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PLANADDENDUMSUMMARYANDAPPROVAL PROJECTINFORMATION Project:ARPHES9999(479)PCN:Location:FortBertholdReservationDate:2/1/2022LeadDesigner:BidOpeningDate: 2/11/2022JOB#:23351SaraCahlin23351Addendum#:2
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01
Log in to clinicaltrials.gov.
02
Locate the section for creating a new study.
03
Fill in the required fields, including study title, study design, and study description.
04
Select 'randomized placebo-controlled double-blind' as the study design.
05
Provide detailed information on the treatment groups, blinding procedures, and randomization process.
06
Review and edit the information before submitting the study for approval.

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Researchers and scientists conducting clinical trials that require a rigorous study design to minimize bias and ensure the reliability of results.
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Regulatory agencies and ethics committees overseeing clinical trials to ensure the safety and integrity of the research process.
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This type of trial involves randomly assigning participants to either the treatment group or the control group, with neither the participants nor the researchers knowing who is receiving the treatment or the placebo.
Researchers conducting clinical trials are required to file this type of trial on the ClinicalTrials.gov database.
Researchers must provide detailed information about the study design, participants, interventions, outcomes, and other relevant aspects of the trial.
The purpose of this type of trial is to determine the effectiveness and safety of a new treatment compared to a placebo.
Researchers must report information on study design, participant eligibility criteria, interventions, outcomes measures, adverse events, and results.
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