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Protocol PUL01 Protocol Version 3.0, dated 17 June 2020Rockefeller University Institutional Review Board IRB NUMBER: OBE1012 IRB APPROVAL DATE: 06/20/2020 Pulmoquine Therapeutics, Inc. IRB EXPIRATION

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How to fill out protocol deviation tracking log

01

To fill out a protocol deviation tracking log, follow these steps:

02

Start by identifying the protocol deviation that occurred.

03

Fill out the date and time of when the deviation was detected.

04

Provide a brief description of the deviation, including relevant details.

05

Document the potential impact of the deviation on the study or research.

06

Determine the root cause of the deviation, if possible.

07

Assess the severity of the deviation and categorize it accordingly.

08

Identify any corrective actions that should be taken to address the deviation.

09

Specify the individuals responsible for implementing the corrective actions.

10

Assign a target date for completing the corrective actions.

11

Document any follow-up actions or additional steps that need to be taken.

12

Obtain necessary approvals and signatures on the tracking log as required.

13

Store the completed protocol deviation tracking log for future reference and audit purposes.

Who needs protocol deviation tracking log?

01

Protocol deviation tracking logs are needed by researchers, scientists, and organizations conducting studies or research that adhere to specific protocols.

02

These logs help ensure compliance with protocols and allows for proper documentation and tracking of any deviations that may occur during the study or research process.

03

Regulatory bodies, ethics committees, and sponsors may also require the submission of protocol deviation tracking logs for monitoring and review purposes.

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What is protocol deviation tracking log?

The protocol deviation tracking log is a document used to record and monitor any deviations from the study protocol during a clinical trial.

Who is required to file protocol deviation tracking log?

The designated study personnel, such as the Principal Investigator or study coordinator, are responsible for filing the protocol deviation tracking log.

How to fill out protocol deviation tracking log?

The protocol deviation tracking log should be filled out accurately and concisely, providing details such as the nature of the deviation, date of occurrence, impact on subject safety, and any corrective actions taken.

What is the purpose of protocol deviation tracking log?

The purpose of the protocol deviation tracking log is to document any deviations from the study protocol, assess their impact on the study, and ensure compliance with regulatory requirements.

What information must be reported on protocol deviation tracking log?

Information such as the nature of the deviation, date of occurrence, impact on subject safety, corrective actions taken, and any follow-up measures must be reported on the protocol deviation tracking log.

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