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Click ‘Get Form’ to open the MON FORM 003 in the editor.
Begin by entering the 'Study Name' and details of the 'Monitor(s)' and 'Investigator'. Ensure all names and titles are accurately filled in.
In the 'RECRUITMENT' section, provide anticipated enrollment dates and numbers. This includes the first patient enrollment date and estimated completion date.
Complete the 'INVESTIGATOR AND STAFF' section by answering questions regarding qualifications, training, and experience. Attach necessary documents like CVs where required.
Proceed to 'FACILITY/OPERATIONS' to confirm that all facilities meet study requirements. Document any licenses or certifications needed.
Fill out the 'STUDY PATIENT POPULATION' section, ensuring you discuss inclusion/exclusion criteria and access to patients.
Finally, review the 'REGULATORY COMPLIANCE/ADMINISTRATIVE PROCEDURES' section for IRB details and attach necessary documents as indicated.
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Review the study protocol and have a thorough understanding of the entire document. Bring clinical trial monitoring tools! Use the Visit To Do List to stay focused and on task. Provide the site staff with a copy of the Action Item List and use the other copy to write the Monitoring Visit Report and Follow-Up Letter.
What is a monitoring visit in clinical research?
Monitoring visits are an essential component of any clinical research project. They help the sponsor and the Clinical Research Associate (CRA) confirm the integrity of the study data as well as ensuring the safety of the study subjects/participants.
What does a CRA monitor do?
The CRA is responsible for monitoring the clinical trial across multiple study sites. They review clinical reporting documentation, ensure compliance with the protocol and sponsor SOPs, and address ethical and regulatory considerations.
What is the purpose of monitoring research?
The purpose of monitoring a study is defined in GCP as ensuring that: 1. The rights and well-being of study human subjects are protected. 2. The reported trial data are accurate, complete and verifiable from source documents.
What is the difference between audit and monitoring in clinical research?
Scope: Monitoring typically focuses on specific areas of the trial, such as data collection and safety reporting, while auditing has a broader scope and can look at all aspects of the trial, including the protocol, the procedures, and the documentation.
Related Searches
if the fda investigator issues a form fda 483 after an inspection, the clinical investigator should:the fda requires retention of investigational drug study records for:which monitoring visit would not include an inventory of investigational agents?
What is the purpose of the monitoring visit report?
The purpose of monitoring is to verify that: The rights and well-being of the human subjects are protected. The reported trial data are accurate, complete and verifiable from source documents.
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