Design Module

Design Module

The Design Module contains detailed information about the study design, including study type, allocation methods, intervention models, masking information, primary purpose, enrollment details, and biospecimen information. This module provides essential details about how the clinical trial is structured and conducted.

Design Module path is as follows:

Study -> Protocol Section -> Design Module

Design Module


Ignite Creation Date: 2025-12-24 @ 4:25 PM
Ignite Modification Date: 2025-12-24 @ 4:25 PM
NCT ID: NCT01544166
Study Type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Primary Purpose: DIAGNOSTIC
Study: NCT01544166
Study Brief: Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)
Protocol Section: NCT01544166
Bio Specs (If Any):
Design Masking Infos (If Any):

Design Masking Infos

Design Masking Brief View
None View
Design Observational Models (If Any):
Design Time Perspectives (If Any):
Design Who Masked (If Any):
Enrollment Infos (If Any):

Enrollment Infos

Enrollment Type Enrollment Count View
ACTUAL 44 View
Expanded Access Types (If Any):
Phases (If Any):

Phases

Phase Brief Phase Text View
None PHASE1 View