Maryland 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 Clinical Monitoring Plan (CMP) is created for each study that will be monitored. The information provided below serves as a guideline for developing the clinical site monitoring plan. The levels of complexity are based on human subject risk, size, nature, and complexity of the study.
21 CFR 312.60 An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement (the FDA's 1572 form), the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the
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.
This is a formal written agreement between an institution conducting research and an independent investigator who is collaborating on the research, by which the institution agrees to extend its Federalwide Assurance (FWA) about human subjects research to the individual, and by which the independent investigator agrees
Generally, a sponsor is responsible for: Selecting the investigator(s) Providing investigator(s) with the necessary information to conduct the clinical trial. Ensuring proper monitoring of the clinical study.
The monitoring plan is the document that details the monitoring policies and procedures, and the proposed frequency of on-site monitoring visits across the trial sites, for a particular trial.
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.
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...
Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols
Sponsored Research Agreement (SRA) An agreement (which may be classified as a grant, contract or cooperative agreement) under which one party (Sponsor) provides funding to a second party (Awardee) to support the performance of a specified research project or related activity (e.g. conference, policy development).