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 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT06599593
Description:
Informed consent documents for the proposed aims will include explicit language informing the participant's caregiver(s) that residual biological specimens, including DNA, may be stored in a biorepository for other scientific investigators. The informed consent documents will contain language permitting secondary use with broad data sharing under controlled access with general use restrictions in GitHub and OSF. Any data shared will be de-identified. Participants will not be contacted or re-consented for future sharing or accessing data through repositories.
Privacy and confidentiality protections will be consistent with applicable local laws in Burkina Faso. Data will be de-identified by removing all 18 HIPAA identifiers prior to sharing. All data sharing plans will be reviewed and approved by the respective institutional review boards at all participating institutions and will be reviewed during the informed consent process with caregivers. Caregivers may opt out of data sharing, for
Study:
NCT06599593
Study Brief:
Leveraging the Seasonal Malaria Chemoprevention Platform to Address Malaria and Malnutrition