Protocol Number. 1002-048 Protocol Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with Elevated LDL-C Protocol Date: 18 January 2017 Sponsor: Esperion Therapeutics, Inc. Country where Institution is Conducting Study Czech Republic Location where the study will be conducted: Kardiologická ambulance, 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 1.7 “Key Enrollment Date” below) ECMT / EC / RA ECMT: Ethics Committee Fakultni nemocnice v Motole V Uvalu 84 150 06 Xxxxx 0 Xxxxx Xxxxxxxx; Mgr. xxxxxxxxxxxxx Etická komise Nemocnice Havlíčkův Brod Husova 2624 580 22 Havlíčkův Brod RA: State Institute for Drug Control, Xxxxxxxxx 00, 000 00 Xxxxx 00 Xxxxx Xxxxxxxx Investigator name, (the “Investigator”) xxxxxxxxxxxxx Číslo Protokolu: 1002-048 Název Protokolu: Randomizované, dvojitě zaslepené, placebem kontrolované multicentrické klinické hodnocení, s paralelními skupinami, posuzující účinnost a bezpečnost kyseliny bempedové (ETC 1002) 180 mg denně jako doplňku k léčbě ezetimibem u pacientů se zvýšenou hladinou LDL-C Datum Protokolu: 18. 1. 2017 Zadavatel: Esperion Therapeutics, Inc. Stát, ve kterém má sídlo Zdravotnické zařízení, které provádí Studii Česká republika Místo, kde bude prováděna Studie: Kardiologická ambulance, 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 je Místo provádění klinického hodnocení povinno zařadit minimálně jeden (1) subjekt, jak je dále podrobněji rozvedeno níže v odstavci 1.7 “Klíčové datum zařazení”) MEK / EK / SÚKL MEK: Etická komise Fakultní nemocnice v Motole V Úvalu 84 150 06 Xxxxx 0 Xxxxx xxxxxxxxx; xxxxxxxxxxxxx Etická komise Nemocnice Havlíčkův Brod Husova 2624 580 22 Havlíčkův Brod SÚKL: Státní ústav pro kontrolu léčiv, Šrobárova 48, 100 41 Xxxxx 00 Xxxxx xxxxxxxxx Jméno zkoušejícího, ( “Zkoušející”) xxxxxxxxxxxxx The following additional definitions shall apply to this Agreement: Ve Smlouvě jsou použity následující smluvní definice:
Protocol Number. IHLOSAPOC1 Site: Xxxxxx Health Medicines Australia Standard CTRA 8 March 2017 (revised) Page 14 of 38
Protocol Number. IHLOSAPOC1 Site: Xxxxxx Health
Examples of Protocol Number in a sentence
Recipient: [Insert Name of NHS/HSC Recipient] Recipient Address: [Insert postal Address of Recipient] Email: [insert generic email address for Research Support Department] Date [DD/MM/YYYY] To whom it may concern Regarding Study Title: [insert full study title] Protocol Number (or other reference): [insert protocol number or reference as applicable] Company: [insert name] [(Option 1): The Company has not yet identified any potential Investigators.
More Definitions of Protocol Number
Protocol Number. IHLOSAPOC1Site: University of Western Australia_FINAL Medicines Australia Standard CTRA 8 March 2017 (revised) Page 27 of 32 Schedule 3 Form of Indemnity for Clinical Trials The Sponsor agrees to execute and deliver to the Institution, as necessary, an indemnity in the form of the Medicines Australia Standard Form of Indemnity for Clinical Trials without amendment. Indemnity for Clinical Trials; HREC Review Only and Standard Forms have been provided as separate documents.
Protocol Number. IHLOSAOLE1Site: Xxxxxx Health Schedule 7 Special Conditions There are no special conditions. This page is blank.
Protocol Number. IHLOSAPOC1 Site: Xxxxxx Health Medicines Australia Standard CTRA 8 March 2017 (revised) Page 1 of 38 This agreement is made between the Sponsor and Institution Purpose of the Agreement According to this Agreement:
Protocol Number. IHLOSAPOC1 Site: Xxxxxx Health In witness hereof, the parties have caused this Agreement to be executed as of respective dates written below. Signed on behalf of the Sponsor Signed: Name: Position: Date: Signed on behalf of the Institution Signed: Name: Position: Date: The Principal Investigator acknowledges this Agreement and understands the obligations it imposes. Acknowledged by the Principal Investigator Signed: Name: Position: Date:
Protocol Number. IHLOSAPOC1 Site: Xxxxxx Health Schedule 1 Key Information Study Name: Dose finding crossover trial investigating the effect of dronabinol combined with acetazolamide on Apnoea Hypopnea Index (AHi) in adults with obstructive sleep apnoea (OSA) Study Site/s: The Xxxxxx Hospital Target number of Study Participants: Minimum: 12 Maximum: 12
Protocol Number. IHLOSAPOC1 Site: Xxxxxx Health A Pharmacy Close Out Fee, a one-time fee, will be payable upon the final close out visit, after all remaining or used Investigational Product as either been returned to the sponsor or destroyed upon written notification from the sponsor, and all pharmacy files have been returned to the site for archiving. This fee will be payable upon invoice, no later than 30 days post close out visit. [***] Pathology Activities [***] A Protocol review and SSA completion Fee, a one-time fee, will be payable upon completion of the Site Initiation Visit and upon invoice. [***] An Establishment Fee, a one-time fee for the establishment of the trial, upon Site Initiation Visit and payable upon receipt of an invoice. [***] Test or service fee [***] Standard HAEM panel [***] Standard BIOCHEMISTRY panel [***] Urinalysis [***] Urine pregnancy test [***] Specimen shipping, per shipment [***] Health Information Services Retrieval fee for paper medical records (per volume) from onsite storage [***] Retrieval fee for paper medical records (per volume) from external storage [***] Registration Fee, per participant [***] Permanent retention (per volume) of medical records for research [***] ICD10 Diagnosis database participant information search (per search) [***]
Protocol Number. IHLOSAPOC1 Site: Xxxxxx Health Medicines Australia Standard CTRA 8 March 2017 (revised) Page 26 of 38 The notification of all payments made under this Agreement will be accompanied with documentation of the calculation of each payment. The documentation will specify: ● The Human Research Ethics Committee (HREC) project number ● The Principal Investigator’s name; ● What the payment is being made for: ● The number of participants who have completed particular milestones; and ● Detail of any partial payments, or any other information relevant to the calculation of the payment by Neuroscience Trials Australia. * Copies of all payment notices will be sent to the attention of the Management Accountant - Research at the following address: