Investigator Training Clinical trials at Avera

Transcript:Investigator Training Clinical trials at Avera:
Investigator Training Clinical trials at Avera Research Institute Overview for Investigator Responsibilities 1. Ensure all aspects of a clinical trial are completed per the Investigative Plan 2. Protecting the rights, safety and welfare of Subjects 3. Control of investigational agent under investigation Supervision of Study Conduct 1. Per Code of Federal Regulation the investigator commits to conduct and supervise the investigative trial 2. The investigator is responsible to assess the study related employees delegated to perform key task and adequately supervise their conduct Appropriate Delegation 1. Investigator Needs to complete and show documentation of completion for all trial related medical decision. Review of screening, medical history and assessment of inclusion/exclusion criteria- this is best documented in a clinical note Physical Exams- unless state law allows APP Evaluation and attribution of Adverse events Assessment of endpoints Oversight of informed consent process Oversight and approval of delegation log Study Timeline Before the study Attend and complete necessary trainings (Site Initiation Visit, EDC system, etc.) Attend a study walkthrough with study staff Sign the delegation log During the study Confirm eligibility of participants after baseline visit Review labs if needed Review Adverse Events/Serious Adverse Events if applicable Attend Monitoring Visits Typically call in for ~15 minutes. Monitoring visits occur every few weeks during the course of the study. Attend PI meeting with study lead 15 minutes weekly After the study Sign off that all components were completed for the study after study close out PI Responsibilities: Additional Resources GCP: file:///C:/Users/scerkovnik/Downloads/Roles%20&%3B%20Responsibilities.pdf FDA: https://www.fda.gov/media/87513/download Introduction to Clinical Research: http://compliance.emory.edu/documents/S-I_Responsibilities.pdf https://www.jefferson.edu/content/dam/university/research/jcri/crf_03_17_pdf/0840_Roles%26Responsibilities.pdf National Cancer Institute: http://cancerpreventionnetwork.org/Roster_Forms/ResponsibilitiesOfResearchTeam_May2020.pdf Data Sponsor ONLY receives deidentified data No name, EMR number, or any other PHI should be sent to the sponsor. If an AE/SAEs or death has occurred, the sponsor may request additional information. Please do not send any materials directly to the sponsor. Report deidentified information in the EDC system. Sponsor may see identifiable data (IF outlined in contract or other appropriate document) on monitoring visits but NEVER send any identifiable data to the sponsor (email, documents, etc.) If there are any questions about sharing data, please ask regulatory specialist. Documentation - EMR Why do we document in the EMR? The patient’s EMR is considered a source document. This means research staff will use the EMR to transpose data directly into the EDC. Research needs documentation on a source document to prove it happened. Example: informed consent, lab draws, physicals, etc.