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Data safety and monitoring plan example

Data safety and monitoring plan example 2025

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The document is a sample Data and Safety Monitoring Plan (DSMP) template designed for clinical studies, specifically focusing on the oversight of participant safety and data integrity. It outlines essential components such as study identification, purpose, confidentiality measures, adverse event definitions and reporting, data quality management, subject accrual compliance, informed consent processes, and the role of an Independent Monitor. The DSMP serves as a guideline to ensure that studies adhere to ethical standards and regulatory requirements while protecting participant welfare.

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What is included in a monitoring plan?

The monitoring plan should also include the responsibility for the different indicators and data collection. Describes all the stakeholders who will access the plan and use the collected data. It also includes where and how the data and findings will be stored, such as a report or dashboard.

What is a DSMP relevant for?

A Data and Safety Monitoring Plan (DSMP) is meant to assure that each clinical investigation has a system for appropriate oversight and monitoring of the conduct of the clinical investigation.

What is the full form of DSMP in medical terms?

Designated Supervising Medical Practitioner (DSMP) Information. For the Pharmacist Independent Prescribing course you will need to have a minimum of 90 hours of supervised time with the Designated Supervising Medical Practitioner (DSMP).

What is a DSMP plan?

Data Safety Monitoring Plan (DSMP): A DSMP is a quality assurance plan for a research study. A Data and Safety Monitoring Plan (DSMP) is meant to assure that each clinical investigation has a system for appropriate oversight and monitoring of the conduct of the clinical investigation.

What does a monitoring plan include?

A monitoring plan consists of several key components that ensure accurate monitoring and reporting. These components include compliance with specific programs, reporting frequencies, emission units, emission points, monitoring systems, pollution control devices, and additional monitoring requirements.

What is a data and safety monitoring plan?

A data and safety monitoring plan (DSMP) is a specific plan, developed by the local principal investigator (PI) that outlines how study progress will be monitored throughout the course of the research to ensure the safety of subjects as well as the integrity and confidentiality of data.

What is a DSMP?

A Data and Safety Monitoring Plan (DSMP) is required for all research, regardless of the risk level. Investigators must have adequate plans in place to protect human subjects throughout data collection and analysis. Investigators should maintain a data safety monitoring plan and update policies throughout the research.

How does a DSMB work?

The primary responsibilities of the DSMB are to 1) periodically review and evaluate the accumulated study data for participant safety, study conduct and progress, and, when appropriate, efficacy, and 2) make recommendations to NIDCR concerning the continuation, modification, or termination of the trial.

Data safety and monitoring plan example 2025

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