ClinicalTrials.gov Hot Off the PRS! Update -- Aug. 6, 2019
National Library of Medicine sent this bulletin at 08/06/2019 12:58 PM EDT
Welcome to Hot Off the PRS!
We are excited to share the first Hot Off the PRS! bulletin. We are planning to use the bulletin to provide timely announcements about the Protocol Registration and Results System (PRS), including updates on new features planned for the PRS, 42 CFR Part 11 implementation, and resources for PRS users. We will still continue to post announcements of new features and resources when they are available in the What’s New on ClinicalTrials.gov and in the PRS. We hope you find Hot Off the PRS! to be a valuable resource for staying informed.
Note: This bulletin replaced the NIH FDAAA Update listserv on Aug. 1, 2019.
Parallel Study Design Example Has Been Updated
The Example Studies for Results Data Entry are example study records and study papers that are useful for understanding key concepts for results data entry in the PRS. The Parallel Study Design example has been updated for consistency with the data elements and content in the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). The example also now reflects the current display of study results information on ClinicalTrials.gov. More updates for these example studies are currently in progress. We'll keep you updated when they're available.
November 2019 Results Database Train-the-Trainer Workshop Registration Open
Do you want more hands-on practice with results data entry? If you're responsible for providing ClinicalTrials.gov training and support to others at an academic institution, consider applying to attend the Results Database Train-the-Trainer Workshop. The workshop will be held Nov. 4-5, 2019, on the NIH campus in Bethesda, MD. More information for the Train-the-Trainer Workshop is on the Training Materials page, including registration information.
Not able to attend in November? We're planning another Results Database Train-the-Trainer Workshop for May 18-19, 2020, at NIH. More details on this workshop will be available in 2020.