Statement of PI for New Projects

Office for Human Research Studies

DANA-FARBER / HARVARD CANCER CENTER DFCI Protocol No.:

OHRS USE ONLY CR #: Expiration Date:

Application for Continuing Review – Single IRB

Use this form to provide OHRS notification of Central IRB continuing review approval as well as to update study conduct information.

Please contact the OHRS at (617) 632-3029 or by email [email protected] with any questions.

1. Part A – STUDY INFORMATION Protocol Short Title: Today’s Date:

Overall Principal Investigator: Institution: [First Name, Middle Initial, Last Name, Degree(s)] [PI Institution] Phone: Pager: 2. Part B – STUDY STAFF TRAINING Please check the boxes below to indicate that all study staff have completed the required training. Please refer to the study staff list for current Human Subject Protection (HSP) and Good Clinical Practice (GCP) training dates by clicking the “Active Staff” link associated with this study in OncPro .

Please do not submit this Continuing Review until the required training has been completed for all applicable staff. Submitting the Continuing Review before all staff have completed training will result in a returned submission.. Please reference DF/HCC SOP EDU-102 and EDU-103 to confirm the required training for this study. Please direct all questions about training to Marie Iannone in the Office of Data Quality.

1. All study staff have completed Human Subjects Protection training. 2. All applicable investigators have completed Good Clinical Practice training.

Note: Study Teams with permission to add study staff directly into OnCore, are responsible for ensuring that study staff are up to date in OnCore. OHRS will not process Research Team Update forms for study teams that can otherwise add / remove staff directly into OnCore.

3. Part C – PROJECT STATUS

 Please choose only one project status.  If this study has expired and any research has continued after the expiration date, please file a protocol violation describing any research that continued after the research expired.

1. Not Activated Yet. (Central IRB approved and accepted by the DFCI IRB, but not activated locally due to outstanding administrative requirements.) Please explain why the study has not been activated:

Application for Continuing Review – Central IRB - 1 - Version: 02.03.17a Please explain why this study should not be administratively withdrawn by OHRS:

2. Study Activated but No Enrollment to Date. Please explain why the study has accrued no subjects:

3. Enrolling Participants. (Study is actively accruing locally under a Central IRB and study interventions continue.)

4. Temporarily Closed to Enrollment Date Closed to Enrollment: Reason for Temporary Closure: If this is the first notification of closure to OHRS, please submit a Closure/Reopen form via OHRS Submit. The study will not be closed until the Closure Amendment has been submitted and processed.

5. Permanently Closed to Enrollment and Research Interventions Continue: Date Closed to Enrollment: If this is the first notification of closure to OHRS, please submit a Closure/Reopen form via OHRS Submit. The study will not be closed until the Closure Amendment has been submitted and processed. Please select only one: Treatment Continues Active Follow-Up Continues, but No Active Treatment (Participants are actively participating in follow-up e.g. Weekly clinic visits; research scans, etc.)

6. Permanently Closed to Enrollment and Research Interventions have Ceased: Date Closed to Enrollment: If this is the first notification of closure to OHRS, please submit a Closure/Reopen form via OHRS Submit. The study will not be closed until the Closure Amendment has been submitted and processed. Please select only one: Long Term/Survival Follow-up of Participants Continues First Report of a Status Change to Data Analysis Only (Please note that the consent form will be removed from OncPro at the time this continuing review approval is posted.) 7. Previously Reported as being in a Status of Data-Analysis Only and Data Analysis Continues: Closed to Enrollment, All Research Interventions have Ceased, All Data has been Collected and Data Analysis Continues.  If this continuing review was not previously submitted with a status of “Data Analysis Only” please select “First Report of a Status Change to Data Analysis Only” (Part C, Question 5).  Skip to Part I (Parts D through H do not need to be completed).  If a consent form is currently posted to OncPro for this study, it will be removed at the time this continuing review approval is posted.

4. Part D – STUDY ACCRUAL INFORMATION

 The accrual provided in questions 3, 4 and 5 should be equal to the OnCore data on file as of the date provided in question 1 (if participants are registered with ODQ once they sign consent).  Please specify the number of enrolled participants as either adult and/or pediatric. If a pediatric subject has now reached the age of 18 (or older) please refer the OHRS Information Sheet: “Consent for Continued Participation in a Research Study by a Young Adult Who Has Reached Age 18” for information on requirements for re-consenting.

1. Date accrual information obtained:

2. How many total participants have been enrolled globally, study wide (including all participating sites):

3. a. DF/HCC Accrual (Enrolling under Central IRB):  DF/HCC Accrual includes BCH, BIDMC, BWH, DFCI, MGH and related satellite sites.  Satellite site accrual should be recorded under the primary DF/HCC institution, DFCI or MGH.  Check off each participating site and include the accrual information to the right specifying subject population.

Total DF/HCC accrual:

Beth Israel Deaconess Medical Center (BIDMC): Adult: Pediatric: Beth Israel Deaconess Medical Center - Needham Beth Israel Deaconess Medical Center - Plymouth Adult: Pediatric: Boston Children’s Hospital (BCH): Brigham and Women’s Hospital (BWH): Adult: Pediatric: Dana-Farber Cancer Institute (DFCI), including Adult: Pediatric: satellites: Dana-Farber/New Hampshire Oncology-Hematology DF/BWCC at Milford Regional Medical Center DF/BWCC at South Shore Hospital Dana-Farber at Steward St. Elizabeth’s Medical Center Massachusetts General Hospital (MGH), Adult: Pediatric: including satellites: Mass General/North Shore Cancer Center Mass General at Emerson Hospital - Bethke

4. Has the DF/HCC accrual been increased in OnCore since the last Continuing Review? As applicable, OHRS will update OnCore and generate a new Front sheet. Please provide the new DF/HCC accrual goal: Please provide the date this increase in DF/HCC accrual was approved:

5. *Have you had any difficulties with enrollment or participant retention on this study?

Application for Continuing Review – Central IRB - 3 - 5. Part E – OVERALL STUDY PROGRESS

 This section is intended to capture the overall progress of the study, including scientific progress of the study, any unanticipated problems, current risk/benefit status and any new information that may be relevant to the disease or agent under investigation.  Note: starred “*” questions will be reviewed by the SPRC.

1. * Scientific Progress: a. Please provide an overall summary to date. Please provide a summary of the study progress to date regardless of whether or not the study has been analyzed or published. The summary or findings should include information about all participants enrolled on the study regardless of IRB of Record. Cooperative group, Consortia and Multi-Center Protocols require that the annual Study Wide Summary or Progress Report also be submitted for review.

b. Please provide a summary of local subjects for Scientific Progress Review Please include the status of all local subject such as how many are on treatment, in follow-up and off study:

c. Does the PI or other investigators serve as the Study Chair for the study or have any authorship of the protocol?

d. Please provide references for all publications: If the data from this particular study has been analyzed and/or published please either submit a copy of the analysis for review and/or provide the publication reference information below.

e. Please justify why this study is still scientifically valid: Please include information about any new findings or literature that may have affected the relevance of this study.

2. *Unanticipated Problems Involving Risks to Subjects or Others: Provide a summary of any unanticipated problems (not including reported adverse events) or events that have or have not been previously reported to the IRB. For example, a participant received the wrong study drug or incorrect dose. Summary Not Applicable (There have been no unanticipated problems or risks on this study.) Summary:

a. Have all unanticipated problems or risks been reported to the IRB? If no, please specify what has not been reported to the IRB previously and why:

3. Have all reportable SAE’s been reported to the IRB? If no, please specify what has not been reported to the IRB previously and why:

4. Summarize the minor deviation/violation log:

If any Minor Deviations/Violations have occurred since the last continuing review then the completed Log must be submitted with the continuing review form and an overall summary of those other events must be provided here. There have been no minor deviations/violations to report since the last continuing review. Summary:

Please confirm that as the Principal Investigator you have reviewed all of the Minor Deviations/Violations recorded on the Log since the beginning of the study. Please also determine that those events, which have not already been submitted as major events, do not impact the safety of participants; do not compromise the integrity of the study data, and do not affect subject’s willingness to participate in the study (choose one): Not Applicable. There have been no minor deviations/violations ever reported on this study. The events reported on the log meet the criteria outlined above and do not need to be reported as Major Events The following events need to be submitted to the IRB as Major Events (please specify):

5. Summarize briefly the major amendments made to the study since the last continuing review submission or initial review if this is the first continuing review submission. Please provide the date the amendment was submitted to the OHRS for review as well as the review outcome. Study team updates or editorial changes to the protocol or consent forms do not need to be noted here, unless they affect the scientific goals or the safety of this study.

a. *Did any of the study amendments alter the scientific goals of the study? Summary Not Applicable (None of the major amendments altered the scientific goals of the study.) Summary:

b. *Did any of the study amendments alter the safety of the study? Summary Not Applicable (None of the major amendments altered the safety of the study.) Summary:

6. Part F – CONFLICT OF INTEREST / HIPAA COMPLIANCE / OTHER

 According to the Privacy Rule (HIPAA), any disclosures made on or after April 14, 2003 of protected health information (PHI) outside of the covered entity or to institutions/individuals not listed in the authorization signed by the participant, must be accounted for and tracked by the study team for a period of 6 years.

1. Have there been any changes in conflict of interest disclosure information since the initial or last continuing review that are or may be relevant to the review of this protocol? If yes, please ensure the “Report of a Change in Outside Interest(s)” form has been completed and submitted via OHRS submit for IRB review. If yes, please also describe the changes briefly here:

2. Have there been any disclosures of PHI to individuals/groups outside of the covered entity:

Application for Continuing Review – Central IRB - 5 - If yes, these disclosures must be tracked by the study team as required under the HIPAA Privacy Rule. Can you confirm that all disclosures have been tracked?

3. Have there been any changes to the funding of this study? If yes, describe:

4. Have there ever been any site visits from the FDA relating to this study? a) If yes, please include the date(s): b) Have any FDA 483 or warning letters been issued as a result? If yes, please provide a copy of any such FDA documentation.

7. PART G – REQUIRED DOCUMENTS

 Documents listed below may be required at the time of submission.  A continuing review may be sent back to a study team for failure to submit the required documents and may result in a delayed review and approval. If you are unsure of whether or not a document specified below is required, please contact the OHRS.

Minor Deviations or Violations: Submit the Minor Deviation/Violation Log (Part D) Central IRB Approval Documentation (Required) Submit the most recent Central IRB approval memo for the study. Cooperative Group and Multi-Center studies: Submit the most recent study-wide summary (Part D) Report of a Change in Outside Interest(s) (Part E) Front Sheet: OHRS will need to generate a new Front Sheet because the local accrual has increased. Supplemental Study Information: Submit a copy of the relevant supplemental study information.

8. Part H – STATEMENT OF INVESTIGATOR Form completed by: Name: Date:

Phone:

E-mail:

By submitting this continuing review the Overall Principal Investigator assures that:

The information provided in this submission is complete and accurate, and that it is consistent with proposal(s) submitted to external funding agencies. All activities will be performed in accordance with state and federal regulations and Dana- Farber/Harvard Cancer Center Policies and Procedures

Responses have been submitted to any required follow-up on IRB reviewed events reported during the conduct of the study. (For example, the IRB sometimes requests further information regarding a Adverse Event (AE) or an Other Event (OE) that has been submitted for IRB review. If the study team has not submitted a response, this will hold up the continuing review.) During the course of the study, if you stated that an issue would be handled with the submission of a future amendment, the amendment has been submitted. You have read and understand the Dana-Farber/Harvard Cancer (DF/HCC) Guidance on Central IRB Review Process and have reviewed the information with the research team. All study staff have completed Human Subjects Protection training. (Before checking this box, please refer to the study staff list with current HSP training dates by clicking the “Active Staff” link associated with this study in OncPro .)

If any box is not checked please explain why:

Name of Overall Principal Investigator:

Application for Continuing Review – Central IRB - 7 -