![]() Electronic Regulatory Binder Templates and Table of Contents: Example for Multi-Center StudiesĪccess Electronic Regulatory Binder template.Īccess Table of Contents template. Electronic Regulatory Binder Templates and Table of Contents:Īccess Electronic Regulatory Binder folders template.Īccess Table of Contents template. This template assists the principal investigator and study team in fulfilling their responsibilities regarding study close-out when all study activities are terminated.Īccess this template. This template is one way to document the initial consenting process, along with the informed consent document.Īccess this template. Documentation of the Informed Consent Process for Research Participation ![]() This template allows the principal investigator and study team to fulfill their responsibilities regarding device accountability record maintenance for significant risk devices.Īccess this template. This template records all assigned study-related responsibilities.Īccess this template. Use it to create a record of contact information for research team members and other parties that are involved in the study.Īccess this template. This template ensures that necessary staff and others can be contacted when needed. Click “Extract All” in the top-left corner and all files will download. Please note: this link will take you to a “All Study Management Templates” zip file. TemplatesĬlick here to download all templates. Guidance documents are also provided to assist you with study management. Please customize the templates to match your study-specific requirements. They may be useful, but not required, to organize study documentation for other studies as well. These templates are designed to help meet requirements for FDA-regulated clinical trials. ![]() The study management templates are a University of Michigan resource available to all study team members. The templates can also help you adhere to high standards of practice in the conduct of studies involving human participants. The study management templates are adaptable and downloadable templates that can be used to organize and maintain research study documentation as you would include in a regulatory binder. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |