Training Logs in clinical trials: what to do & what not to do скачать в хорошем качестве

Training Logs in clinical trials: what to do & what not to do

In this one more episode of the CRA Corner Podcast, here's what we wanted to check in on: the Traaaaining log! Oh yes, those training records are way too important to miss a full conversation on them. We discuss the “if it’s not recorded, it didn’t happen,” we explain what belongs in a training log, including external certifications (e.g., GCP, IATA for those shipping lab samples), CRA/sponsor-delivered trainings (SIV, protocol/IB updates, manuals), and vendor/system trainings (e.g., EDC, eTMF/eISF), noting the frequent burden of repetitive system training across sponsors. We also chat about the most common inspection/audit findings around incomplete training logs, practical challenges like missing signatures and paper processes, and recommend maintaining a personal tracker and careful wording in monitoring reports, escalating concerns when asked to omit issues. This episode is brought to you by CRAConnect and Menken Trials. Connect with us: Connect with Maria Milas:   / mariamilas   Connect with Anna-Liisa Parts:   / annaliisaparts   Join the international CRA Community: https://craconnect.so/ Know more about Menken Trials: https://menkentrials.com/ TIMESTAMP: 01:13 Training Log Basics 02:39 GCP Requirements and Findings 04:29 Types of Training Records 06:38 Vendor System Training Headaches 10:16 CRA Delivered Site Training 11:42 Retraining and Report Wording 15:46 Reporting Ethics and Escalation 23:02 Signature Collection Challenges 26:10 Trackers and Going Digital 29:18 Wrap Up and Call to Action