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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT04476667
Description:
Ethics and Data Privacy: Only care providers involved in care of participant will have access to charts. Patients will only be identifiable by ID number on OPTT platform and real identity and consent forms will be stored locally in locked file cabinet and destroyed 5 years after study completion date. Only anonymized data will be provided to analysis team members.
OPTT is HIPAA, PIPEDA and SOC-2 compliant and all servers and databases are hosted in AWS Canada cloud infrastructure which is managed by Medstack to assure all provincial and federal privacy and security regulations are met. OPTT will not collect any identifiable personal information or IP addresses for privacy purposes. OPTT will only collect anonymized metadata to improve its service quality and provide advanced analytics to the clinician team. All data is encrypted by OPTT and no employee has direct access to patient data. All encrypted backups are kept in the S3 storage that is dedicated to Queen's University.
Study:
NCT04476667
Study Brief:
Online Delivery of Psychotherapy, Tailored to Patients' Suffering from Mental Health Problems Due to COVID-19