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APPENDIX BARTON 0246SAMPLE CONSENT FOR RESEARCH STUDYSTUDY TITLE A PHASE II STUDY OF A PACLITAXELBASED CHEMORADIOTHERAPY REGIMEN WITH SELECTIVE SURGICAL SALVAGE FOR RESPECTABLE LOCOREGIONALLY ADVANCED
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A phase II study is a clinical trial that evaluates the efficacy and safety of a drug or treatment in a larger group of patients than in a phase I study.
Pharmaceutical companies or researchers conducting clinical trials are required to file a phase II study.
To fill out a phase II study, researchers must follow the protocol approved by the regulatory authorities, collect data on the participants, and analyze the results.
The purpose of a phase II study is to further evaluate the safety and efficacy of a drug or treatment identified in a phase I trial.
Information such as study objectives, methodology, participant demographics, results, adverse events, and conclusions must be reported on a phase II study.
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