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CASSAVA Version number 1 27th August 2018 IRAS ID 251310NonCTIMP Study Protocol Feasibility and design of a trial to determine the optimal mode of delivery in women presenting in preterm labor or
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01
Start by filling out the title of the study protocol, including the study name and protocol version.
02
Provide a brief background and rationale for the study, explaining why it is necessary and relevant.
03
Clearly define the objectives and aims of the study.
04
Describe the study design, including the type of study, study population, and sample size.
05
Outline the study procedures, including any interventions or treatments to be administered.
06
Include information about the data collection methods and tools to be used.
07
Specify the primary and secondary outcomes of the study, as well as any potential risks or benefits for participants.
08
Describe the data analysis plan and statistical methods to be used.
09
Provide details about the ethical considerations and informed consent process.
10
Include a timeline or schedule for the study, outlining key milestones and deadlines.
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Finally, review and revise the protocol as necessary, ensuring that it is clear, concise, and comprehensive.

Who needs non-ctimp study protocol?

01
Non-CTIMP study protocols are required by researchers or investigators conducting non-interventional clinical studies. These studies involve observational research without the administration of investigational medicinal products. They are typically conducted to evaluate the safety, efficacy, or effectiveness of a medical intervention in real-world clinical settings.
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Non-CTIMP study protocol refers to a research study protocol that does not involve the use of Investigational Medicinal Products (IMPs).
Researchers, sponsors, or institutions conducting a non-CTIMP study are required to file the study protocol.
To fill out a non-CTIMP study protocol, researchers need to provide detailed information about the research objectives, methodology, data collection procedures, and ethical considerations.
The purpose of a non-CTIMP study protocol is to ensure that the research is conducted ethically, efficiently, and in compliance with regulatory requirements.
Information such as the research objectives, methodology, participant recruitment criteria, data collection methods, ethical considerations, and data analysis plan must be reported on a non-CTIMP study protocol.
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