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NH MRC Clinical Trials Center Clinical Trial Concept Development Workshop for Investigators Friday 18th November 2011 This one day workshop will help clinical investigators refine their concept for
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How to fill out clinical trial concept development

How to fill out clinical trial concept development
01
Start by identifying the objectives and goals of the clinical trial concept development.
02
Design the research questions and hypotheses that the trial will address.
03
Conduct a thorough literature review to gather background information on the topic.
04
Determine the target population and inclusion/exclusion criteria for participant selection.
05
Develop a detailed protocol outlining the study procedure, intervention, and data collection methods.
06
Create the necessary study documentation, such as informed consent forms and case report forms.
07
Submit the concept to the relevant regulatory authorities for approval.
08
Recruit participants for the trial using appropriate recruitment strategies.
09
Implement the study protocol, ensuring adherence to ethical guidelines and regulatory requirements.
10
Collect and analyze the data obtained from the trial.
11
Interpret the results and draw conclusions based on the findings.
12
Prepare the final clinical trial concept development report, including the study outcomes and recommendations for future research.
Who needs clinical trial concept development?
01
Pharmaceutical companies and drug manufacturers
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Academic research institutions
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Government health agencies
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Healthcare organizations and hospitals
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Medical device manufacturers
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Biotechnology companies
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Clinical research organizations (CROs)
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Healthcare providers and clinicians
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Researchers and scientists in the medical field
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