Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT04844034
Description:
Data will be:
* Fully anonymised
* Stored for 8 years as per University of Roehampton's Research Ethics Committee guidelines and Code of Practice.
* Appended to the final published report as supplemental material.
* Available from the corresponding author upon request.
* Handled, processed, stored and destroyed as per Data Protection Act (2018).
* Collected in Microsoft Excel worksheets in one file per type of experiment including original and normalised values; images/graphs will be stored as .tiff or .jpg files.
* Held encrypted on password-protected, university-owned drives.
* Accessible only by the investigators.
* Submitted for publication within one year.
* Deposited in a public preprint server (e.g. bioRxiv). Additional files with legends explaining how the data has been saved and described will be prepared to allow replicability.
All anonymised data volumes are expected to be small. Long-term backup/archiving will utilise secure in-house facilities and cloud-based storage.
Study:
NCT04844034
Study Brief:
Effects of a High EPA Multinutrient Supplement on Negative Affect in Young Adults.