Question

In: Operations Management

Managing and Monitoring of Clinical Trials 1. Explain the satellite site expectations when participating in a...

Managing and Monitoring of Clinical Trials

1. Explain the satellite site expectations when participating in a clinical trial.

2. Discuss the expectation for satellite sites and activities around monitoring the satellite sites. You will be graded on 5 facts and your elaboration of those facts.

(In this scenario - assume you are the assigned monitor. Three satellite sites all located Raleigh. Discuss what you would look for to support this type of set up.)

Expert Solution

Ans1- Satellite Site is basically a remote study site for a medical treatment that connected to the main parenting site. To increase the accessibility of people of rural and remote sites. Principal Investigator is the same for the Parent and for satellite site. During the Trial PI can visit ether main site or the satellite site.

satellite site expectations when participating in a clinical trial.

- Provide the medical support in satellite site (rural, remote site)

- Conduct the medical trial in satellite site.

- Monitor the patient for the medical trial.

- Record the data of trial.

- Provide the feedback to main site or principal investigator.

- Maintain the record of clinical trial.

Ans 2- Expectation for the Satellite site and activity around the monitoring the satellite sites-

Expectations for the satellite site –

- Provide the medical support in satellite site (rural, remote site)

- Conduct the medical trial in satellite site.

- Monitor the patient for the medical trial.

- Record the data of trial.

- Provide the feedback to main site or principal investigator.

- Maintain the record of clinical trial

Monitoring the Satellite Site-

- Monitoring the document

- Supervision plan- Make the schedule plan for supervision.

- Site Visits- to understand the real problem of site.

- Verify the role and responsibility of satellite site members.

- Review the status of monitoring devices.

- Review the training status of satellite staff.

Support / Requirement for set up of satellite site –

- Selection of the satellite location and suitable trial.

- Workforce: then roles and responsibility.

- Roles and responsibility of trial staff.

- Training of the satellite staff.

- Technological support for satellite site.

- Medication handling at the satellite site.

- Financial support to develop the site.

keosha answered 2 months ago

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