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INVESTIGATOR INITIATED STUDY PROGRAM STUDY CONCEPT PROPOSAL From The purpose of this form is to collect information to evaluate the scientific merit of the proposed study. Submissions will be reviewed
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How to fill out investigator initiated study program

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How to fill out an investigator initiated study program:

01
Obtain the necessary forms: Start by obtaining the required forms for the investigator initiated study program from the appropriate institution or organization. These forms may be available online or can be requested through the relevant research department.
02
Review guidelines and instructions: Carefully read through the guidelines and instructions provided with the forms. These guidelines will outline the specific requirements and procedures for filling out the investigator initiated study program application.
03
Gather relevant information: Collect all the necessary information and data required for the application. This may include details about the study objectives, methodology, participants, data collection procedures, and any potential risks or benefits associated with the study.
04
Complete the application form: Fill out the application form with accurate and complete information. Ensure that all sections of the form are properly filled, including personal details, study title, research aims, funding requirements, and any additional supporting documents that may be requested.
05
Develop a study protocol: Along with the application form, most investigator initiated study programs require the submission of a study protocol. This protocol outlines the study design, procedures, data analysis plan, and ethical considerations. Take the necessary time to develop a comprehensive and well-structured study protocol.
06
Seek necessary approvals: Depending on the institution or organization, you may need to seek approvals from different entities such as the research ethics board, sponsor, or regulatory authorities. Follow the specific instructions provided to obtain the required approvals.
07
Submit the application: Once all the required documents are completed, double-check everything for accuracy and completeness. Submit the investigator initiated study program application along with the supporting documents through the designated submission process indicated in the guidelines.

Who needs an investigator initiated study program?

01
Researchers: Investigators who wish to conduct independent research projects may need an investigator initiated study program. These programs allow researchers to design and implement studies based on their own research questions and objectives.
02
Academics and scientists: Investigators working in academic and scientific institutions often require investigator initiated study programs to pursue their research interests. These programs provide a platform for them to explore and contribute new knowledge in their field of expertise.
03
Healthcare professionals: Healthcare professionals such as doctors, nurses, and medical practitioners may need investigator initiated study programs to investigate specific medical interventions, therapies, or procedures. These programs enable them to enhance patient care and contribute to evidence-based medicine.
04
Pharmaceutical and biotech companies: Investigators working in pharmaceutical and biotech companies may also engage in investigator initiated study programs. These programs allow companies to explore the efficacy, safety, and practical use of their products or innovative technologies.
In summary, filling out an investigator initiated study program involves obtaining the necessary forms, reviewing guidelines and instructions, gathering relevant information, completing the application form, developing a study protocol, seeking necessary approvals, and submitting the application. Various individuals across different disciplines may need investigator initiated study programs to pursue their research and scientific goals.
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An investigator initiated study program is a research study that is proposed, designed, and implemented by an investigator or a team of investigators.
Investigators who are leading the study or the institution where the study is being conducted are required to file the investigator initiated study program.
Investigators can fill out the investigator initiated study program by providing detailed information about the study design, objectives, methods, and ethical considerations.
The purpose of investigator initiated study program is to generate new knowledge, improve patient care, and advance medical science.
Investigators must report information such as study protocol, informed consent forms, recruitment strategies, data collection methods, and potential conflicts of interest.
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