Which of the following could form part of the procedures for a non-interventional imposed PASS?

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The procedures for a non-interventional imposed Post-Authorization Safety Study (PASS) can indeed include elements like patient consent forms, agreements with independent review boards, and summaries of results from previous studies. Each of these components plays a vital role in ensuring that the study is conducted ethically, complies with regulatory requirements, and is informed by existing knowledge.

Patient consent forms are crucial in non-interventional studies as they ensure that participants are fully informed about the study's purpose, potential risks, and their right to withdraw. This is particularly important in maintaining ethical standards and protecting patient rights.

An independent review board (IRB) agreement is necessary to oversee the study's ethical considerations. The IRB reviews the study design, ensures the protection of participants, and confirms that the study complies with applicable regulations and ethical guidelines. This oversight is vital for maintaining public trust and adherence to regulatory standards.

A summary of results from previous studies serves to inform the current study's design and help identify potential risks and benefits associated with the drug in question. This historical context can influence the development of the protocol for the current study, ensuring that it builds on the existing evidence.

Incorporating all these elements reflects a comprehensive approach to conducting a non-interventional imposed PASS, ensuring that ethical considerations

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