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Overview Overview
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Delegation of authority Delegation of authority
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4.11 Contractual arrangements with research sites and contract research organizations
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Published:May 2013
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Overview
Pharmaceutical, biotech, and other research-based organizations (‘sponsors’) who act as study sponsors, often run studies in-house, but there is a trend towards increased outsourcing of this activity to clinical research organizations (CRO). Contractual arrangements must be in place for either eventuality. However, a different agreement is required depending on whether the contract is with the study site or the CRO. Therefore, clinical trial agreements (CTAgs) are used to contract with research sites to conduct clinical trials and service agreements (SAs) are used to contract with CROs.
While there are similarities between the two types of contracts, they reflect the different relationship that the sponsor has with both the research site and the CRO.
The difference between the contracts stems from 2 areas.
...
Agreement comparison
The differences between the agreements can be captured in considering the areas in Box 4.11.1.
Areas of comparison
...
Delegation of authority
Within a service agreement, it is necessary for the sponsor to delegate some authority to the CRO. However, within a CTAgs, the sponsor does not delegate authority.
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