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Protocol IPI14507
Duelist (IPI145)Vera stem, Inc. STUDY PROTOCOL
IPI14507
Protocol Title:A Phase 3 Study of IPI145 versus Ofatumumab in Patients
with Relapsed or Refractory Chronic Lymphocytes
Leukemia/Small
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How to fill out a phase 3 study
How to fill out a phase 3 study
01
Start by reading the study protocol to understand the objectives, design, and requirements for the phase 3 study.
02
Gather all necessary documents, including informed consent forms, case report forms, and any additional study-specific forms.
03
Ensure that the study site has the necessary equipment, facilities, and trained personnel to conduct the phase 3 study.
04
Recruit eligible participants according to the inclusion and exclusion criteria specified in the study protocol.
05
Obtain informed consent from the participants before enrolling them in the study.
06
Randomize participants into different treatment groups, if applicable.
07
Collect data by conducting study visits, performing tests or assessments, and recording the necessary information in the case report forms.
08
Monitor the study progress by regularly reviewing the collected data and resolving any discrepancies or issues that may arise.
09
Analyze the collected data using appropriate statistical methods and interpret the results.
10
Prepare a comprehensive report summarizing the findings of the phase 3 study, including the efficacy and safety outcomes.
11
Submit the report to the appropriate regulatory authorities for review and approval, if required.
12
Ensure compliance with all ethical and regulatory guidelines throughout the entire process.
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What is a phase 3 study?
Phase 3 study is the third stage of clinical trials where the drug or treatment is tested on a larger group of people to confirm its effectiveness and monitor side effects.
Who is required to file a phase 3 study?
The sponsor of the clinical trial is required to file the phase 3 study.
How to fill out a phase 3 study?
A phase 3 study is filled out with detailed information about the clinical trial protocol, participant data, results, and analysis.
What is the purpose of a phase 3 study?
The purpose of a phase 3 study is to further evaluate the efficacy and safety of the drug or treatment on a larger scale before it can be approved for public use.
What information must be reported on a phase 3 study?
A phase 3 study must report detailed results, analysis, adverse events, and any other relevant data related to the clinical trial.
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