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Clinical InvestigatorInitiated Study (IIS)
Research Support ApplicationCLINICAL IIS RESEARCH SUPPORT APPLICATION
* Required Information1. CONTACT GENERAL INFORMATION*
A. PRIMARY JANSSEN PHARMACEUTICAL
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How to fill out clinical investigator-initiated study iis
How to fill out clinical investigator-initiated study iis
01
Step 1: Review the requirements and guidelines provided by the research institution or funding agency for filling out the clinical investigator-initiated study (IIS) application.
02
Step 2: Gather all necessary information and documentation, including study objectives, study design, protocol, informed consent forms, recruitment strategies, data collection methods, and statistical analysis plan.
03
Step 3: Fill out the application form accurately and thoroughly, providing all requested information.
Who needs clinical investigator-initiated study iis?
01
Clinical investigators who have a research question or hypothesis and wish to conduct a study that is initiated and led by themselves.
02
Institutions or organizations that require studies to be conducted to evaluate the safety, efficacy, or effectiveness of a particular intervention or treatment.
03
Funding agencies that provide grants or resources for investigator-initiated studies.
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What is clinical investigator-initiated study iis?
Clinical investigator-initiated study (IIS) is a clinical study conducted by an investigator or group of investigators, independent of a sponsor, that is designed to explore a specific research question.
Who is required to file clinical investigator-initiated study iis?
The clinical investigator or group of investigators who are conducting the study are required to file the clinical investigator-initiated study (IIS).
How to fill out clinical investigator-initiated study iis?
To fill out clinical investigator-initiated study (IIS), the investigators need to provide detailed information about the study protocol, objectives, methods, and potential risks and benefits.
What is the purpose of clinical investigator-initiated study iis?
The purpose of clinical investigator-initiated study (IIS) is to generate scientific data on a specific research question without the influence of a sponsor, to advance medical knowledge and improve patient care.
What information must be reported on clinical investigator-initiated study iis?
The clinical investigator-initiated study (IIS) must report information on the study protocol, participant enrollment, adverse events, data analysis, and conclusions.
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