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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.

For content and formatting of the manuscript, writers need to carefully follow the instructions for authors as stipulated by the target journal. In general, a manuscript based on a clinical trial is presented sequentially in four sections: Introduction, Methods, Results, and Discussion (IMRAD).

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.

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.

Clinical trials are research studies that test a medical, surgical, or behavioral intervention in people. These trials are the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device (for example, a pacemaker), is safe and effective in people.

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 ...

Risks versus benefits You could get a treatment that's not available outside of the trial. This treatment might be safer or work better than current options. This may increase the number of your treatment options. You may feel more control by taking a more active role in your health care.