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Committee on Clinical Investigation Children's Hospital Boston APPLICATION FOR SPECIMEN & DATA REPOSITORY & REGISTRY FOR CCI OFFICE USE ONLY This form is to be used to obtain IRB approval to establish
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How to fill out committee on clinical investigation:

01
Begin by gathering all necessary information and documentation related to the clinical investigation. This may include study protocols, informed consent forms, investigator brochures, and any other relevant materials.
02
Familiarize yourself with the requirements and guidelines set forth by your institution or regulatory bodies regarding the committee on clinical investigation. This can include understanding the specific forms and templates that need to be filled out.
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Complete the necessary forms accurately and thoroughly. Provide all required information, ensuring clarity and precision in your responses. Include supporting documents as needed.
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Pay attention to any specific instructions or directions provided within the forms. Make sure to follow them accordingly to avoid any delays or issues during the review process.
05
Review your completed forms and double-check for any errors or omissions. It may be helpful to have a colleague or supervisor review your submission to ensure its completeness and accuracy.
06
Submit the filled-out forms and accompanying documents to the appropriate department or committee responsible for reviewing and approving clinical investigations.
07
Keep a copy of all submitted materials for your records.
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Monitor the status of your submission and follow up with the committee if needed.
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Once approved, adhere to any additional requirements or conditions set forth by the committee during the course of the clinical investigation.

Who needs committee on clinical investigation?

01
Researchers or investigators conducting clinical trials or studies that involve human subjects.
02
Institutions or organizations that oversee and regulate clinical research activities.
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Regulatory bodies or government agencies responsible for ensuring the safety and ethical conduct of clinical investigations.
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Ethical committees or review boards established to review, approve, and monitor the initiation, progress, and termination of clinical investigations.
05
Participants or subjects involved in clinical trials or studies, as they rely on the committee's oversight to protect their rights, safety, and welfare.
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The committee on clinical investigation is a regulatory body responsible for reviewing and approving research studies involving human subjects.
Researchers conducting clinical trials or studies involving human subjects are required to file with the committee on clinical investigation.
Researchers must submit a detailed protocol outlining the study design, risks and benefits, informed consent process, and monitoring plan to the committee on clinical investigation.
The purpose of the committee on clinical investigation is to protect the rights and welfare of human subjects participating in research studies.
Researchers must report details of the study protocol, informed consent process, risk mitigation strategies, and potential conflicts of interest.
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