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Happy to share that I completed NIDA Clinical Trials Network's course on Good Clinical Practices (GCP). Feeling empowered with the new skill. #clinicalresearch #clinicaltrials #medicalwriters #clinicaltrial #clinicalskills #clinicaltraining

❓ Who needs to do clinical evaluation?   ❓ Why is it important?  ❓ What key documentation do you need? Our free webinar covers all of this – and more! You can even catch a preview below as we talk through State of the Art (SOTA). Catch up on the full webinar here: https://lnkd.in/eEDQQRRt  Nailing the basics of clinical evaluation can be tricky – especially when you’ve got a large team to train up fast. That’s why our group training is ideal. Your team will get a chance to learn and network in an interactive environment.    And on top of that, you’ll have access to an SME who can guide you through the current challenges you’re facing.    Sign your team up now – you'll even get a discount on three or more seats. Book now by visiting https://lnkd.in/gXncxJ6U, emailing info@meddevsolutions.co.uk or calling +353 91 394 804. #ClinicalEvaluation #StateOfTheArt #SOTA #MedicalDevices #QARA #MedtechTraining #Clinical  

At BCRI, we provide comprehensive Clinical Data Management (CDM) training. Our program covers various aspects including protocol review, data validation, CRF design, and SAE reconciliation. Through our training, participants gain expertise in managing clinical data effectively and ensuring compliance with industry standards. #ClinicalDataManagement #CDMTraining #ProtocolReview #DataValidation #CRFDesign #SAEReconciliation #ClinicalResearch #HealthcareTraining #BCRI #ClinicalTrials #DataQuality #ComplianceTraining #ResearchMethods

Missed our recent webinar series on How Digital Regulatory Tools Can Accelerate Your Clinical Performance Study? No need to worry! ARC Regulatory are excited to share that the recorded webinars are now publicly available on our website. Don't miss out on ARC Insights and learn from our SME's on how you can enhance your clinical performance studies with digital tools here: https://lnkd.in/evZ7yTjT #TeamARC #Webinars #ClinicalPerformance #IVD #CDx

It's time to end #clinicaltrial site budget holdbacks. I’ve been in #clinicaltrials long enough to remember some of the stories we used to hear about sites doing clinical trials and not properly completing the CRF and the monitor having to sit with a site coordinator and guide them to transcribe the data onto the 3-part NCR paper. (Deep breath after a long run-on sentence. Pause for dramatic effect…) Sponsors cited examples like this as rationale for creating holdbacks in clinical trial budgets. To ensure they got their data, they would keep a percentage of the funds owing to the site until the end of the study. Well, paper CRFs are a thing of the past and budget holdbacks should be abolished too. Thanks to EDC and IRT and many other acronyms, sponsors have the data within a few days after the visit. It’s even baked into the contracts. There is simply no good reason to hang onto the funds the site has rightfully earned. Being a “sponsor of choice” is a buzz phrase for the industry now. If that’s a goal for your company, but you are still holding back funds from sites, you’ll never achieve it. Holding back sites’ earned funds until the end of the study is a ridiculous notion and costs the sites significantly. Let’s put an end to this archaic practice. #clinicalresearch #clinicalstudies #clinicaloperations

ACDM Hot Topic on Clinical Trial Computerised Systems taking place next week…… Join us on October 26th for the next ACDM: Association for Clinical Data Management Hot Topic Discussion “How long should your Clinical Trial Computerised Systems be kept online?”, which will be led by Alan Yeomans of Viedoc. The use of electronic tools and platforms to drive data collection during clinical trials has brought associated challenges with regard to both the long-term retention of data and the ability to reinstate decommissioned computerised systems, whether or not such systems are in use across multiple trials or deployed for use in a single trial. This session will discuss the timing of system decommission, the viability of data formats and the inherent benefits of standards. Find out more and book your place here: https://lnkd.in/ewtkdHQ2 ACDM Hot Topics are one hour online virtual sessions which include a short presentation to set the scene followed by an open-to-all discussion. They are free for ACDM Members and a small charge is made for non-members. ACDM Board: Ian Pinto, Bertrand Le Bourgeois, Robert King, Sverre Bengtsson, Jo Marshall, Ramlal Waghray, Richard Munday, Ioulietta Mulligan, Nina Reyes #clinicalresearch #clinicaltrials #clinicaldatamanagement #clinicaloperations #edc #acdm

Once upon a Time… with Sponsor Oversight and Data Governance 🚀   I was responsible for a clinical trial that was being conducted in collaboration with a Contract Research Organization. In the beginning, the CRO was not informed of sponsor expectations related to clinical trial data quality. The clinical trial had been conducted for a while, based on assumptions and interpretations. Communication was not been concise and clear. 😕   Based on ICH E6 (revision 2), we then agreed on data quality indicators and related tolerance limits. Communication improved and sponsor expectations became clear.   In the end, both parties used less effort to provide and review clinical trial data sets, achieving milestones as agreed.   This simple case study reflects on the importance of Sponsor Oversight and Data Governance. 💡   The sponsor should ensure that the ·      Clinical trial design ·      Clinical trial conduct ·      Processes undertaken ·      Information and data generated   are of sufficient quality to ensure ·      reliable clinical trial results ·      clinical trial participant’s safety ·      appropriate decision making   #ClinicalTrials #GCPUpdate #ClinicalExcellence

Hope you like the first in a series on a detailed analysis of FDA findings from inspections that resulted in 483's. Are you sure that these errors are being identified in YOUR trials. Try our Study Health Check (SHC), an independent and objective assessment of trial quality in five areas: informed consent, primary endpoint, subject safety, investigational product, and major deviations to know for sure. SHC can be implemented at any time during your trials so that you don't end up at inspection time with findings such as these.

🔍 Exciting News! Join Us for Our Masterclass on Clinical Trial Quality & Inspection Updates! 🔍 📅 Mark your calendars for June 10th–12th, 2024! 📅 Are you ready to stay ahead in the world of clinical trials? Don't miss out on our upcoming masterclass where we'll dive deep into the latest updates on clinical trial quality and inspection. Whether you're a seasoned professional or new to the field, this event is designed to equip you with the knowledge and insights you need to excel. Key topics include: ✅ Updates on regulatory standards ✅ Best practices for ensuring trial quality ✅ Navigating inspection processes with ease Secure your spot today and elevate your expertise! Comment "INTERESTED" to know more details and secure a discounted slot! #ClinicalTrials #QualityAssurance #ProfessionalDevelopment #Masterclass #StayUpdated

FDA BIMO 483 findings: More than a decade with no change Insanity is doing the same thing over and over and expecting a different result.  As we look at the data on 483 findings from FDA clinical investigator (site) inspections from over a decade (shown above), we can see the same errors at the top of the leaderboard each year. In 2020 and 2021, the FDA broke down these large topic areas into their components. You can see that this breakdown enhances our understanding and show the value of a controlled vocabulary. Let’s start with Informed Consent.  The FDA listed the following themes for Informed Consent: ·       ICF Not Obtained ·       Revised consent not obtained/timely ·       ICF not obtained prior to screening/reconsent/IP admin ·       ICF not obtained at rescreening ·       ICF not obtained for Sub-Study ·       ICF copy not provided ·       ICF Changes not approved by IRB ·       ICF Not in Understandable Language ·       ICF Short Form Not Witnessed ·       ICF Circumstances—not sufficient opportunity/not enough time ·       ICF coercion Note that these findings are categorized in two places:  ICF (50.20) and Protocol compliance (312.60/812.100, 812.110(b).  Ideally, from an analysis standpoint they would be classified in one place. There was no way to know that ICF findings were in two places without the breakdown provided recently.  Another learning—classify items consistently and in one place for best insights. Many of the errors are not at the beginning of the trial but are more likely to happen when there are changes or amendments.  Everyone knows that you need to have an IRB approved consent obtained at the start of the study.   When there are amendments, are your site processes set up to identify when a new amendment and consent have been IRB approved so that subjects can be reconsented promptly?  Debra Fontana recently posted about the importance of a eTMF index to assure that all documents FOR EACH STUDY CHANGE are included in the eTMF. From a risk standpoint, what are your oversight methods that will identify whether the changes from an amendment are implemented correctly? Note, this requires study specific analytic methods, which are more effective than manual checks. They can be implemented faster and don't require a monitoring visit to identify the error. Stay tuned—my next posts will  cover the rest of the breakdown and some innovative approaches to prevent these errors from derailing your development. Feel free to contact me if you would like to implement ongoing quality oversight for your trials to prevent these types of errors.