Pdf toolbox trial request4/16/2023 Multi-site Appendix G-4: Vital Signs Form Multi-site Appendix G-3: Prior and Concomitant Medications Form Multi-site Appendix G-2: Medical History Form Multi-site Appendix G-1: Demographics Form Multi-site Appendix G: Sample Case Report Forms and Completion Instructions Multi-site Appendix F: Sample Eligibility Checklist Multi-site Appendix E: Sample Informed Consent Process Checklist Multi-site Appendix D: Sample Protocol Deviation Log Multi-site Appendix C: Sample Unanticipated Problem Form Multi-site Appendix B: Sample Serious Adverse Event Form Multi-site Appendix A: Sample Adverse Event Form The MOP is developed to facilitate consistency in protocol implementation and data collection across study visits, participants and clinical sites. These templates support MOPs that will be developed for multi-site or single-site studies. The NIAMS has guidelines and templates to help investigators develop a study MOP. NIH Protocol Template for Behavioral and Social Science Research (BSSR) Involving Humans NIAMS Templates for Developing a Manual of Operating Procedures (MOP) This template is to help behavioral and social science researchers prepare research protocols for human studies studying a social and behavioral or social science-based intervention. NIH-FDA Protocol Template for Phase 2 and 3 Clinical Trials NIH Protocol Template for Behavioral and Social Science Research (BSSR) Involving Humans This template aims to facilitate the development of Phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) application. For further guidance or questions, reach out to the NIAMS Clinical Research Operations and Management Branch at Protocol Templates for Clinical Trials NIH-FDA Protocol Template for Phase 2 and 3 Clinical Trials NIAMS-funded investigators are encouraged to use the NIH/NIAMS tools and templates when developing their study documents.
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