PPT-Tool: Training Presentation: Clinical Research Responsibilities for NIDCR-Funded Investigators

Purpose To provide an overview of the key roles and responsibilities of investigators and staff engaged in NIDCRfunded research AudienceUser NIDCR study staff including PIs SubIs and Site Study Coordinators. Misconduct: . Risks and Best Practices. Allison Moriarty. Vice President, Research Administration and Compliance. Resources. Partners Policies onTrove: . http://library.partners.org/PartProd/webserver/custom/trovedemoframeset.asp?HU=http://www.partners.org&P2=1&w=800&h=600&c=16. Sponsor Responsibilities . Based on ICH . E6. GCP Guidance (Section. 5). Purpose:. To . provide an overview of Sponsor Responsibilities . to study sites. Audience/User:. NIDCR. study staff, including PIs, Sub-Is, and Site . Challenges . of . FDA-Regulated . Research. Pat Ward & Diane Wilson. UMMS Regulatory Affairs. With special thanks to Kara Morgenstern, HSLO. Human Subject Research at UM. All – Governed by University policy. of the . Clinical Research . Team. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. Kathleen.omalley@jefferson.edu. Learning Objectives:. Name the required and possible members of the research team. Based on ICH . E6. GCP Guidance (. Sections1.24. &. 6) . and 45 . CFR. 46: Protection of Human Subjects . Purpose:. To . provide an overview of Investigator Responsibilities and GCP. to study sites. Tool:. Clinical Monitoring Overview Training Slides. Purpose:. To. let study staff know what to expect during a monitoring visit. Audience/User:. NIDCR. study staff, including PIs, Sub-Is, and Site Study Coordinators. Overview of Good Clinical Practices (GCP) . Investigator and Study Team Responsibilities. Miles McFann. IRB Administration. Training and Outreach. 2. Good Clinical Practice is the compilation of accepted ethical and scientific standards governing clinical research that ensure the integrity of data obtained and the protection of human research subjects.. Tool:. Clinical Monitoring Overview Training Slides. Purpose:. To. let study staff know what to expect during a monitoring visit. Audience/User:. NIDCR. study staff, including PIs, Sub-Is, and Site Study Coordinators. Based on ICH . E6. GCP Guidance (. Sections1.24. &. 6) . and 45 . CFR. 46: Protection of Human Subjects . Purpose:. To . provide an overview of Investigator Responsibilities and GCP. to study sites. 1 Resources and Environment The Massachusetts General Hospital (MGH) is consistently ranked as one of the top hospitals in the nation. MGH is known for revolutionizing care and has a long, rich 1 , PHS, and HMS RESOURCES AND ENVIRONMENT The Massachusetts General Hospital has a long, rich, and diverse tradition of excellence in clinical research that continues to expand today. The extensiv Derita: . dbran@uthsc.edu. Margaret: . mlynn@uthsc.edu. https://tnctsi.uthsc.edu/training-and-education/seminars-and-workshops/tn-ctsi-certification-exam-preparation-course/. Handout/. Reference sheets:. TN-CTSI. Derita Bran, BSN, RN, CCRC. Molly Rolen, BSN, RN, CCRP. Research Reflection series co-sponsored by . TN-CTSI and UTHSC Office of Research Development. 1. Disclaimer. This is a general slide presentation and should not be considered all- inclusive of a researcher’s responsibilities. Presented by the . Research Quality Compliance Network.  . PRESENTERS. Ginger Bair, CCRP – QA/QC Coordinator, Office of Quality Compliance and CTSI. Josh Fessel, MD, PhD . –. . Senior Clinical Advisor, Division of Clinical Innovation, NCATS and NIH.