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Phase 1 Trial of Treatment for Severe Retinopathy of Prematurity Informed Consent Form April 13, 2018 NCT02390531RETINOPATHY OF PREMATURITY 1 (ROP1) Phase 1 Trial of Treatment for Severe Retinopathy
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01
Start by reviewing the study protocol for the phase 1 trial.
02
Familiarize yourself with the inclusion and exclusion criteria to determine if you are eligible to participate.
03
Consult with the study coordinator or principal investigator for any clarifications or questions.
04
Complete the informed consent process, which includes understanding the purpose and risks of the trial.
05
Provide all necessary medical history and personal information as requested.
06
Undergo a physical examination to assess your overall health.
07
Follow the instructions for any required laboratory tests or imaging scans.
08
Attend all scheduled study visits and follow the trial protocol diligently.
09
Report any potential side effects or adverse reactions to the study team.
10
Stay in contact with the study team for the duration of the trial and communicate any challenges or concerns that may arise.

Who needs phase 1 trial of?

01
Phase 1 trials are typically conducted on healthy volunteers or individuals who meet specific criteria.
02
These trials are essential for testing the safety, dosage, and potential side effects of a new drug or treatment.
03
Researchers, pharmaceutical companies, and regulatory bodies rely on phase 1 trials to gather initial data on the drug's efficacy and potential risks.
04
Individuals who have a particular medical condition or disease that the new treatment aims to address may also participate in phase 1 trials.
05
Ultimately, anyone who is willing to contribute to medical research and meet the eligibility criteria can participate in a phase 1 trial.
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Phase 1 trial is primarily designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug or treatment in a small group of healthy participants.
Pharmaceutical companies and researchers conducting clinical trials are required to file for phase 1 trials with regulatory authorities.
Filling out a phase 1 trial submission involves compiling detailed information about the trial protocol, including study objectives, design, participant eligibility criteria, dosing information, and safety monitoring plans.
The purpose of phase 1 trial is to evaluate the safety of a new drug or treatment, determine a safe dosage range, and identify potential side effects.
Information that must be reported includes study design, participant demographics, safety results, adverse events, and pharmacokinetic and pharmacodynamic data.
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