Protocol Title Sample Clauses
The "Protocol Title" clause serves to formally identify the specific research protocol or study that the agreement pertains to. It typically includes the official name or title of the protocol, and may reference a protocol number or version to ensure precision. By clearly stating the protocol title, this clause eliminates ambiguity about which study the agreement covers, ensuring all parties are aligned on the scope and subject of their collaboration.
Protocol Title. A Phase 2a, Randomised, Double- Blind, Placebo- Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate Disease Activity Protocol Date: 25 Feb 2016 Sponsor: TOPIVERT Pharma Limited Country where Institution is Conducting Study Czech Republic Location where the study will be conducted: Department of Internal Medicine, which is a division/part of the Institution Místo, kde bude prováděna Studie: Interní oddělení, která je součástí/oddělením Zdravotnického zařízení Klíčové datum zařazení: 100 kalendářních dnů po Iniciační návštěvě Místa provádění klinického hodnocení (a to jakožto den, ke kterému ▇▇ ▇▇▇▇▇ provádění klinického hodnocení povinno zařadit minimálně jeden (1) subjekt, jak ▇▇ ▇▇▇▇ podrobněji rozvedeno níže v odstavci 1.7 “Klíčové datum zařazení”) 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) MEC: Etická komise Fakultní nemocnice ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇/▇▇ 100 34 ▇▇▇▇▇ ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ MEK: Etická komise Fakultní nemocnice ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇/▇▇ 100 34 ▇▇▇▇▇ ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ECMT / EC / RA LEC: Etická komise Nemocnice Na ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇ ▇▇▇ ▇▇ ▇▇▇▇▇ ▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ MEK / EK / SÚKL LEK: Etická komise Nemocnice Na ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇ ▇▇▇ ▇▇ ▇▇▇▇▇ ▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ Contact person: Kontaktní osoba: RA: Státní ústav pro kontrolu léčiv Šrobárova 48 100 41 ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ SÚKL: Státní ústav pro kontrolu léčiv Šrobárova 48 100 41 ▇▇▇▇▇ ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ Investigator name (the “Investigator”) Jméno zkoušejícího (“Zkoušející”) The following additional definitions shall apply to this Agreement: Ve Smlouvě jsou použity následující smluvní definice: Case Report Form or CRF: case report form (paper or electronic) to be used by Site to record all of the Protocol-required information to be reported to Sponsor on each Study Subject (defined below). Formuláře pro záznamy o subjektech hodnocení (Case Report Form) nebo CRF: formulář pro záznamy o subjektech hodnocení (v listinné či elektronické podobě) bude používán Místem provádění klinického hodnocení za účelem záznamu veškerých informací požadovaných Protokolem, které podléhají oznamování Study: the clinical trial that is to be performed in accordance with this Agreement and the Protocol for pu...
Protocol Title. A master protocol to test the impact of discontinuing chronic therapies in people with cystic fibrosis on highly effective CFTR modulator therapy (SIMPLIFY) Protocol Date: February 14, 2020 2.1 Risk / Benefit Assessment 8 3.1 Study Overview 9 4.1 Primary Objective 11 4.2 Secondary Objectives 11 4.3 Exploratory Objectives 12 5.1 Primary Endpoint 12 5.2 Secondary Endpoints 12 6.1 Study Population 13 6.2 Eligibility Criteria at Screening 13 6.3 ELIGIBILITY CRITERIA AT RANDOMIZATION (VISIT 1, DAY 0) 15 6.4 ADDITIONAL ELIGIBILITY FOR MUCUS BIOLOGY AND CLEARANCE (MCC) 15 6.5 Study Specific Tolerance for Eligibility Criteria 16 6.6 Screen Fail Criteria 16
Protocol Title. A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib (AC220) Administered in Combination with Induction and Consolidation Chemotherapy, and Administered as Maintenance Therapy in Subjects 18 to 75 Years Old with Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia Název protokolu: Dvojitě zaslepená, placebem kontrolovaná studie fáze 3 přípravku Quizartinib (AC220) podávaného v kombinaci s indukční a konsolidační chemoterapií a jako udržovací léčba u pacientů ve věku 18 až 75 let s nově diagnostikovanou akutní myeloidní leukémií FLT3-ITD (+)
Protocol Title. (Insert Details) Sponsor: (Insert Details) Entered into by and between: (Hereinafter, “the Provider”) Registered Physical address of Provider: Wits Health Consortium (Pty) Ltd, a wholly owned company of the University of the Witwatersrand, Johannesburg 31 Princess of Wales Terrace, Parktown Johannesburg, 2193 Registered physical and postal address of Principal Investigator: Email: ▇▇▇@▇▇▇▇▇▇▇▇▇▇.▇▇.▇▇ Tel: Fax: Cell: Email: (Hereinafter, “the Recipient”) Registered physical and postal address of Recipient: Tel: Fax: Cell: Email: (Hereinafter, “the Human Research Ethics Committee”) Registered physical and postal address of Human Research Ethics Committee: University of the Witwatersrand Human Research Ethics Committee (Medical) Research Office, Senate House University of the Witwatersrand, ▇ ▇▇▇ ▇▇▇▇▇ Avenue, Braamfontein, Johannesburg, 2000 Tel: ▇▇▇ ▇▇▇ ▇▇▇▇ Fax: ▇▇▇ ▇▇▇ ▇▇▇▇ Email: ▇▇▇▇▇▇▇.▇▇▇▇▇@▇▇▇▇.▇▇.▇▇
Protocol Title. A Phase 3 Randomized, Double- masked, Multicenter Study to Compare the Efficacy and Safety of the Proposed Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients with Neovascular Age-Related Macular Degeneration (MAGELLAN- AMD) Číslo Protokolu: FYB203-03-01 Název Protokolu: Randomizované, dvojitě maskované, multicentrické klinické hodnocení fáze 3 porovnávající účinnost a bezpečnost přípravku FYB203 (navrhované biologické obdoby afliberceptu) v porovnání s přípravkem Eylea® u pacientů s věkem podmíněnou neovaskulární makulární degenerací (MAGELLAN-AMD)
Protocol Title. “A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS)” Protocol Date: 20 August 2020 Sponsor: Merck Healthcare KGaA Country where Site is Conducting Study Czech Republic Location where the study will be conducted: Neurology clinic, which is a division/part of the Institution 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 1.9 “Key Enrollment Date” below)
Protocol Title. (Insert Details) Sponsor: (Insert Details) Entered into by and between: (Hereinafter, “the Provider”) Registered Physical address of Provider: Wits Health Consortium (Pty) Ltd, a wholly owned company of the University of the Witwatersrand, Johannesburg ▇▇ ▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇ Registered physical and postal address of Principal Investigator: Email: ▇▇▇@▇▇▇▇▇▇▇▇▇▇.▇▇.▇▇ Tel: Fax: Cell: Email: (Hereinafter, “the Recipient”) Registered physical and postal address of Recipient: Tel: Fax: Cell: Email: (Hereinafter, “the Human Research Ethics Committee”) Registered physical and postal address of Human Research Ethics Committee: University of the Witwatersrand Human Research Ethics Committee (Medical) Research Office, Senate House University of the Witwatersrand, ▇ ▇▇▇ ▇▇▇▇▇ Avenue, Braamfontein, Johannesburg, 2000 Tel: ▇▇▇ ▇▇▇ ▇▇▇▇ Fax: ▇▇▇ ▇▇▇ ▇▇▇▇ Email: ▇▇▇@▇▇▇▇▇▇▇▇▇▇.▇▇.▇▇
Protocol Title. Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Hypertriglyceridemia (▇▇▇▇-3 Study)
Protocol Title. A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis
Protocol Title. A RANDOMIZED, DOUBLE- BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Název Protokolu: RANDOMIZOVANÉ, DVOJITĚ ZASLEPENÉ, DVOJITĚ MASKOVANÉ, AKTIVNĚ KONTROLOVANÉ, MULTICENTRICKÉ KLINICKÉ HODNOCENÍ FÁZE II O DVOU ČÁSTECH ZA ÚČELEM NÁHRADY STEROIDŮ PŘÍPRAVKEM IFX-1 U AKTIVNÍ GRANULOMATÓZY S POLYANGIITIDOU (GPA) A MIKROSKOPICKOU POLYANGIITIDOU (MPA) Protocol Date: 3 December 2018 Datum Protokolu: 3. prosince 2018 Sponsor: InflaRx GmbH Zadavatel: InflaRx GmbH Country where Institution is Conducting Study: Czech Republic Stát, ve kterém má ▇▇▇▇▇ Poskytovatel, který provádí Studii: Česká republika