Maintenance of research records as required for the trial (e.g., locked cabinet) Source documents are readily available for review Adequate equipment is available for study, and equipment maintenance is verified (e.g., internet access to a computer for randomizing subjects in WebDCU™) Staffing and Training The Site Monitor will insure that the Monitoring Visit include, but not be limited to, confirmation of the following: Activities being carried out by qualified staff appropriately listed on log Study staffing remains unchanged and/or study personnel/new personnel are adequate; documentation of staff qualifications is available (i.e., updated Delegation of Authority log, listed on the project spoke team member table in and WebDCU™, an IRB approval letter for adding new team members) Investigator and/or Sub-Investigator is/are actively participating in the study Informed Consent (IC) Process The Site Monitor will have the goal to conduct a 100% review of signed and dated informed consent (IC) forms, and report any deviations (e.g., verify correct version of IC signed and dated for all participants). Subject files will also be monitored to ensure the site is appropriately documenting the consent process. The informed consent process should be documented within the research records, noting the following: Date and time consent obtained Consent signed by subject (no surrogate allowed in the study) Statement to confirm the subject received a copy of the signed consent Assessment of the to understand the information provided subject’s ability Statement to confirm review of consent with subject (e.g., risks/benefits, voluntary participation, confidentiality, compensation, questions answered) Statement to confirm subject meets eligibility criteria Verification of Eligibility The Site Monitor will verify that Inclusion/Exclusion criteria are met for enrolled participants. Protocol Review and Compliance The Site Monitor will ensure that:
Maintenance of research records as required for the trial (e.g., locked cabinet) Source documents are readily available for review Adequate equipment is available for study, and equipment maintenance is verified (e.g., internet access to a computer for randomizing subjects in WebDCU™) Staffing and Training The Site Monitor will insure that the Monitoring Visit include, but not be limited to, confirmation of the following: Activities being carried out by qualified staff appropriately listed on log Study staffing remains unchanged and/or study personnel/new personnel are adequate; documentation of staff qualifications is available (i.e., updated Delegation of Authority log, listed on the project spoke team member table in WebDCU™, and an IRB approval letter for adding new team members) Investigator and/or Sub-Investigator is/are actively participating in the study Informed Consent (IC) Process The Site Monitor will have the goal to conduct a 100% review of signed and dated informed consent (IC) forms, and report any deviations (e.g., verify correct version of IC signed and dated for all participants). Subject files will also be monitored to ensure the site is appropriately documenting the consent process. The informed consent process should be documented within the research records, noting the following: Date and time consent obtained Consent signed by subject (no surrogate allowed in the study) Statement to confirm the subject received a copy of the signed consent Assessment of the subject’s ability to understand the information provided Statement to confirm review of consent with subject (e.g., risks/benefits, voluntary participation, confidentiality, compensation, questions answered) Statement to confirm subject meets eligibility criteria Verification of Eligibility The Site Monitor will verify that Inclusion/Exclusion criteria are met for enrolled participants. Protocol Review and Compliance The Site Monitor will ensure that:
point_monitoring_plan_v2.0_tracked_final_11may2017.docx