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EMPOWER Protocol Deviation Report Please answer all questions. Submit typed form with signatures to the EMPOWER Coordinating Center. Site Name: EMPOWER Site Code: Site Investigator: Form completed
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How to fill out empower protocol deviation report

01
To fill out the empower protocol deviation report, start by gathering all relevant information regarding the deviation. This includes the date and time of the deviation, the individuals involved, and any documentation or evidence related to the incident.
02
Begin by filling out the basic details section of the report. This typically includes fields such as the study or project name, protocol number, and the name and contact information of the person responsible for reporting the deviation.
03
Provide a clear and concise description of the protocol deviation in the designated section of the report. Include as much detail as possible, such as what specific step or procedure was deviated from, how it deviated, and any potential impact or consequences as a result.
04
If applicable, provide any additional information or context that may be relevant to understanding the deviation. This can include any mitigating factors, previous instances of similar deviations, or any corrective actions that were taken.
05
Complete any sections or fields related to the follow-up actions taken. This may include steps taken to address the deviation, any remedial actions implemented, or any changes made to the study or project protocol as a result.
06
Review the completed empower protocol deviation report for accuracy and completeness. Make sure that all required fields are filled out and that the information provided is clear and concise.
07
Save a copy of the completed report for your records and submit it to the appropriate individuals or departments, as outlined by your organization's protocols.
Who needs an empower protocol deviation report:
01
Researchers or study coordinators involved in clinical trials or research projects that require adherence to specific protocols.
02
Compliance officers or regulatory bodies responsible for ensuring adherence to protocols and monitoring deviations.
03
Sponsors or funding agencies that require documentation and reporting of protocol deviations to ensure the integrity and validity of the study or project.
It is important to note that the specific individuals or departments who need an empower protocol deviation report may vary depending on the organization and the nature of the study or project.
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What is empower protocol deviation report?
Empower protocol deviation report is a document that outlines any deviations from the established protocol during a study or research project.
Who is required to file empower protocol deviation report?
The individuals responsible for conducting the study or research project are required to file empower protocol deviation report.
How to fill out empower protocol deviation report?
Empower protocol deviation report can be filled out by documenting the details of the deviation, including the date, nature of the deviation, impact on the study, and corrective actions taken.
What is the purpose of empower protocol deviation report?
The purpose of empower protocol deviation report is to ensure transparency and accountability in research studies by documenting any deviations from the established protocol.
What information must be reported on empower protocol deviation report?
The empower protocol deviation report must include details such as the date of the deviation, nature of the deviation, impact on the study, and any corrective actions taken.
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