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ALTE05N1 Activated: Closed: May 19, 2008, Version Date: 02/02/10 Amendment: # 2 CHILDREN'S ONCOLOGY GROUP ALTE05N1 Umbrella Long-Term Follow-Up Protocol A Group wide Non-Therapeutic Study THIS PROTOCOL
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The umbrella long-term follow-up protocol is a set of guidelines and procedures that ensure continuous monitoring and evaluation of a study or clinical trial over an extended period of time.
The organization or individuals conducting the study or clinical trial are required to file the umbrella long-term follow-up protocol.
The umbrella long-term follow-up protocol can be filled out by providing the required information, such as study details, patient demographics, follow-up procedures, and data collection methods, in the specified format or template provided by the regulatory authority.
The purpose of the umbrella long-term follow-up protocol is to ensure that the study or clinical trial is conducted ethically and responsibly, as well as to monitor the long-term outcomes and safety of the participants.
The umbrella long-term follow-up protocol typically requires reporting of study objectives, inclusion and exclusion criteria, treatment interventions, follow-up duration, data collection instruments, adverse events reporting, and data analysis plan.
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