North Carolina Agreement with Sponsor for Research on New Product or Process
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How to fill out Agreement With Sponsor For Research On New Product Or Process?
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FAQ
A person, company, institution, group, or organization that oversees or pays for a clinical trial and collects and analyzes the data. Also called trial sponsor.
1 The sponsor should obtain from the investigator/institution: (a) The name and address of the investigator's/institution's IRB/IEC. (b) A statement obtained from the IRB/IEC that it is organized and operates according to GCP and the applicable laws and regulations.
Essential documents are commonly referred to as regulatory documents. ICH GCP guidance defines essential documents as those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced.
The sponsor should obtain the name and address of the investigator/institution's IRB/IEC, a statement from the IRB/IEC that it uses GCP and adheres to applicable laws and regulations, a documented IRB/IEC approval/favorable opinion, and copies of the IRB/IEC reviewed documents, if requested.
The plan should describe the monitoring strategy, the monitoring responsibilities of all the parties involved, the various monitoring methods to be used, and the rationale for their use. The plan should also emphasize the monitoring of critical data and processes.
The essential documents for clinical trials are the following: Investigator's Brochure. Clinical Study Protocol. Subject Information and Informed Consent Form.
The sponsor should identify risks to critical trial processes and data. Risks should be considered at both the system level (e.g., standard operating procedures, computerized systems, personnel) and clinical trial level (e.g., trial design, data collection, informed consent process).
Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.
The sponsor should identify risks to critical trial processes and data. Risks should be considered at both the system level (e.g., standard operating procedures, computerized systems, personnel) and clinical trial level (e.g., trial design, data collection, informed consent process).
A clinical study report provides a clinical and statistical description, presentations and analyses of the completed study. The clinical study report should include an explanation of the critical design features, the plan, methods and conduct of the study, individual patient data and details of analytical methods.