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    Remote Consent Form

    Dear Colleagues, Does anyone have experience in remote Consent in clinical trials? I am collecting information for an article and all answers will be more than appreciated. If you have any publications about this some bibliography will be even more appreciated. ...

  • As COVID eventually stabilizes, many Sponsors, CROs, Academic Institutions, and Regulatory Agencies, can reflect on the great progress made in the use of telemedicine, remote monitoring/SDV, drug shipping to local clinics or homes for administration, ...

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  • Dear Colleagues in the DIA Clinical Research Community, Hope you are well and safe. The mission statement of our Community says: " Our international forum provides a vital exchange of information on best practices, current clinical trials, and educational ...

  • Leaders from the DIA Study Endpoints, Clinical Research, and Statistics & Data Science Communities are organizing a Working Group with a goal of tackling the important topic clinically meaningful change – moving the discussion beyond MCID/MID and homogenous ...

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  • Title: THE POWER OF AI IN BIOLOGICS DRUG DESIGN, PRE-CLINICAL AND CLINICAL DEVELOPMENT Date: 21 July 2020, 10:00am - 11:30am EST (14:00 - 15:30 GMT) Registration Link:   https://diaglobal.zoom.us/webinar/register/WN_VUvDHq7fRzO_057PMaZRr4 Brought ...

  • COVID-19 has had a significant impact on the conduct and planned analysis of ongoing trials not to mention the design of new studies. Time CRAs can spend at sites will be limited. Performing remote site visits via "Zoom" like tools is an option. Remote ...

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  • The U.S. Food and Drug Administration issued an updated guidance, "Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic," with an appendix adding questions and answers on this subject. We plan to update this appendix as new questions ...

  • In Nov 2019 an important ICH guidance came out that impacts the design, conduct, analysis and reporting of clinical trials. Please take the 2 Minute Survey at link: https://www.surveymonkey.com/r/ICHGuidance-CTs ------------------------------ Munish ...

  • The EMA management board endorsed  to  commence the system audit of the Clinical Trial Information System (CTIS) in December 2020. This will start the clock when the new EU Clinical Trial Regulation will finally be implemented,  vastly changing how clinical ...

  • I am a doctoral candidate at USC and I am conducting an academic research study of industry views on the implementation of decentralized clinical trials for my thesis. This study will evaluate how, why and at what rate decentralized clinical trials ...

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