Bold code in the Clinical Trial Agreement Template

Aug 6th, 2022
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Fees of Clinical Trial Approval in India The basic fee is 3,00,000 Rupees for Phase I (human) clinical trials. 2,00,000 Rupees for Phase II (exploratory) clinical trials. 2,00,000 Rupees for Phase III (confirmatory) clinical trials.
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.
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.
Step 1: Approval from the Drugs Controller General, India. Step 2: Permission from particular Ethics Committee where the clinical study is designed. Step 3: Compulsory registration on the ICMR website .ctri.in.
Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI.
A Clinical Trial Agreement (CTA) is a legally binding agreement that manages the relationship between the sponsor that may be providing the study drug or device, the financial support and /or proprietary information and the institution that may be providing data and/or results, publication and input into further
The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.
The essential documents for clinical trials are the following: Investigators Brochure. Clinical Study Protocol. Subject Information and Informed Consent Form.

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