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APPENDIX IR TOG 0239SAMPLE CONSENT FOR RESEARCH STUDYSTUDY TITLE PHASE II Study of ACCELERATED HIGH DOSE OF Thoracic Irradiation with Concurrent Chemotherapy for Patients with Limited Small Cell Lung
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To fill out a phase II study, follow these steps:
02
Define the study objectives and research question.
03
Determine the target population and eligibility criteria for participants.
04
Design the study protocol, including the type of intervention, sample size estimation, and study duration.
05
Obtain ethical approval from the relevant regulatory bodies.
06
Recruit participants who meet the eligibility criteria.
07
Implement the study interventions and collect the necessary data.
08
Analyze the collected data using appropriate statistical methods.
09
Interpret the results and draw conclusions based on the study findings.
10
Prepare a comprehensive report of the study, including the methodology, results, and conclusions.
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Disseminate the findings through publications or presentations.

Who needs a phase ii study?

01
A phase II study is needed by researchers, pharmaceutical companies, and regulatory agencies involved in drug development.
02
It allows them to evaluate the safety and effectiveness of a new intervention or treatment in a controlled setting.
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Phase II studies help determine whether a drug or intervention should proceed to the next phase of clinical trials, where it is tested on a larger scale.
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These studies also provide valuable data for regulatory submissions and inform decision-making regarding further development or discontinuation of the intervention.

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A phase II study is a clinical trial conducted to evaluate the effectiveness and safety of a treatment or intervention in a larger group of patients than in a phase I study.
Researchers, pharmaceutical companies, or other organizations conducting clinical trials are required to file a phase II study.
A phase II study is typically filled out by researchers or sponsors of the clinical trial, following specific guidelines set by regulatory authorities.
The purpose of a phase II study is to gather more information about the safety and effectiveness of a treatment or intervention, and to determine the appropriate dosage or regimen for further testing in phase III trials.
A phase II study must report detailed information on the study design, patient population, treatment protocol, outcomes, adverse events, and statistical analysis.
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