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SOURCE DATA VERIFICATION CHECKLIST Study No. Site No. Data Checked Date of Procedure/Visit Patient Enrolment Identification Patient Demographics DOB Sex Weight If applicable Informed Consent Version Date Medical History Inclusion Criteria Name of investigational device Physical Observations BP HR RR Lab Tests Results Efficacy Paramet ers Screening Patient Study No. Patient Initials Pre-procedure Study Time Points Follow-Up/Study End Safety Unscheduled Visit s Study End/Discharge...

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How to fill out source data verification checklist

How to fill out source data verification checklist:

01

Review the checklist to ensure you understand all the requirements and objectives.

02

Gather all the necessary source data that needs to be verified.

03

Start by carefully examining each data field against the corresponding information source to ensure accuracy.

04

Double-check the validity and completeness of the data being verified.

05

Document any discrepancies or errors found during the verification process.

06

Make sure to clearly indicate the reason for any discrepancies and propose appropriate corrective actions.

07

Obtain necessary approvals or signatures as required for each verified data field.

08

Ensure that all the required documentation is properly filled out and attached to the checklist.

09

Review the completed checklist to verify its accuracy and completeness.

10

Submit the filled-out source data verification checklist to the designated authority for further processing.

Who needs source data verification checklist:

01

Individuals or organizations involved in data collection or management.

02

Researchers or analysts who rely on accurate and reliable data for their work.

03

Companies or institutions that have regulations or compliance requirements regarding data accuracy and integrity.

04

Auditors or quality management professionals responsible for verifying the accuracy of data used in various processes.

05

Anyone who wants to maintain data quality standards and ensure the reliability of their information.

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What is source data verification checklist?

A source data verification checklist is a tool used to confirm the accuracy and integrity of data collected during research studies or clinical trials. It ensures that the data reported in the study matches the original source documents.

Who is required to file source data verification checklist?

Researchers, sponsors, and clinical trial monitors are typically required to file a source data verification checklist to ensure compliance with regulatory standards and to maintain data integrity.

How to fill out source data verification checklist?

To fill out a source data verification checklist, start by identifying the data that needs verification, compare it against the source documents, mark discrepancies, and document any findings clearly, alongside appropriate annotations and signatures.

What is the purpose of source data verification checklist?

The purpose of a source data verification checklist is to ensure that all data recorded in a study is accurate and corresponds with original source documents, thereby enhancing the reliability and credibility of the research findings.

What information must be reported on source data verification checklist?

The source data verification checklist must report information including the data elements being verified, source document references, any discrepancies found, resolutions to discrepancies, dates of verification, and the signatures of the individuals conducting the verification.

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