Corporate / Contract Research Organisation Sample Clauses

Corporate / Contract Research Organisation. (CRO) CTA The CRO CTA is to be used when an international Organisation or an Australian company as owner of the investigational product engages a CRO to act as the Australian entity for the purposes of the CTN application. The CRO is then defined as the Local Sponsor and assumes all responsibilities and obligations that attach to a Local Sponsor. As the Local Sponsor, the CRO must: • Provide the Medicines Australia Form of Indemnity • Provide appropriate insurance. It is acceptable for the CRO to be a named additional insured under the International Organisation’s insurance policy – this will satisfy the obligation to provide appropriate insurance, provided the International Organisation’s insurance policy meets the specified level and coverage requirements. Schedule 7 Special Conditions • The standard terms of the CRO CTA should not be amended or altered in any way. • The CRO CTA provides for any Special Conditions to be included in Schedule 7. • There are no pre-approved Schedule 7 Special Conditions for the CRO CTA. Any Special Conditions proposed by a CRO should be carefully considered and, if they involve legal issues, legally reviewed. • Schedule 7 is not to be used to substantially amend the CTA or to introduce clauses which contradict or otherwise undermine the substantial provisions and spirit of the Agreement.
Sample 1
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Corporate / Contract Research Organisation. (CRO) CTRA The “Clinical Trial Research Agreement Medicine Australia CTRA: Contract Research Organisation acting as the Local Sponsor” agreement should be used when an international organisation or an Australian company as owner of the investigational product engages a Contract Research Organisation (CRO) to act as the Australian entity for the purposes of the CTN application. The CRO assumes all responsibilities and obligations that attach to a local sponsor of a commercially sponsored clinical trial. This includes providing:
Sample 1

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