DMP Template for Randomized Clinical Trials

DMP Template for Randomized Clinical Trials

Authors
Dr. Anna Catharina V. Armond, Dr. David Moher, Dr. Florian Naudet, Dr. Dean Fergusson, Dong Vo, and Dr. Kelly D. Cobey
Discipline
Cardiology
Funder
Tri-Agency
Field
Medical, Health, & Life Sciences
Organization
University of Ottawa Heart Institute; Metaresearch and Open Science
Location
Canada
Description

Developed by researchers for the University of Ottawa Heart Institute, this guidance and worked example outlines a data management plan for a randomized controlled trial conducted with 100 human participants. Demographic data will be collected from participants, and then other data is collected by an electroencephalogram, electroculogram, electromyogram, as well as video and sound.

Date Last Modified
2024
Keywords
randomized clinical trial
RCT
sensitive data
sleep
PHI
REM
Federated Research Data Repository
statistical analysis plan
SAP
ethics
protocol