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Secondary Protocol Deviations Log Holland Bloodied Kids Rehabilitation Hospital Study Title: Principal Investigator: RED #: No. Date of Event (mm/dd/by)Date Event Discovered (mm/dd/by)Participant

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How to fill out reb-406 protocol deviation this

01

Review the protocol deviation form - reb-406

02

Fill in the required fields including study information, date and time of deviation, description of deviation, impact of deviation on study, corrective actions taken, and signatures of relevant personnel

03

Submit the completed form to the appropriate parties for review and approval

Who needs reb-406 protocol deviation this?

01

Researchers conducting studies that have encountered protocol deviations

02

Regulatory authorities overseeing the study

03

Institutional review boards (IRBs) or ethics committees

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What is reb-406 protocol deviation this?

Reb-406 protocol deviation refers to any deviation from the regulatory requirements outlined in REB-406 protocol for research activities.

Who is required to file reb-406 protocol deviation this?

The Principal Investigator or the research team is required to file reb-406 protocol deviation.

How to fill out reb-406 protocol deviation this?

To fill out reb-406 protocol deviation, the PI or research team must document the deviation, provide justification, and submit it to the appropriate regulatory body.

What is the purpose of reb-406 protocol deviation this?

The purpose of reb-406 protocol deviation is to document any deviations from the approved research protocol and ensure transparency in research activities.

What information must be reported on reb-406 protocol deviation this?

The information reported on reb-406 protocol deviation must include details of the deviation, reasons for the deviation, impact on research outcomes, and any corrective actions taken.

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