Phase 1/2 Amendment 1Clinical Study Protocol • May 26th, 2018
Abbreviation Expression (Name) in full AE(s) adverse event(s) ALP alkaline phosphatase ALT alanine transaminase AMD age-related macular degeneration AST aspartate aminotransferase BCVA best corrected visual acuity BUN blood urea nitrogen CNV choroidal neo-vascularization CRF Case report form CST central subfield thickness dL deciliter eCRF(s) Electronic Case Report Form(s) EDC EC Electronic Data Capture Ethics Committee EKG electrocardiogram (= ECG) ESI(s) event(s) of special interest ETDRS Early Treatment of Diabetic Retinopathy Study FDA Food and Drug Administration FGF fibroblast growth factor GCP Good Clinical Practice GGT gamma-glutamyl transpeptidase GMPGLP Good Manufacturing PracticeGood Laboratory Practice hCG human chorionic gonadotropin HCT hematocrit HDL high density lipoprotein HGB hemoglobin HIPAA Health Insurance Portability and Accountability Act of 1996 ICF informed consent form ICH International Conference on Harmonization IEC Independent Ethics Committee IND Investiga
CLINICAL STUDY PROTOCOL Cover PageClinical Study Protocol • August 12th, 2019
Protocol No.: RACE3003 Protocol Date: 30 May 2017 Study Title: Multicenter, open-label, controlled, randomized clinical study to evaluate the efficacy and safety of Racecadotril in infants, children and adolescents with acute diarrhea IND No.: EudractCT No: NA NA Phase of Development: III Sponsor:Global Clinical Director Protocol Author (s) Abbott Laboratories GmbH
Protocol numberClinical Study Protocol • July 27th, 2021
CLINICAL STUDY PROTOCOLClinical Study Protocol • February 2nd, 2023
This document is a confidential communication of the Sponsor. Acceptance of this document constitutes the agreement by the recipient that no unpublished information contained within will be published or disclosed without prior written approval, except that this document may
Investigator Agreement: I have read the protocol and agree to conduct the study as outlined herein.Clinical Study Protocol • May 23rd, 2007
TITLE OF STUDY Serbian Smoking Reduction/Cessation Trial (2SRT) INVESTIGATORS & STUDY CENTERS Professor Robert Nilsson, Stockholm, International Coordinating InvestigatorDr Ruza Antic, Belgrade, Principal National Investigator Participants will be recruited at four centers in the city of Belgrade, Serbia PHASE OFDEVELOPMENT Phase III OBJECTIVES To assess the efficacy of a traditional Swedish smokeless tobacco product (“snus”) to reduce smoking among adult smokers in Serbia DESIGN Randomized, placebo-controlled, double-blind trial PLANNED SAMPLESIZE 500 DIAGNOSIS AND KEYSUBJECT SELECTION CRITERIA Males and females in good general health aged 20-65 years regularlysmoking >10 cigarettes per day for more than 1 year, who are motivated to reduce or quit smoking TREATMENTS 1. Traditional, low-nitrosamine Swedish snus in 0.5 or 1.0 g sachets ad libitum2. Placebo snus (without tobacco or nicotine) MAIN PARAMETERS OF EFFICACY Primary end-point:• “Smoking reduction” at 24 weeks, defined as a sel
CLINICAL STUDY PROTOCOLClinical Study Protocol • January 30th, 2019
STUDY TITLE: An Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of Eteplirsen in Patients with Advanced Stage Duchenne Muscular Dystrophy
