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Click ‘Get Form’ to open the Data and Safety Monitoring Plan (DSMP) in the editor.
Begin with Section I: Study Identification Information. Fill in the NIH Study Number, Study Title, and Principal Investigator's name as indicated.
Move to Section II: Study Overview. Provide a brief description of the study's purpose and include an adherence statement that aligns with your protocol.
In Section III: Confidentiality, outline your plan for protecting subject privacy, database security, and confidentiality during adverse event reporting.
Proceed to Section IV: Adverse Event Information. Define adverse events, classify their severity, and outline expected risks associated with participation.
Complete Sections V through VII by detailing data quality management plans, informed consent processes, and any changes in study status as necessary.
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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.
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NIH Data Safety Monitoring Plan exampleData and Safety Monitoring Plan NIHNIH DSMP template
People also ask
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.
Related links
Data Safety Monitoring Plan Template (DOCX)
The WVU Data and Safety Monitoring Plan (DSMP) outlines our commitment to human subject protections at this institution. It is the framework for ensuring that
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