Medicines Australia CTRA definition

Medicines Australia CTRA. Contract Research Organisation acting as the Local Sponsor Name of Institution: Name of Local Sponsor: Study name: This agreement is made between the Local Sponsor and Institution Purpose of the agreement
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Medicines Australia CTRA means the Medicines Australia Clinical Trial Research Agreement - Collaborative or Cooperative Research Group (CRG) Studies – Standard Form. The Medicines Australia CTRA can be accessed at xxxxx://xxxxxxxxxxxxxxxxxx.xxx.xx/policy/clinical-trials/clinical-trials-research-agreements.
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Medicines Australia CTRA. Contract Research Organisation acting as the Local Sponsor Name of Institution: Monash Health Name of Administering Institution: Monash University Name of Local Sponsor: Study name: This agreement is made between the Local Sponsor and Institution Purpose of the agreement
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Examples of Medicines Australia CTRA in a sentence

  • In the case of medicines, the Medicines Australia Clinical Trial Research Agreement - Collaborative or Cooperative Research Group (CRG) Studies – Standard Form (Medicines Australia CTRA) or substantially similar terms would fulfil this requirement.

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  • The indemnity is part of the standard Medicines Australia CTRA, therefore a separate form of indemnity does not need to be executed.For trials involving international sites, usually the CTRA will include a clause that states that each party is liable for its acts and omissions in relation to the conduct of the clinical trial.

  • Standard Medicines Australia CTRA for Commercially Sponsored Trials should be used when a pharmaceutical company is sponsoring a clinical trial that is to be conducted at site(s) under the control of Public Health Organisations.The sponsoring pharmaceutical company must be an Australian entity.

  • Standard Medicines Australia CTRA forms are available at <medicinesaustralia.com.au/issues-information/clinical-trials/clinical-trials-research-agreements>.

  • Standard Medicines Australia CTRA for Contract Research Organisations acting as the Local Sponsor should be used when a contract research organisation is Clinical Trial Research Agreements for use in NSW Public Health OrganisationsPROCEDURES sponsoring a clinical trial that is to be conducted at site(s) under the control of Public Health Organisations.The sponsoring contract research organisation must be an Australian entity.

  • The New Zealand Association of Clinical Research (NZACRes) has developed the sCTRA based upon the successfully implemented Medicines Australia CTRA standard template.

  • Is the Medicines Australia Standard Clinical Trial Agreement(s) signed by the sponsor attached?Yes NoN/A CTN/CTX formsFurther information on both the CTN and CTX schemes and completion of CTN/CTX forms is available at http://www.tga.gov.au/ct/index.htm IndemnityIf a standard Medicines Australia CTRA is used indemnity arrangements are covered in Schedule 3 of the CTRA.

  • Is the Medicines Australia Standard Clinical Trial Agreement(s) signed by the sponsor attached?Yes NoN/A CTN/CTX forms Further information on both the CTN and CTX schemes and completion of CTN/CTX forms is available at http://www.tga.gov.au/ct/index.htm IndemnityIf a standard Medicines Australia CTRA is used indemnity arrangements are covered in Schedule 3 of the CTRA.

  • The Ingham Institute endorses this policy with the exclusion of the requirement for the Eastern Seaboard Committee and the RGO reviews.The PI or delegate should review that the correct version of the Medicines Australia CTRA or SWSLHD Research Collaborative Agreement has been used for the clinical trial.


More Definitions of Medicines Australia CTRA

Medicines Australia CTRA. Contract Research Organisation acting as the Local Sponsor Details of the parties This agreement is made between the Local Sponsor and Institution Purpose of the agreement
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Medicines Australia CTRA means the current version of the Medicines Australia Clinical Trial Research Agreeme–t - Collaborative or Cooperative Research Group (CRG) Studies – Standard Form. The Medicines Australia CTRA can be accessed at xxxxx://xxx.xxxxxxxxxxxxxxxxxx.xxx.xx/policy/clinical-trials/clinical-trial-research-agreements/; MTAA CTRA means the Medical Technology Association of Australia standard terms and conditions for clinical trial investigation research agreements available at xxxxx://xxx.xxxx.xxx.xx/clinical-investigation-research-agreements; Protocol means the document which describes the objectives, design, methodology, statistical considerations and organisation of the Study, as such document may be amended from time to time and most recently approved by the Responsible HREC; Regulatory Authority or Regulatory Authorities means any body which has jurisdiction over the conduct of the Study at the Study Site and includes the Therapeutic Goods Administration, and any overseas regulatory authorities who may audit or require to be audited, any part of the Study or Study Materials; Responsible HREC means the Human Research Ethics Committee(s) reviewing the Study on behalf of the Institution; Study means that part of the Project to be conducted in accordance with the Protocol, which has been determined to be a Clinical Trial;
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Related to Medicines Australia CTRA

  • international application means an application filed under this Treaty;

  • Europe means the European Union, the European Economic Area and/or their member states, Switzerland and the United Kingdom.

  • Australia means the Commonwealth of Australia.

  • EUMA means the “SAP Delivered Support Agreement” which sets out the terms and conditions under which SAP provides support to End Users and which will be provided by SAP on a deal by deal basis.

  • EMEA means the European Medicines Evaluation Agency or any successor agency thereto.

  • India means the territory of India and includes the territorial sea and airspace above it, as well as any other maritime zone in which India has sovereign rights, other rights and jurisdiction, according to the Indian law and in accordance with international law, including the U.N. Convention on the Law of the Sea;

  • Nodal Ministry means the Ministry or Department identified pursuant to this order in respect of a particular item of goods or services or works.

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • Relevant Electric Retail Regulatory Authority means an entity that has jurisdiction over and establishes prices and policies for competition for providers of retail electric service to end- customers, such as the city council for a municipal utility, the governing board of a cooperative utility, the state public utility commission or any other such entity.

  • PLC means Programmable Logic Controller;

  • Municipal Finance Management Act means the Local Government: Municipal Finance Management Act, 2003 (Act No. 56 of 2003);

  • UK Listing Authority means the Financial Services Authority in its capacity as competent authority under the Financial Services and Markets Xxx 0000.

  • Motorway means a road specially designed and built for motor traffic, which does not serve properties bordering on it, and which:

  • Website of the European Central Bank means the website of the European Central Bank currently at http://www.ecb.europa.eu or any successor website officially designated by the European Central Bank.

  • International airport means an airport:

  • Health Canada means the section of the Canadian Government known as Health Canada and includes, among other departments, the Therapeutic Products Directorate and the Health Products and Food Branch Inspectorate;

  • Eurozone means the countries and territories listed in the Annex of Council Regulation (EC) No. 974/98 of 3 May 1998 on the introduction of the Euro, in its current version.

  • international carriage means any carriage in which, according to the contract of carriage, the place of departure and the place of destination are situated in two different States, or in a single State if, according to the contract of carriage or the scheduled itinerary, there is an intermediate port of call in another State;

  • EUWA means the European Union (Withdrawal) Act 2018, as amended.

  • Safety Management System means a systematic approach to managing safety, including the necessary organisational structures, accountabilities, policies and procedures;

  • EU GDPR means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC.

  • Motorsport Australia means the Confederation of Australia Motor Sport Ltd. trading as Motorsport Australia;

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • Asia means Afghanistan, Australia, Bangladesh, Bhutan, Brunei, Cambodia, China, Hong Kong, India, Indonesia, Japan, Kazakhstan, Kyrgyzstan, Laos, Macau, Malaysia, Maldives, Mongolia, Myanmar, Nepal, New Zealand, North Korea, Pakistan, the Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Tajikistan, Thailand, Timor-Leste, Turkmenistan, Uzbekistan, and Vietnam.

  • HKICL means Hong Kong Interbank Clearing Limited and its successors and assigns.

  • Major European Country means any of France, Germany, Italy, Spain or the United Kingdom.