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Product: Denosumab
Protocol Number: 20170534
Date: 02 February 2022Page 1 of 102Title Page
Protocol Title:Multi center, Single arm Open label Extension
Study to Assess Long term Safety and Efficacy
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How to fill out an open-label single-arm extension
How to fill out an open-label single-arm extension
01
Begin by carefully reviewing the protocol for the open-label single-arm extension study.
02
Ensure that all necessary documentation is completed accurately, including informed consent forms.
03
Collect any relevant data or samples as outlined in the protocol.
04
Follow any specific instructions for dosing or administration of the study drug.
05
Monitor and record any adverse events or side effects experienced by participants.
06
Communicate regularly with the study team to provide updates on participant progress.
07
Complete all required forms and reports in a timely manner.
Who needs an open-label single-arm extension?
01
Patients who have completed a prior clinical trial involving the study drug may be eligible for an open-label single-arm extension.
02
Researchers and healthcare professionals conducting the study will also require access to an open-label single-arm extension to gather additional data on the safety and efficacy of the drug.
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What is an open-label single-arm extension?
An open-label single-arm extension is a study where all participants receive the same treatment and the treatment is known to both researchers and participants.
Who is required to file an open-label single-arm extension?
The sponsor or investigator of a clinical trial is required to file an open-label single-arm extension.
How to fill out an open-label single-arm extension?
An open-label single-arm extension should be filled out by providing information on the study protocol, treatment arms, study objectives, and participant eligibility criteria.
What is the purpose of an open-label single-arm extension?
The purpose of an open-label single-arm extension is to assess the long-term safety and efficacy of a treatment after the original study has been completed.
What information must be reported on an open-label single-arm extension?
Information that must be reported on an open-label single-arm extension includes adverse events, treatment adherence, and any changes in the study protocol.
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