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Welcome to the ClinicalTrials.gov Protocol Registration and Results System (PRS).
Jun 27, 2018 · The final rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) specifies requirements for submitting clinical trial information to ClinicalTrials.gov.
The risk to patients in this trial will be minimized by compliance with the eligibility criteria, close clinical monitoring and extensive guidance to the investigators, provided in the current version of the IB.
3 Introduction The data analyses outlined in this document are to support clinical study 1679-401-006. In this study, measurements will be made for plasma concentrations of dapsone, N-acetyl dapsone …
The hyperglycemia alarm will be set at 300 mg/dl. If this occurs, the nursing staff will assess clinical status and perform a POC glucose testing to confirm glucose values. If BG > 300 mg/dl, nursing staff …
Overview: The Baseline Characteristics module is a tabular summary of data for each demographic and base-line measure by arm or comparison group and for the entire population of participants in the …
In the event that the patient cannot return to the site for the study visit, every effort should be made to collect local safety blood collection tests and enter these into the eCRF, as well as assess for clinical …
ELABORATION OF DEFINITIONS OF RESPONSIBLE PARTY AND APPLICABLE CLINICAL TRIAL The elaboration of definitions of “Responsible Party” and “Applicable Clinical Trial” represent the …
To evaluate the clinical response in Cw6-negative and Cw6-positive patients treated with secukinumab 300 mg with respect to the Psoriasis Area Severity Index (PASI) 90 response rate after 16 weeks, …