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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT05326802
Description:
TMRW and Dudley Associates (DA) will keep a master list containing personal identifiers and responses separate from data forms (paper and electronic) that have only analyzed results. The master list will be on a separate computer at DA. This form of data is considered "coded" not de-identified. Since the data can be re-linked to identifiers, it is coded. Only after the key to the code or the Master List is destroyed are the data considered de-identified. External investigators will not have access to these files
The password-protected data will be stored on TMRW's drives in addition to the PIs' computers that are backed up according to TMRW's company policies
The coded data with personally identifiable information of the survey participants will be stored as described above. The participants' personal identifiers and other data will be destroyed, and data will hence be de-identified 5 years after study completion in compliance with TMRW Data Classification and Handling Policy
Study:
NCT05326802
Study Brief:
The U.S. Embryologist Fatigue Study