Adopt Signed Clinical Trial Agreement Template For Free

CTAs are one of several key documents that govern the conduct of clinical trials. A CTA serves as a legally binding contract between a sponsor, site, and researcher, and outlines each party's responsibilities and obligations for the clinical trial.

Summary. This master clinical trial agreement can be used as a starting point for negotiating and drafting an agreement between a drug or medical device manufacturer (sponsor) and an institution taking on responsibility for conducting a clinical trial on behalf of the sponsor.

Parties to clinical trial or study agreements include the participating site, the study sponsor, and/or the relevant clinical research organization (CRO).

In the case of industry sponsored studies (such as regulatory studies for investigational new drugs or devices, post-market, observational or certain registry studies), the sponsor or its clinical research organization will provide an initial draft of the CTA.

To hire a freelance clinical trial protocol writer, the fee generally ranges from 40?100 USD per hour depending on the required skillset and the level of experience necessary.

A CTA 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 and possibility of ...

Ing to the ICH Good Clinical Practice guidelines, a protocol should include the following topics: Title Page (General Information) Background Information. Objectives/Purpose. Study Design. Selection and Exclusion of Subjects. Treatment of Subjects. Assessment of Efficacy. Assessment of Safety.

CTAs are one of several key documents that govern the conduct of clinical trials. A CTA serves as a legally binding contract between a sponsor, site, and researcher, and outlines each party's responsibilities and obligations for the clinical trial.