DIA’s Post

Register TODAY if you haven’t yet for the upcoming webinar tomorrow at noon PST to learn about key aspects to conduct #phase1 trials! #clinicaltrials #pharmacology

Start your research on day one with pre-assembled and expertly curated HealthVerity Mastersets! Through a rigorous process, we have resolved patient identity across all applicable data sources to reveal the most relevant clinical attributes for specific conditions and areas of study, from maternal outcomes to cause of death. All while governing data usage rights and applying advanced privacy-protecting techniques to preserve critical data elements. The result is a concise, easy-to-use masterset that provides speed to insight. Learn more and request a data sample https://hubs.ly/Q02ptdM30

🖇️ Come let’s talk about the clinical trials!! Embarking on the journey of clinical trials, the 'Data Lock Point' is a pivotal milestone, akin to a compass guiding us through the seas of research. 🔒 It's the moment when we secure our data fortress, ensuring the integrity and accuracy of our findings. With each lock, we safeguard the fruits of our collective dedication and propel towards a future of transformative healthcare. Here's to the Data Lock Point – where precision meets progress! 🌐📊 #ClinicalTrials #DataIntegrity #healthcareinnovation

To improve the informed consent process, the FDA and the Office for Human Research Protections (OHRP) announced the availability of a draft guidance entitled “Key Information and Facilitating Understanding in Informed Consent.” The guidance addresses the provisions of the revised Common Rule that require informed consent to begin with key information about the research and to present information in a way that facilitates understanding and identical provisions in FDA’s proposed rule.  #FDA #informedconsent #patientsafety #accesstocare #innovativeregulatorysciencegroup

Exciting news, because nothing gets my heart racing like a well-executed informed consent! The FDA has just released a new guidance document "Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards"   (If this proposed rule finalized, it would harmonize the FDA’s regulations on human subject protections with the revised HHS Common Rule.) Let's dive into 3 examples of ways you can present the key information section in an ICF: Structured Summary: Present key information in a structured format, providing bullet points or headings for easy navigation. This approach ensures essential details are prominently displayed, aiding participants in understanding the trial's purpose, procedures, risks, and benefits.    Visual Aids: Utilize visual aids such as infographics or flowcharts to complement written information. Visual representations can enhance comprehension, particularly for complex concepts or procedures, empowering participants to make informed decisions about their participation in the trial.    Plain Language: Communicate key information using clear and concise language, avoiding technical jargon or complex terminology. This approach promotes accessibility and comprehension, ensuring participants from diverse backgrounds can fully understand the information presented and actively engage in the informed consent process. Let's leverage this new guidance to enhance the quality and effectiveness of our research endeavors! https://lnkd.in/eaJJmyM8 #ClinicalResearch #FDA #InformedConsent #GuidanceDocument #EfficiencyTips

Check out the new ConsentTools toolkit developed by NIH-funded researchers to improve informed consent practices in #ClinicalResearch! Learn more and spread the word: https://ow.ly/ILAb50QSztL #CTSAProgram

The Real World Evidence Working Group is back with another insightful blog post! In our latest publication, we dive into the FDA's guidance on using registry data to support regulatory decision-making. This blog, crafted by the Quality and Reusability of Real World Data project, examines key topics from the guidance and highlights the challenges we face in current practices. Take a look at the blog post titled "RWD: The FDA’s Guidance on Assessing Registry Data to Support Regulatory Decision-Making" Read now: https://lnkd.in/eGjdUUqT Project Information: https://lnkd.in/erm6fmbG #PHUSE | Chris Price, Berber Snoeijer, Ashwin Rai, Parag Shiralkar

Do you use clinical trial data for secondary research? Join us on April 10 for an informational webinar on CRDSA’s Standard for Secondary Analysis, which was recently released for public comment. Learn more about how the standard will enable the conduct of good science and promote responsible secondary research use. Register today to help us shape this standard: https://lnkd.in/eM_hfz-r #patientdata #datastandards #clinicaldata #datasharing #clinicalresearch

View this short webinar to learn how CROs can tap into best practices for mitigating risk & addressing specific clinical supply challenges commonly associated with adaptive, decentralized, platform & other complex trial designs. https://ow.ly/nWjP50Q5Eyq

If your study team is overwhelmed by the latest innovations in clinical trials, our on-demand webinar will help you to understand the role of new technologies in optimizing study strategies, and how a robust data ecosystem can help. Watch now. https://bit.ly/4ajVPpO #clinicaltrials