Get Bimo Audit Checklist

The Bimo Audit Checklist is an essential tool for ensuring compliance in clinical trials involving human drugs, biologics, and devices. This guide provides step-by-step instructions on how to effectively fill out this checklist online, enabling users to manage their documentation accurately and efficiently.

Follow the steps to complete the Bimo Audit Checklist online.

1. Press the ‘Get Form’ button to access the Bimo Audit Checklist and open it for editing.
2. Begin with the authority and administration section. Compare the Investigator Agreement with information from the assigning center. Gather and document all relevant studies performed by the investigator, including protocol numbers and titles, sponsor names, and study dates.
3. Fill in the Essential Information Report (EIR) with addresses where study subjects were seen, details on how the sponsor communicated information to the investigator, and ensure that authority for the study tasks was properly delegated. Enter the significant dates associated with the study's progress as requested.
4. Document the qualifications of those performing any delegated tasks, and include a list of facilities involved in laboratory or diagnostic testing. Verify compliance with required regulations.
5. Outline the process used for subject recruitment. Document all recruitment materials and ensure they were approved by the Institutional Review Board (IRB). Note any instances of potential coercion in the recruitment process.
6. For the protocol review section, compare the protocol version provided to the investigator's copy. Ensure that the investigator adhered to the protocol, including subject selection, enrollment, and investigational procedures.
7. Collect and review documents supporting the IRB's approval of the study, and ensure compliance with requirements regarding informed consent from study subjects.
8. Review human subjects' records, including the informed consent process and source documents. Confirm compliance with required documentation practices ensuring that all data is accurate and complete.
9. For financial disclosure, inquire about the investigator's financial interests and ensure these were disclosed appropriately to the sponsor as per applicable regulations.
10. After completing all sections, review the filled-out checklist for accuracy. Save your changes, and download, print, or share the completed form as necessary.

Take the time to ensure all sections of the Bimo Audit Checklist are filled out accurately and comprehensively by completing your audit online.