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Cambridge Clinical Trials Unit Box 401Standard Operating Procedure CCTV/SOP029 Data Transfer 1. Scope This Standard Operating Procedure applies to staff of the Cambridge Clinical Trials Unit and trial
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01
Identify the specific data and safety parameters that need to be monitored.
02
Establish a monitoring plan with defined frequency of data collection and safety checks.
03
Designate responsible individuals or teams to oversee data and safety monitoring.
04
Implement effective communication channels for reporting and addressing any issues or concerns.
05
Document all monitoring activities and findings for future reference and analysis.

Who needs data and safety monitoring?

01
Clinical trial researchers conducting human subjects research.
02
Pharmaceutical companies developing new medications.
03
Healthcare providers managing patient safety and treatment outcomes.
04
Regulatory agencies overseeing drug approval and monitoring.
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Data and safety monitoring involves regularly reviewing and evaluating data from ongoing research studies to ensure the safety of participants and the integrity of the study results.
Principal investigators and research teams are typically responsible for filing data and safety monitoring reports.
Data and safety monitoring reports are typically filled out by documenting any adverse events, protocol deviations, and data quality issues that occur during the study.
The purpose of data and safety monitoring is to protect the well-being of study participants, ensure the validity of the study results, and uphold ethical standards in research.
Information that must be reported on data and safety monitoring includes adverse events, protocol deviations, data quality issues, and any actions taken to address these issues.
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