Bold phone in the Clinical Trial Agreement Template

Aug 6th, 2022
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How to bold phone in the Clinical Trial Agreement Template

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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.
The Drugs Controller General of India (DCGI) is an official of the CDSCO who is the final regulatory authority for the approval of clinical trials in the country.
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).
Experts in writing clinical trial protocols will typically be medical writers with several years of experience writing for a contract research organization (CRO), pharmaceutical company, or biotechnology company. They usually have a PharmD, MD, or a Masters or Ph. D. degree in an allied scientific field.
In ance with the CanadaFDA, Health Canada (HC) reviews, evaluates, and approves applications for clinical trials using authorized therapeutic products. HC also approves the sale or importation of drugs for use in clinical trials. (See the Manufacturing Import section for additional information on importation.)
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.
The members of the review board can include healthcare professionals, scientists, and non-healthcare professionals. IRBs/IECs are responsible for evaluating the clinical trial protocol and determining whether it is medically, legally, and ethically acceptable.
The essential documents for clinical trials are the following: Investigators Brochure. Clinical Study Protocol. Subject Information and Informed Consent Form.

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