Insightful Study on Cardiovascular Health in 40-Year-Old Individuals
This proposed study focuses on investigating cardiovascular health in individuals aged 40, aiming to enhance understanding and improve outcomes. The study involves various aspects like scientific rationale, participant involvement, data collection considerations, and more.
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
Title of Proposed Study Lead Investigator(s) Names CARDIA Year 40 In-Person Examination Ancillary Study Request
Proposed Investigator(s) PI Co-Is COI/RWI
Brief Approach/Methods Review Include recruitment, study procedures, feasibility, implementation considerations
Participant Involvement/Burden (if applicable) Description of each item (questionnaire, procedure, image acquisition, phlebotomy, etc) Time of each item, total time anticipated See table in ancillary study application Measure Participant Involvement Participant Time
Field Center Burden (if applicable) See table in ancillary study application
Coordinating Center Involvement (required) See table in ancillary study application
Reading Center/Lab Involvement (if applicable) See table in ancillary study application
Data Collection, Transfer, and Sharing Considerations
Funding Plans and Proposed Timeline Funding source Submission date Proposed start date
Addressing Non-Negotiables Single IRB costs - ancillary study PIs will contact the Birmingham Field Center regarding single IRB costs. Structured data flow - Field Centers will send the data to the CC and the CC will provide the data to the ancillary study PIs via SharePoint. Imaging data will be sent to the Reading Centers. If the data flow plan is not possible, an alternative plan will be discussed. A detailed and clear scope of work: Effort for adequate staff (i.e., clinic coordinators and project managers). A minimum effort of 10% or appropriate effort should be allocated for staff leadership. Minimum effort for investigator time (5% for principal investigators) should be provided for the duration of the study. Ancillary study PIs are highly encouraged to provide monetary incentives as well as tangible results. The incentives will be reviewed for market value. Coordinating Center: Effort for PI, program manager, and data manager
