Community Home

Log in or Join to View Discussions

Latest Discussion Posts

  • Hello All,   Welcome to all the new members of the CTD Community! Several of you have reached out to me with questions about our monthly conference calls.  Please find some useful information below. Meeting Schedule The CTD Community Call happens ...

  • Dear DIA Community, I would appreciate any feedback on the strategy and methodology for uploading final results of a completed clinical trial via the EudraCT account of the sponsor. BACKGROUND: EudraCT allows for entry of data fields for results-related ...

  • Please join us for the CTD Community call on our monthly conference call on Tuesday, August 11 at 10am EST.     This month, we will likely have a lot of questions and discussion about the recent guidance on results for pACT (pre Final Rule Studies).  ...

  • Dear all,  On July 29 th the Health Research Authority (HRA) unveiled its much-awaited  strategy  on how it plans to improve clinical trial transparency in the UK with provisions that will introduce "fair consequences for those who don't take transparency ...

  • Dear All, The following update has been published on UK Health Research Authority portal: Make It Public – new strategy marks step-change in making health research findings available to the public : It mentions that HRA now begins work to implement ...

  • Dear Sanjay, Thank you for Sharing this update. ------------------------------ Raj Aggregate Safety Reporting - Pharmacovigilance ------------------------------

  • Dear All, Following the recent update on FAQs regarding Federal Court Decision, please see below the expected update on PRS to go live on July 30, 2020: pACT Results Submission Change As a result of a recent Federal court decision, some studies ...

  • On July 28, 2020, Clinicaltrials.gov has published updated information regarding Submission of Results Information for ACTs Subject to the Registration Requirements and Completed Before January 18, 2017, Following the Federal Court Decision in  Seife ...

  • Hello All, The EMA has asked me to share the following: Please note that t he EudraCT system [ http://eudract.eudra.org/ AND https://eudract.ema.europa.eu/ ] will be unavailable this evening Tuesday 28 July from 6.00pm until 8.00pm while we ...

  • Dear All, On July 15, 2020,  Factsheet on MDR requirements for Transparency and Public Information  was published. The purpose of this fact sheet is to list information which will be available to the public in accordance with transparency obligations ...

Upcoming Events