Rhode Island 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
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 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.
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).
Required Elements of a Data and Safety Monitoring PlanA brief description of the study design (e.g., interventions, procedures, tests and scans, biospecimen collection, interviews and focus groups, study visits)Primary and secondary outcome measures/endpoints.Sample size and target population.More items...
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 essential documents for clinical trials are the following: Investigator's Brochure. Clinical Study Protocol. Subject Information and Informed Consent Form.
5.18.1 Purpose The purposes of trial monitoring are to verify that: (a) The rights and well-being of human subjects are protected. (b) The reported trial data are accurate, complete, and verifiable from source documents.
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.
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).
