CHECKLIST: Investigator Self-Assessment

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HRP-430 1/5/2017 1 of 4

INSTRUCTIONS: Please complete the Clinical Research Addendum of the Investigator Self- Assessment only if your study involves clinical research (including IND or IDE studies). Answer all questions as they pertain to study documentation maintained in your regulatory files and provide confirmation of your study conduct. If you have questions while filling out the Investigator Self-Assessment, or would like the Quality Improvement Program (QIP) team to complete the assessment for you, please contact us (http://www.hsph.harvard.edu/ohra/contactslocation/staff-contacts). C. Clinical Research Addendum Protocol # Person(s) Completing Checklist Date Completed General Record Keeping, Correspondence and Reporting Yes No N/A Decoding procedures for blinded trials Yes No N/A Correspondence with other investigators, IRBs, sponsors, monitors, or FDA, including required reports Site Initiation report / visit documentation: Trial specific information is provided to the investigator and staff prior to study startup, as well as an Yes No N/A assessment of resources and capability to conduct study. The sponsor’s Monitors discuss study obligations under GCP and FDA (if applicable) requirements. The initiation report outlines the sites ability to adhere to these requirements as well as Studysponsor close-out policies, practices, report / visitand procedures documentation for the: conductThe close of out the report trial. / visit Yes No N/A documentation is filed once all subjects at that site have completed the study and all data queries have been resolved. The report contains a summary of study results, final participant enrollment status, significant findings, and any reportable Reportsinformation of resultingdeviations in increased from the risk/harm investigational to participants. plan: The investigator notifies the sponsor and the reviewing IRB of any deviation from the investigational plan to protect the life or physical well-being of a participant in an emergency. Such notice Yes No N/A is given as soon as possible, but in no event later than 5 working days after the emergency occurred. Except in such an emergency, prior approval by the sponsor is required for changes in or deviations from a plan, and if these changes or deviations may affect the scientific soundness of the plan or the rights, safety, or welfare of Progresshuman participants, reports: TheFDA investigator and IRB approval submits is required.progress reports on the investigation to Yes No N/A the sponsor, the monitor, the FDA (if applicable) and the reviewing IRB at regular intervals, but in no event less often than yearly. Inspection Reports (FDA Form 483): The FDA, Sponsor and/or internal auditing group determines the investigator’s compliance with the protocol, federal Yes No N/A regulations, and institutional policies through an inspection/audit of the investigator’s research facility, handing of investigational products (if applicable), and regulatory documentation. Inspection reports, including FDA Form 483, outlining observational findings and corrective actions may be issued as part of the inspection

HLMA Office of Human Research Administration Investigator Self-Assessment, version date: January 5, 2017 CHECKLIST: Investigator Self-Assessment

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HRP-430 1/5/2017 2 of 4

Reports of withdrawal of IRB approval: The investigator reports to the sponsor, Yes No N/A within 5 working days, a withdrawal of approval by the reviewing IRB of the investigator’s part of an investigation unless required sooner by the sponsor. Final Report: The Investigator, within 3 months after termination or completion of Yes No N/A the investigation or the investigator’s part of the investigation, submits a final report to the sponsor and the reviewing IRB unless required sooner by sponsor.

IND Studies No IND (Skip to section 5) Yes No FDA 1571: Current signed version Yes No FDA 1572: Current signed version Yes No N/A Previous versions of signed FDA 1572

Yes No Financial Disclosure (FDA 3455): Current, signed form submitted to the sponsor from each investigator listed on the 1572 Yes No N/A Previous versions of signed financial disclosure forms submitted to the sponsor from each investigator listed on the 1572 Yes No FDA 3674: Current signed Certification of Compliance with Requirements of ClinicalTrials.gov Data Bank Yes No N/A Previous versions of signed FDA 3674 Yes No N/A Investigator Brochure or product information, e.g., package insert or sample label: current version Yes No N/A Previous versions of or updates to the Investigator Brochure or product information Yes No N/A Instructions for handling of investigational product(s) and trial-related materials (if not in protocol or Investigator Brochure) Yes No N/A For marketed products, a package insert/product information Yes No N/A Drug Accountability Log for each drug under investigation

IND: Study Conduct Confirmation Yes No Investigator is responsible for the control of drugs under investigation

Yes No Investigator administers the drug only to participants under their personal supervision or under the supervision of a sub-investigator responsible to the Yes No Investigatorsinvestigator do not supply the investigational drug to any person not authorized to receive it If an investigational drug is participant to the Controlled Substances Act, Yes No N/A investigators take adequate precautions, including storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited, to prevent Iftheft the orinvestigation diversion of is the terminated, substance suspended, into illegal discontinued,channels of distribution or completed, Yes No N/A investigators return the unused supplies of the drug to the sponsor, or otherwise provides for disposition of the unused supplies of the drug as authorized by the HLMA Office of Human Researchsponsor Administration Investigator Self-Assessment, version date: January 5, 2017 CHECKLIST: Investigator Self-Assessment

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HRP-430 1/5/2017 3 of 4

Safety Reports are filed with the IRB, sponsor, and FDA as applicable. Reportable New Information (RNI) that must be reported to the IRB includes Yes No N/A adverse events or unanticipated problems involving risk to participants or others that are unexpected and at least possibly related to the research procedures. These events must be reported to the IRB within 5 business days from the time Adversethe study events team becomesthat are suspected aware of the to beinformation associated (OHRA with the policy). use of the drug that Yes No N/A are unexpected and fatal or life threatening, are reported to the IRB within 5 business days from the time the study team becomes aware of the information, reported to the sponsor according to the sponsor agreement, and reported to the AdverseFDA within events 7 calendar that are days suspected after the to IND be associatedholder is notified with the of usethe eventof the drug that Yes No N/A are both serious and unexpected are reported to the IRB within 5 business days from the time the study team becomes aware of the information, reported to the sponsor according to the sponsor agreement, and reported to the FDA by within 15 calendar days after the IND holder is notified of the event Yes No N/A Follow up information to safety reports is submitted to the IRB, sponsor, and FDA as soon as the information is available

IDE Studies No IDE Yes No FDA 1571: Current signed version Yes No Investigator Statement: Current signed version Yes No N/A Previous versions of signed Investigator Statements

Yes No Financial Disclosure (FDA 3455): Current signed form submitted to the sponsor from each investigator listed in the Investigator Statement Yes No N/A Previous versions of signed financial disclosure forms submitted to the sponsor from each investigator listed in the Investigator Statement Yes No FDA 3674: Current signed Certification of Compliance with Requirements of ClinicalTrials.gov Data Bank Yes No N/A Previous versions of signed FDA 3674 Yes No N/A Device manual or Report of Prior Investigations: Current version Yes No N/A Previous versions of or updates to the device manual or Report of Prior Investigations Yes No N/A Instructions for handling of investigational product(s) and trial-related materials (if not in protocol or Investigator Brochure) Yes No N/A For marketed products, a package insert/product information Yes No N/A Device Accountability Log for each device under investigation

IDE: Study Conduct Confirmation Yes No N/A Investigators permit an investigational device to be used only with participants under the investigator’s supervision Yes No N/A Investigators do not supply an investigational device to any person not authorized to receive it

HLMA Office of Human Research Administration Investigator Self-Assessment, version date: January 5, 2017 CHECKLIST: Investigator Self-Assessment

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HRP-430 1/5/2017 4 of 4

Upon completion or termination of a clinical investigation or the investigator’s part Yes No N/A of an investigation, or at the sponsor’s request, investigators return to the sponsor any unused device or otherwise dispose of the device as the sponsor directs Safety Reports are filed with the IRB, sponsor, and FDA as applicable. Reportable New Information (RNI) that must be reported to the IRB includes Yes No N/A adverse events or unanticipated problems involving risk to participants or others that are unexpected and at least possibly related to the research procedures. These events must be reported to the IRB within 5 business days from the time Unanticipatedthe study team Adverse becomes Device aware Effects of the (UADE)information (OHRA policy). i.e., any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree Yes No N/A of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. UADE are reported to the IRB within 5 business days from the time the study team becomes aware of the information, reported to the sponsor no later than 10 working days after the investigator first learns of the event, and reported to the FDA by within 10 Yes No N/A Follow up information to safety reports is submitted to the IRB, the sponsor, and the FDA (as applicable) as soon as the information is available

HLMA Office of Human Research Administration Investigator Self-Assessment, version date: January 5, 2017