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What does a monitoring plan include?

A data monitoring plan must have provisions to monitor individual data points collected for data analysis, as well as required study documentation, such as IRB and sponsor documentation, consent documents, adverse event reports, etc.

What should be included in a data safety monitoring plan?

The initial DSM plan should include a brief description of data management methods, collection and reporting of Adverse Events (AE) and Serious Adverse Events (SAE), medical safety measures, communication plan with IRB/FDA/NIDA, interim analysis plans, and content and frequency of DSM reports to NIDA.

How can a plan be monitored?

Here is a list of steps to take in order to implement an effective project monitoring strategy: Create a plan or outline. Set goals and expectations. Decide how to monitor project. Evaluate reports. Make necessary improvements. Collect and track data. Provide progress updates. Manage expectations.

How do you write a monitoring plan?

How to Develop a Monitoring and Evaluation Plan Identify your evaluation audience. Define the evaluation questions. Identify the monitoring questions. Identify the indicators and data sources. Identify who is responsible for data collection and timelines. Identify who will evaluate the data, how it will be reported, and when.

What does medical monitoring include?

The concept of monitoring overlaps with those of screening and diagnosis. One may monitor a physiologic or pathologic process, a therapeutic or noxious agent, comparing results with the patients previous results or with a group reference range.

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