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APPENDIX IR TOG 1102Informed Consent Template for Cancer Treatment Trials (English Language)A Phase I Study of Induction Golimumab and, Followed by Golimumab, and 3DConformal Radiation Therapy (3DCRT)
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How to fill out a phase i study

01
Begin by thoroughly reviewing the protocol and any other relevant documentation related to the phase I study.
02
Familiarize yourself with the inclusion and exclusion criteria for the study participants.
03
Obtain informed consent from eligible participants before enrolling them in the study.
04
Schedule and conduct the necessary screening procedures to ensure participants meet the required criteria.
05
Administer the investigational drug or treatment to the enrolled participants according to the study protocol.
06
Monitor and document any adverse events or reactions experienced by the participants during the study.
07
Conduct regular assessments and follow-up visits as specified in the study protocol.
08
Collect and record all relevant data and observations accurately and in a timely manner.
09
Analyze the collected data and prepare a comprehensive report of the phase I study findings.
10
Submit the report to the appropriate regulatory authorities and stakeholders for review and evaluation.

Who needs a phase i study?

01
Individuals or organizations involved in the development of new drugs or treatments
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Pharmaceutical companies
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Researchers and scientists
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Clinical research organizations (CROs)
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A Phase I study is the first stage of testing in human clinical trials. These trials are conducted to determine the safety and dosage range of a new drug or treatment.
Researchers conducting the clinical trial are required to file a Phase I study.
To fill out a Phase I study, researchers must provide detailed information about the drug or treatment being tested, the study design, and the expected outcomes.
The purpose of a Phase I study is to evaluate the safety and dosage range of a new drug or treatment in humans.
Information such as the study protocol, participant demographics, adverse events, and study results must be reported on a Phase I study.
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