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PPM IRB Protocol Closure or Suspension Form (revised March 2016) Page 2 of 3 INSTITUTIONAL REVIEW BOARD Protocol Closure or Suspension Form
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The institutional review board protocol is a set of guidelines and procedures designed to protect the rights and welfare of human research subjects.
Researchers conducting studies involving human subjects are required to file an institutional review board protocol.
To fill out an institutional review board protocol, researchers must provide detailed information about the study design, methodology, risks, benefits, and protections for human subjects.
The purpose of the institutional review board protocol is to ensure that research involving human subjects is conducted ethically and in accordance with regulatory requirements.
Information reported on an institutional review board protocol includes study objectives, recruitment methods, informed consent procedures, risk mitigation strategies, and procedures for protecting subject confidentiality.
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2016 IRB PPMH MedWatch SAEs educationally cognitively Accrual neonates IND Deviations fetuses INSTITUTIONAL disadvantaged herein Acknowledgement attest terminally economically expectancy electronically disclosed impaired narrative withdrew enrolled inform

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