Medicines Australia CTRA definition

Medicines Australia CTRA. Contract Research Organisation acting as the Local Sponsor This agreement is to be used where a Contract Research Organisation acts as, and assumes all of the responsibilities of, a local commercial sponsor. The body of this Agreement (that is from the following page to the execution clauses) is intended to be identical to the standard form a copy of which is located at xxxx://xxxxxxxxxxxxxxxxxx.xxx.xx/xxxxxx-xxxxxxxxxxx/xxxxxxxx-xxxxxx/xxxxxxxx-xxxxxx-xxxxxxxx-xxxxxxxxxx. Any textual change to the body of this Agreement is to be ignored, and reference instead had to the standard form, as amended by Schedule 7 by way of Special Conditions. Details of the parties Name of Institution: Address: ABN: Contact for Notices: Fax for Notices: Phone Number: Name of Local Sponsor: Address: ABN: Contact for Notices: Fax for Notices: Phone Number: Study name: Protocol Number: Date of Agreement: This agreement is made between the Local Sponsor and Institution Purpose of the agreement The Study has been developed by the Organisation. In order to conduct the Study in Australia, the Organisation has engaged the Local Sponsor to act as Local Sponsor. The Local Sponsor is responsible for the conduct of the Study in Australia, including making payment to the Institution or Principal Investigator (as the case may be) for the conduct of the Study. The Institution, through the Principal Investigator, is responsible for the conduct of the Study at the Study Site(s) which is/are under the control of the Institution. The Study will be conducted on the terms and conditions set out below.
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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 This agreement is to be used where a Contract Research Organisation acts as, and assumes all of the responsibilities of, a local commercial sponsor. The body of this Agreement (that is from the following page to the execution clauses) is intended to be identical to the standard form a copy of which is located at xxxx://xxxxxxxxxxxxxxxxxx.xxx.xx/xxxxxx-xxxxxxxxxxx/xxxxxxxx-xxxxxx/xxxxxxxx-xxxxxx-xxxxxxxx-xxxxxxxxxx. Any textual change to the body of this Agreement is to be ignored, and reference instead had to the standard form, as amended by Schedule 7 by way of Special Conditions. Details of the parties Name of Institution: Monash Health Address: 000 Xxxxxxx Xxxx, Xxxxxxx Xxxxxxxx, 3168 ABN: 00 000 000 000 Contact for Notices: Fax for Notices: Phone Number: Name of Administering Institution: Monash University Address: Wellington Road, Xxxxxxx, Xxxxxxxx, 3800 ABN: 00 000 000 000 Contact for Notices: Phone Number: Name of Local Sponsor: Address: ABN: Contact for Notices: Fax for Notices: Phone Number: Study name: Protocol Number: Date of Agreement: This agreement is made between the Local Sponsor and Institution Purpose of the agreement The Study has been developed by the Organisation. In order to conduct the Study in Australia, the Organisation has engaged the Local Sponsor to act as Local Sponsor. The Local Sponsor is responsible for the conduct of the Study in Australia, including making payment to the Institution or Principal Investigator (as the case may be) for the conduct of the Study. The Institution, through the Principal Investigator, is responsible for the conduct of the Study at the Study Site(s) which is/are under the control of the Institution. The Study will be conducted on the terms and conditions set out below.
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Examples of Medicines Australia CTRA in a sentence

  • Schedule 7 in the Medicines Australia CTRA (Forms A, B & D) and Schedule 4 of the CRG CTRA (Form C) are used specifically for this purpose.

  • Contract Research Organisation CTRA: Where the Contract Research Organisation (CRO) has accepted all the roles of the sponsor the “Clinical Trial Research Agreement Medicines Australia CTRA: Contract Research Organisation acting as the Local Sponsor” should be used.

  • They must also liaise with the emergency services when an incident occurs, and should be asked to provide, wherever possible in advance, information required for rescue work and fire-fighting purposes (e.g. in respect of any special risks involved in the premises), so as to maximise the safety and efficiency of such work.It is unfortunate that two very distinct requirements have been brought together under a single article in this way.

  • 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.

  • Eventually, as you continue to learn doctrine, you will construct the frame of reference that enables you to understandand accept these doctrines.

  • 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.

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

  • The Chairperson will determine if the complaint lacks merit and/or if it can be disposed of by mutual consent of the parties involved on a basis acceptable to the Chairperson.

  • 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.

  • Yes No N/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.


More Definitions of Medicines Australia CTRA

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

  • Australia means the Commonwealth of Australia.

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

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  • French Language Services Act means the Ontario French Language Services Act, R.S.O. 1990, Chapter F.32, as amended from time to time;

  • 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.

  • EUWA means the European Union (Withdrawal) Act 2018;