Adaptive Platform Trial for Community-Acquired Pneumonia Data Collection
"Explore a Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia Data Collection including eCRF eligibility and follow-up mortality rates after CAP. Learn about SAE reporting, protocol deviations, and more."
Uploaded on | 0 Views
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
You are allowed to download the files provided on this website for personal or commercial use, subject to the condition that they are used lawfully. All files are the property of their respective owners.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.
E N D
Presentation Transcript
Randomized, Embedded, Multifactorial Adaptive Platform trial for Community- Acquired Pneumonia Data Collection
eCRF Eligibility https://www.researchonline.org/ (Google Chrome/Firefox) General account Personal account
SAE (i) Event that is fatal, life-threatening, results in (or may result) in disability that is long-lasting and significant, or results in a birth defect or congenital anomaly Complications of the underlying critical illness and its treatment do not require specific SAE reporting End-points of study designed to pick-up majority of potential events Only report SAE if related, or suspected to be related to, study medication or participation If occurs between randomization and hospital discharge censored at day 90 need to be recorded
SAE (ii) Report immediately (within 24 hours) to coordinating centre UMC Utrecht; prepare_icu@umcutrecht.nl) Personal data must be pseudonymised before transmission using the trial number Document in patient medical notes and eCRF
Protocol deviations Could cover eligibility or treatment deviations May affect: Rights & safety of subject and/or Completeness, integrity, accuracy of data E.g. inclusion of subject < 18 yrs Complete Protocol Violation form (in ISF) Report to Sponsor
Randomized, Embedded, Multifactorial Adaptive Platform trial for Community- Acquired Pneumonia Day 180 Follow-ups
D180 Follow-up Mortality rates after CAP Functional outcomes and quality of life Vital Status EQ-5D-5L WHODAS 2.0 Baseline questions Evaluation of consent practices Ethics questions
D180 Follow-up Only for those patients who have consented to be contacted To be carried out by ICNARC CTU Sites to add contact information on: https://ctu.icnarc.org/macro/
