Protocol Title definition
Protocol Title. A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Patients with Hormone Receptor-Positive Advanced Breast Cancer
Protocol Title. A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Post-menopausal Patients with Hormone Receptor-Positive Advanced Breast Cancer Company: Syndax Pharmaceuticals, Inc. ***
Protocol Title. A Phase III, Randomized, Double-Blind, parallel-design study comparing multiple doses of VI-0521 to Placebo and their single-agent phentermine and topiramate constituents for the Treatment of Obesity in Adults Protocol Number: OB-301 Indicate any amendments to this protocol by writing the Amendment Number and the Date of the Amendment in the space below. This page will be used to track the original protocol and its amendments. This is the original protocol if no amendment number is listed below. Section and/or Item Protocol Date Amendment 2, *** Change Effected *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Examples of Protocol Title in a sentence
Co-terminates with the Protocol Title: Annex V to protocol on cooperation in field of fossil energy R&D between U.S. Department of Energy - Ministry of Coal Industry of the People's Republic of China in the area of atmospheric fluidized bed (AFB) combustion information exchange Comment: EXCHANGE OF REPORTS AND DATA.
Protocol Title: This Study Order (“Study Order”) is an agreement between [Name of Alliance Partner or other CRO] (“CRO”), and [Name and address of Institution] (“Institution”) This Study Order is issued under the Master Clinical Study Agreement between Pfizer Inc and Institution with an effective date of December 1, 2015 (the “Master Agreement”).
Protocol Title has changed based on Protocol Amendment 1 dated 06- Dec-22.
Accordingly, Institution's engagement is subject to the terms and conditions of the Investigator Initiated Master Clinical Trial Research Agreement and the following: Study Drug: Protocol Title: ("Exhibit B" attached hereto and incorporated hereby) Principal Investigator: Confidentiality Period: five (5) years from the termination of this Addendum.
IQVIA, Institution and Investigator are parties to an agreement entitled Clinical Study Agreement effective as of 13 May 2019, as amended by Amendment # 1, dated 19 May 2023 (collectively referred to herein as the “Agreement”) with respect to the study with the Protocol Number and Protocol Title set forth above ( “Study”), and the parties desire to amend such Agreement; and IQVIA, Zdravotnické zařízení a Zkoušející jsou smluvními stranami Smlouvy uzavřené dne 13.
More Definitions of Protocol Title
Protocol Title. A Phase II Study of Humanized Monoclonal Antibody 3F8 (Hu3F8) with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma (attached hereto as Attachment 1) This Appendix A — Study Addendum (“Study Addendum”) is effective as of the date of the last party to sign (“Addendum Effective Date”), by and between Y-mAbs Therapeutics, Inc. a corporation with offices at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇ (“Company”), on the one hand; and MEMORIAL SLOAN KETTERING CANCER CENTER, a New York not-for-profit corporation with principal offices at ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇, on behalf of Memorial Hospital for Cancer and Allied Diseases, its Regional Network sites, MSK Alliance Clinical Trial Sites, and its Cancer Health Equity Research Program Sites (“MSK”), and on behalf of itself and the Investigator referenced herein on the other hand.
Protocol Title. „ ” Název protokolu: :„
Protocol Title. A Placebo-controlled, double-blind, Randomized, dose-finding phase II study on OMT-28 in Maintenance of Sinus rhythm after Electrical cardioversion in patients with persistent Atrial Fibrillation (PROMISE-AF) as amended from time to time and incorporated herein by reference (hereinafter referred to as the “Protocol”) Protocol Number: OMT28-C0201 Covance wishes to engage and Institution desires to participate in conducting the Study;
Protocol Title. One multicenter, randomized, open, phase III clinical study on SHR3680 combined with androgen deprived therapy (ADT) versus Bicalutamide combined with ADT in treatment of metastatic hormone-sensitive prostate cancer with high tumor load” Název Protokolu: „Multicentrické, randomizované, otevřené klinické hodnocení fáze III porovnávající přípravek SHR3680 v kombinaci s androgen deprivační terapií (ADT) oproti bikalutamidu v kombinaci s ADT při léčbě metastazujícího hormonálně senzitivního karcinomu prostaty s vysokou nádorovou zátěží“ Protocol Date: December 5, 2018 Datum Protokolu: 5. prosince 2018 Sponsor: Jiangsu Hengrui Medicine Co., Ltd. Zadavatel: Jiangsu Hengrui Medicine Co., Ltd. Country where Site is Conducting Study: Czech Republic Stát, ve kterém má sídlo Místo provádění klinického hodnocení, které provádí Studii: Česká republika Location where the study will be conducted: Department of Clinical Oncology, which is a division/part of the Institution Místo, kde bude prováděna Studie: Oddělení klinické onkologie, které je součástí/oddělením Zdravotnického zařízení Key Enrollment Date: 100 Calendar Days after Site Initiation Visit (being the date by which Site must enrol at least one (1) subject as more specifically set out in section 1.7 “Key Enrollment Date” below) Klíčové datum zařazení: 100 kalendářních dnů po Iniciační návštěvě Místa provádění klinického hodnocení (a to jakožto den, ke kterému je Místo provádění klinického hodnocení povinno zařadit minimálně jeden (1) subjekt, jak je dále podrobněji rozvedeno níže v odstavci 1.7 „Klíčové datum zařazení“) ECMT / EC / RA: ECMT: Etická komise FN Olomouc, I. P. ▇▇▇▇▇▇▇ ▇▇▇/▇, ▇▇▇ ▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ EC: Etická komise Nemocnice Na Homolce, ▇▇▇▇▇▇▇▇▇▇▇ ▇, ▇▇▇ ▇▇ ▇▇▇▇▇ ▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ RA: Státní ústav pro kontrolu léčiv, Šrobárova 48, 100 41 ▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ MEK / EK / SÚKL: MEK: Etická komise FN Olomouc, I. P. ▇▇▇▇▇▇▇ ▇▇▇/▇, ▇▇▇ ▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ LEK: Etická komise Nemocnice Na Homolce, Roentgenova 2, 150 30 ▇▇▇▇▇ ▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ SÚKL: Státní ústav pro kontrolu léčiv, Šrobárova 48, 100 41 ▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ The following additional definitions shall apply to this Agreement: Ve Smlouvě jsou použity následující smluvní definice: Protocol: the clinical protocol referenced above as it may be modified from time to time by the Sponsor (defined below). Protokol: klinický protokol, na který je odkázáno výše, a který může podléhat čas od času změnám provedeným Zadavatelem (v...
Protocol Title. A Phase 3, 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study with Open-label Extension of BLU-5937 in Adult Participants with Refractory Chronic Cough Including Unexplained Chronic Cough (CALM-2) Název Protokolu: 24-týdenní, randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení fáze III s paralelními rameny posuzující účinnost a bezpečnost přípravku BLU-5937 s otevřenou pokračovací fází u dospělých účastníků s refrakterním chronickým kašlem včetně nevysvětlitelného chronického kašle (CALM-2). / Protocol Date: 21 July 2022 Datum Protokolu: 21. července 2022 Sponsor: Bellus Health Inc., a wholly owned subsidiary of GSK plc Zadavatel: Bellus Health Inc., dceřiná společnost plně vlastněná společností GSK plc Country where Site is Conducting Study Czech Republic Stát, ve kterém má sídlo Místo provádění klinického hodnocení, které provádí Studii Česká republika Location where the study will be conducted: Department of Pulmonary Diseases and Tuberculosis, which is a division/part of the Institution Místo, kde bude prováděna Studie: Klinika plicních nemocí a tuberkulózy, která je součástí/oddělením Zdravotnického zařízení Key Enrolment Date: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Klíčové datum zařazení: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx ECMT / EC / RA CEC/LEC: Fakultní nemocnice Olomouc, ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇/▇, ▇▇▇ ▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ RA: Státní ústav pro kontrolu léčiv, ▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇ ▇▇ ▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ MEK / EK / SÚKL MEK / LEK: Fakultní nemocnice Olomouc, Zdravotníků 248/7, 779 00 Olomouc, Česká republika SÚKL: Státní ústav pro kontrolu léčiv, ▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇ ▇▇ ▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ The following additional definitions shall apply to this Agreement: Ve Smlouvě jsou použity následující smluvní definice: Protocol: the clinical protocol referenced above as it may be modified from time to time by the Sponsor (defined below). Protokol: klinický protokol, na který je odkázáno výše, a který může podléhat čas od času změnám provedeným Zadavatel...
Protocol Title. A Phase III Randomized, Double-Blind, Placebo controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in Adults with Obesity-Related Co-Morbid Conditions Protocol Number: OB-303 Indicate any amendments to this protocol by writing the Amendment Number and the Date of the Amendment in the space below. This page will be used to track the original protocol and its amendments. This is the original protocol if no amendment number is listed below. Section and/or Item Protocol Date Amendment 2, *** Change Effected
Protocol Title. A Double-Blind, Randomized, Placebo-Controlled Study Of The Safety And Efficacy Of Three Dose Regimens Of Oral Aliminase In The Treatment Of Active Ulcerative Colitis Protocol No. 9084 Study Specifications Protocol Number 9084 Carrington Contact Kenneth (Bill) Yates, D.V.M. ▇▇▇ ▇▇armaco Contact ▇▇▇ty ▇▇▇le▇, ▇▇rector, Business Development ▇▇▇▇▇▇nd Aliminase Indication Active Ulcerative Colitis Program Phase II Study Design Double-Blind, Randomized, Placebo- Controlled, Safety & Efficacy Study Number of Screened Patients 350 Number of Enrolled Patients 280 Number of Completed Patients 280 Number of Investigators 40 Investigators Meeting Yes, 94 attending Approximate Number of Qualification Visits 40 Type of IRB Local & Central Number of Initiation Visits 40 Approximate Number Patients Per Site 9 Enrollment Period 7.7 Months Enrollment Rate .9 Patients/Month Duration of Patient Participation 1.5 Months Interim Monitoring Frequency Q6-8 Weeks Number of Interim Visits (excluding closeout visits) 7 Per Site (280 total) Number of Close Out Visits 40 Estimated Number of Case Report Form (CRF) Pages Per Patient 26 Estimated Number of Unique Pages Per CRF 16 Estimated Number of CRF Pages for Data Entry 7,280 Number of Statistical Tables 38 Number of Statistical Listings 26 Number of Statistical Figures 2 Deliverable Clinical Statistical Report PROJECT TIMELINES Project Milestone Periods The program timeline is summarized in the table below. Activity Study Initiation Jan. 1, 1999 - Mar. 30, 1999 Investigator Meeting February 1999 Enrollment Period * Mar. 31, 1999 - Nov. 25, 1999 Treatment Period Mar. 31, 1999 - Jan. 10, 1999 Study Closeout Jan. 11, 1999 - Feb. 10, 2000 Biostatistics Feb. 11, 2000 - Mar. 25, 2000 Clinical Statistical Report Mar. 26, 1999 - May 5, 2000 Total PPD Pharmaco Commitment -16.2 Months * Any extension to the enrollment period will result in contract modifications. STATEMENT OF SERVICES The following lists the specific responsibilities assigned to Carrington () or PPD Pharmaco ().