Protocol Section

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: 2025-12-24 @ 1:18 PM
Ignite Modification Date: 2025-12-24 @ 1:18 PM
NCT ID: NCT05335395
Description: The project will produce rich longitudinal data from trial recruitment in the first 6 months of life through to the follow-up at age 30-32 months. The data will be curated into a single anonymised STATA. sta file, including newly generated participant ID and cluster codes, variable labels, and defined missing values. All identifiable data or data that may risk de-anonymisation (such as DOBs, personal names or cluster and village names) will be removed. Alongside the main study data file, codebooks and a detailed dataset guide will be produced to support correct and efficient data usage. Derived and computed variables and processing steps will be made available through annotated STATA analysis .do scripts. Videos and qualitative interview data, where anonymization is either not possible or there is a high risk of individuals being identified, will not be made publicly available. Suitably qualified researchers will be able to access these data under strict collaboration agreements.
Study: NCT05335395
Study Brief: SUNRISE CRT: Radio Intervention to Stimulate Early Child Development