and unexpected adverse events) Results of Principal Investigator (PI) Each Study Visit Prior to Submitting IRB Continuing Review diagnostics tests Research Team member Other: specify Any time an unanticipated problem is and images Independent Safety Monitor suspected Other: specify Other: e.g., monthly, 6 months, etc. Principal Investigator (PI) Each Study Visit Prior to Submitting IRB Continuing Review Research Team member Other: specify Any time an unanticipated problem is All withdrawals Independent Safety Monitor suspected Other: specify Other: e.g., monthly, 6 months, etc. Principal Investigator (PI) Each Study Visit Prior to Submitting IRB Continuing Review Physical safety Research Team member Other: specify Any time an unanticipated problem is assessments Independent Safety Monitor suspected Other: specify Other: e.g., monthly, 6 months, etc. Principal Investigator (PI) Each Study Visit Prior to Submitting IRB Continuing Review Unanticipated Research Team member Other: specify Any time an unanticipated problem is Problems Independent Safety Monitor suspected Other: specify Other: e.g., monthly, 6 months, etc. Other: specify other Principal Investigator (PI) Each Study Visit Prior to Submitting IRB Continuing Review safety data Research Team member Other: specify Any time an unanticipated problem is Independent Safety Monitor suspected (Insert rows as Other: specify Other: e.g., monthly, 6 months, etc. needed) Monitoring Safety Locally Use this space to briefly describe the local plan to monitor data and continually assess safety of participants in the study. Use Items 1 and 2 above to assist in developing your plan. Section II – Monitoring Data Integrity Routine monitoring of data integrity is critical in clinical trials. Oftentimes, the Sponsor provides a monitor to provide ongoing reviews of the data and ongoing progress of the study. In the absence of a Sponsor, you should have a plan to provide routing monitoring of the study. Monitoring Data Integrity locally Provide a narrative to describe the specific data elements to be reviewed to ensure integrity of the data. For example, you may review inclusion/exclusion criteria, accuracy of data transcription, appropriate recording of units of measure, accuracy of dosage calculations, etc.). Include time points, data points and who is responsible for confirming the data is correct.
and unexpected adverse events) Results of diagnostics tests and images Principal Investigator (PI) Research Team member Independent Safety Monitor Other: specify Each Study Visit Other: specify Prior to Submitting IRB Continuing Review Any time an unanticipated problem is suspected Other: e.g., monthly, 6 months, etc. All withdrawals Principal Investigator (PI) Research Team member Independent Safety Monitor Other: specify Each Study Visit Other: specify Prior to Submitting IRB Continuing Review Any time an unanticipated problem is suspected Other: e.g., monthly, 6 months, etc. Physical safety assessments Principal Investigator (PI) Research Team member Independent Safety Monitor Other: specify Each Study Visit Other: specify Prior to Submitting IRB Continuing Review Any time an unanticipated problem is suspected Other: e.g., monthly, 6 months, etc. Unanticipated Problems Principal Investigator (PI) Research Team member Independent Safety Monitor Other: specify Each Study Visit Other: specify Prior to Submitting IRB Continuing Review Any time an unanticipated problem is suspected Other: e.g., monthly, 6 months, etc. Other: specify other safety data (Insert rows as needed) Principal Investigator (PI) Research Team member Independent Safety Monitor Other: specify Each Study Visit Other: specify Prior to Submitting IRB Continuing Review Any time an unanticipated problem is suspected Other: e.g., monthly, 6 months, etc. Monitoring Safety Locally Use this space to briefly describe the local plan to monitor data and continually assess safety of participants in the study. Use Items 1 and 2 above to assist in developing your plan. Section II – Monitoring Data Integrity Routine monitoring of data integrity is critical in clinical trials. Oftentimes, the Sponsor provides a monitor to provide ongoing reviews of the data and ongoing progress of the study. In the absence of a Sponsor, you should have a plan to provide routing monitoring of the study. Monitoring Data Integrity locally Provide a narrative to describe the specific data elements to be reviewed to ensure integrity of the data. For example, you may review inclusion/exclusion criteria, accuracy of data transcription, appropriate recording of units of measure, accuracy of dosage calculations, etc.). Include time points, data points and who is responsible for confirming the data is correct.