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 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT07194369
Description:
Regarding anonymity of patient information, the only documents to contain the patient's name will be the consent form and a sequentially numbered list that will be completed at recruitment that the PI will store to keep track of patients in the study. All data will be de-identified, no personal information (for example name and file number) will be recorded on any of the other study documents.
Confidentiality will be ensured by the PI storing all paper documents in lever-arch files in a secure location that only the PI and research assistant has access to. The sequentially numbered list will be stored electronically in a password controlled online folder that only the PI has access to. Personal information will not be shared without express patient permission.
Study:
NCT07194369
Study Brief:
Validation of the Setswana Translated Quality of Recovery Questionnaire in Orthopaedic Patients at a Tertiary Hospital in South Africa