Enter URL in the Clinical Trial Agreement Template

Aug 6th, 2022
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How to enter URL in the Clinical Trial Agreement Template

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Stacey Arnold: Hello, my name is Stacey Arnold, and I am a contractor with ICF working as a Results Team Subject-Matter Expert for clinicaltrials.gov. Clinicaltrials.gov is a part of the National Center for Biotechnology Information in the National Library of Medicine at the National Institutes of Health. Today, I will be discussing registering and reporting results to clinicaltrials.gov. During this presentation, I will cover the following topics. First, I will provide a rationale for registering clinical tries and reporting summary level results to clinicaltrials.gov. Next, I will give an overview of registration and results reporting. Then, I will review an online training platform that has been developed to facilitate the registration and reporting processes, the PRS Guided Tutorials. And finally, I will describe an effort that is underway to modernize the clinicaltrials.gov website and PRS database. Why register clinical trials and report summary level results? One of the most

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Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI.
WHO REVIEWS AND APPROVES A CLINICAL TRIAL PROTOCOL? All protocols for privately sponsored or federally funded trials must be reviewed by a third-party review board, called an institutional review board (IRB) or an independent ethics committee (IEC).
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 partys responsibilities and obligations for the clinical trial.
Key Distinctions Between CTAs and INDs One primary distinction to note between a CTA and an IND submission is that the CTA is protocol-specific, while the IND is product-specific. Once the CTA is submitted, the EU requires a new CTA for any new protocols amended.
Overall, the main difference between a CTA and an In-House CRA is the level of experience and responsibility. CTAs typically provide more administrative support, while In-House CRAs are more involved in the oversight and management of clinical trials.
Definition. A clinical trial agreement (CTA) or clinical study agreement (CSA) is a legally binding agreement that governs the conduct of a particular study and sets forth the obligations of each party to the agreement.

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