Submitting progress reports, safety reports, final report, and financial disclosure reports to the Sponsor and the IRB Assuring IRB review and approval including: Initial and continuing review Submitting the current Investigational Brochure Submitting any amendments/modifications for IRB review and approval Reporting to Sub-investigators and research staff of IRB-approved changes to the clinical trial protocol Collecting up-to-date financial disclosure information for all study site who may be involved in the treatment and/or evaluation of research subjects, providing this information to the Sponsor Reporting serious adverse events, protocol violations/deviations, and unanticipated problems in accordance with institutional requirements to the Sponsor and the IRB Reviewing protocol deviations and other unanticipated problems; to include responding to identified Sub-Investigator or research staff non-compliance. Only making changes in a protocol after notifying the sponsor and obtaining IRB approval, except when necessary to eliminate immediate hazards to human subjects 2. Protecting the rights, safety, and welfare of subjects under the investigator’s care including: Personally conducting or supervising the described investigation Assessing the appropriate execution of tasks delegated to Sub-investigators and research staff Delegated task assessments should provide for assurance that the clinical trial is being conducted according to the clinical trial protocol and applicable regulations; that the rights, safety and welfare of the research subjects are being adequately protected; and that there is adequate and appropriate control of the investigational drug or device. In addition, the delegated task assessments should evaluate compliance with the procedures for the reporting of identified adverse events, protocol deviations, and other unanticipated problems (e.g., medical and ethical issues that may arise during the course of the clinical trial) to the Investigator. Reviewing of assessments focused on the appropriate execution of delegated to Sub-investigators and research staff and responding to identified non-compliance or other deficiencies Providing adequate, documented training to all Sub-investigators and research staff who will participate in the conduct of the clinical trial; to include ensuring that the Sub-investigators and research staff: Are familiar with the purpose of the clinical trial and the location of the current version of the clinical trial protocol Have an adequate understanding of the specific details of the protocol and the attributes of the investigational product as needed to perform their delegated tasks Are of regulatory requirements and acceptable standards for the conduct of clinical trials and the protection of human subjects; to include that no changes from the clinical trial protocol are permitted without prior IRB approval
Submitting progress reports, safety reports, final report, and financial disclosure reports to the Sponsor and the IRB Assuring IRB review and approval including: Initial and continuing review Submitting the current Investigational Brochure Submitting any amendments/modifications for IRB review and approval Reporting to Sub-investigators and research staff of IRB-approved changes to the clinical trial protocol Collecting up-to-date financial disclosure information for all study site who may be involved in the treatment and/or evaluation of research subjects, providing this information to the Sponsor Reporting serious adverse events, protocol violations/deviations, and unanticipated problems in accordance with institutional requirements to the Sponsor and the IRB Reviewing protocol deviations and other unanticipated problems; to include responding to identified Sub-Investigator or research staff non-compliance. Only making changes in a protocol after notifying the sponsor and obtaining IRB approval, except when necessary to eliminate immediate hazards to human subjects 2. Protecting the rights, safety, and welfare of subjects under the investigator’s care including: Personally conducting or supervising the described investigation Assessing the appropriate execution of tasks delegated to Sub-investigators and research staff Delegated task assessments should provide for assurance that the clinical trial is being conducted according to the clinical trial protocol and applicable regulations; that the rights, safety and welfare of the research subjects are being adequately protected; and that there is adequate and appropriate control of the investigational drug or device. In addition, the delegated task assessments should evaluate compliance with the procedures for the reporting of identified adverse events, protocol deviations, and other unanticipated problems (e.g., medical and ethical issues that may arise during the course of the clinical trial) to the Investigator. Reviewing of assessments focused on the appropriate execution of delegated to Sub-investigators and research staff and responding to identified non-compliance or other deficiencies Providing adequate, documented training to all Sub-investigators and research staff who will participate in the conduct of the clinical trial; to include ensuring that the Sub-investigators and research staff: Are familiar with the purpose of the clinical trial and the location of the current version of the clinical trial protocol Have an adequate understanding of the specific details of the protocol and the attributes of the investigational product as needed to perform their delegated tasks Are of regulatory requirements and acceptable standards for the conduct of clinical trials and the protection of human subjects; to include that no changes from the clinical trial protocol are permitted without prior IRB approval
Revised%20IND%20checklist.docx