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Services de Mdecine Nuclear Et de RhumatologieClinical trial studyProtocol Amendment n4; 16 December 2014 Replaces Protocol Amendment 3; 08 April 2014A Phase Ilia study of safety, tolerance, pharmacokinetics,

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How to fill out a phase i-iia study

01

Obtain the necessary regulatory approvals and permissions before starting the study.

02

Develop a clear study protocol outlining the objectives, methodology, and inclusion/exclusion criteria.

03

Recruit eligible participants according to the predefined criteria.

04

Obtain informed consent from the participants before starting any study procedures.

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Collect relevant data and perform necessary assessments as per the study protocol.

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Pharmaceutical companies developing new drugs or therapies.

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What is a phase i-iia study?

A phase I-IIa study is a clinical trial conducted to assess the safety and early effectiveness of a new drug or treatment in a small group of humans.

Who is required to file a phase i-iia study?

The sponsor or the entity responsible for conducting the study is required to file a phase I-IIa study.

How to fill out a phase i-iia study?

To fill out a phase I-IIa study, the sponsor must provide detailed information on the study design, objectives, methods, participants, and safety monitoring procedures.

What is the purpose of a phase i-iia study?

The purpose of a phase I-IIa study is to determine the safety, tolerability, optimal dosage, and early effectiveness of a new drug or treatment.

What information must be reported on a phase i-iia study?

A phase I-IIa study must report details of the study protocol, informed consent process, adverse events, and any preliminary efficacy data.

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