course, updated in 2024 with training on regulatory changes and reporting requirements and a module on community engagement.
▶
1:21:22 Good Clinical Practice and Ethics with Holly Tabor, PhD
Holly Tabor, director of the Stanford Center for Biomedical Ethics, discusses current and emerging ethical issues in Good Clinical Practice, with case examples and approaches to address them.
▶
57:57 Making Good Clinical Trials Easier & More Equitable: Updated ICH GCP Guidelines
Professor Sir Martin Landray and Nick Medhurst of the Good Clinical Trials Collaborative on the updated ICH Good Clinical Practice guidelines.
▶
45:06 ICH E6 (R3) & E8 (R1) Guidance Update
CluePoints and ZS Associates trace monitoring guidance from ICH E6(R2) through E8(R1) and E6(R3), addressing misconceptions about risk-based monitoring, SDV, centralized monitoring and QTLs.
▶
38:19 Clinical Research in India and the U.S. Compared
Sanket Shah, a clinical research leader at Shine TCS, compares how trials are run in India and the United States on the TMF Daily podcast, covering operations, culture, regulation and quality systems.
▶
36:33 Translation Accuracy and AI in Global Clinical Trials
Duncan Shaw, President and Owner of DTS Language Services, discusses translation risk in global trials, regulatory-grade accuracy for sponsors, CROs and IRBs, and the limits of AI translation, on the TMF Daily Podcast.
▶
1:58:36 Good Clinical Practice Considerations for Clinical Trials Day Two 9.13.23
Researchers describe their experience running trials with pragmatic or decentralized features, at a two-day public meeting convened by the Reagan-Udall Foundation.
▶
6:11 WhitehallTraining on Informed Consent Under ICH E6 (R3)
WhitehallTraining summarises the new informed consent requirements under ICH E6(R3) and what they mean for investigators, sponsors and research teams.