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MODELINFORMEDCONSENTDOCUMENT VersionDate:5January2015 TitleofStudy: EstablishedStatusEpilepticusTreatmentTrial(SETT): Multimeter, randomized, blinded, comparativeeffectivenessstudyoffosphenytoin,
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Start by clearly stating the title of the document as 'Model Informed Consent Document'.
02
Include a brief introduction explaining the purpose and importance of the document.
03
Include a section that states the background and objectives of the study or project for which consent is being obtained.
04
List all the procedures, assessments, or interventions that the participant will undergo in a step-by-step manner.
05
Clearly explain the potential risks and benefits associated with participating in the study.
06
Include a section that explains the voluntary nature of participation and the participant's right to withdraw at any time without consequences.
07
Provide a detailed description of the confidentiality measures that will be taken to protect the participant's privacy and how the data will be used.
08
Include a section that outlines the participant's rights and responsibilities.
09
Provide contact information for the principal investigator or research team in case the participant has any questions or concerns.
10
Create space for the participant or their representative to sign and date the document to indicate their informed consent.

Who needs model informed consent document?

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Model informed consent documents are needed by researchers, medical professionals, or individuals conducting studies or projects that involve human participants.
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These documents are essential to ensure that participants are fully informed about the purpose of the study, the procedures involved, and the potential risks and benefits before they provide their consent to participate.
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The model informed consent document is a standardized form that outlines the information a participant needs to know before deciding whether or not to participate in a research study.
Researchers and institutions conducting research studies involving human participants are required to file model informed consent documents.
The model informed consent document should be filled out by including all relevant information about the study, risks and benefits, participant rights, and any other necessary details.
The purpose of the model informed consent document is to ensure that participants are fully informed about the research study they are being asked to participate in, and to ensure that their rights and safety are protected.
The model informed consent document must include information about the study procedures, risks and benefits, confidentiality of data, voluntary participation, and contact information for questions.
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