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Back To News. CTAs are one of several key documents that govern the conduct of clinical trials. They serve as a legally binding contract between a sponsor, site, and researcher, and outline each party's responsibilities and obligations for the clinical trial.
Parties to clinical trial or study agreements include the participating site, the study sponsor, and/or the relevant clinical research organization (CRO).
A Contract Teaming Arrangement (CTA) is an arrangement between two or more GSA Schedule contracts to work together to meet an agency's requirements.
The Office of Sponsored Programs (OSP) is responsible for reviewing, negotiating and legally executing agreements from external funding sources.
Sponsors may transfer any or all of their many tasks and obligations relating to clinical trials to Contract Research Organizations (CROs). This ability to delegate through a Transfer of Regulatory Obligations (TORO) brings with it a range of advantages to the Sponsor.
Site Initiation Visit (SIV) The on-site meeting designed to prepare the study team for conducting the study. The meeting includes (at a minimum) the PI, other investigators, site study coordinator, other site staff assuming study responsibilities, and data management representative.
We can read, includes: General information, background information, objectives / purpose, trial design , selections and withdrawal of subjects, treatment subjects, assessment of safety and efficacy.
A clinical trials agreement should describe and acknowledge responsibilities, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms, indemnification and or insurance, subject injury coverage, guidelines for dispute resolution, grounds for termination of contract
CTAs are one of several key documents that govern the conduct of clinical trials. They serve as a legally binding contract between a sponsor, site, and researcher, and outline each party's responsibilities and obligations for the clinical trial.
A master clinical trial agreement (MCTA) is a contract between a sponsor and a site that applies to multiple studies. It may or may not apply to all studies that site conducts for that sponsor.