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 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT03143361
Description:
Data will be collected into a dedicated datasheet with predefined variables. Each patient enrolled in the Registry will be anonymized by the generation of a code consisting of the initials of the enrolling Centre (2 letters), the initial of name (1 letter) and surname (1 letter), and the date of birth (dd.mm.yyyy) (e.g. Mr. John Smith, born on February 18th, 1953; enrolled in London = LOJS18021953). It is responsibility of the E-AVR Steering Committee local member to generate the sequence to maintain anonymized the entire set of data.
Storage, analysis and auditing of data will be accomplished by an independent Central Core Laboratory. Auditing of the dataset will be performed every six months by checking the data of a minimum of 40% of the patients. Incomplete or contraddictory data with patient identification code will be sent from Central Core Statistical Lab to the E-AVR Steering Committee local member for further data checking, review, correction and merging.
Study:
NCT03143361
Study Brief:
Prospective European Multicenter Study on Aortic Valve Replacement: (E-AVR Registry)