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Office for Human Research Studies

DANA-FARBER / HARVARD CANCER CENTER OHRS Use Only:

DFCI Protocol No.:

NEW PROJECT APPLICATION for NON-CLINCIAL RESEARCH

This form must be used for new project proposals that involve non-clinical research.

Instructions to submit: 1. If this is the first submission of the Principal Investigator, please ensure they complete the applicable sections from the Training Checklist for New DF/HCC Researchers. In particular, the Principal Investigator will need to have an OnCore profile. 2. To gain system access to make the submission, please request Oncology Protocol System Access and OHRS Submit Access here. 3. Complete this form (typewritten). Please refer to the last section of this form to identify additional documents that will need to be completed prior to submission. 4. Submit all the submission documents through OHRS Submit. Incomplete applications will be returned.

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

If this is a resubmission of a previously disapproved or withdrawn study, please provide the prior protocol number: If this is a submission for IRB approval of an OncDRS data request, please provide the OncDRS number:

Part A – General Study Information Study Title

DF/HCC Principal Investigator Protocol [pull down] If Ancillary, provide parent protocol #: Type (CCSG determined)

Version: 10.02.2017b Office for Human Research Studies

DANA-FARBER / HARVARD CANCER CENTER Management Groups: These are the groups/programs that are running the trial and will be entered into OnCore as the Management Groups.

a. Please indicate the Primary Management Group for this study:

b. Please select all the Management Groups that apply (including the Primary group):

BIDMC DFCI/BCH DFCI/BWH MGH AIDS Malignancy Hematologic Malignancy Adult Non-Malignant Hematology Benign Hematology Benign Hematology Hematologic Stem Cell Transplant Adult Sarcoma and Bone Oncology Bone Marrow Transplantation Biologics (Kidney/Melanoma/Cutaneous) Neuro-Oncology Breast Oncology Breast Oncology Bone Marrow Transplant Non-Malignant Hematology Center for Cancer Precision Medicine Cell Therapy Breast Cancer Oncology: Perini Family Survivors Cutaneous Oncology Gastrointestinal Cancers Center Experimental (Phase I) Therapeutics Solid Tumor Gastrointestinal Oncology Genitourinary Cancers External Pediatric Other Genitourinary Oncology Gynecologic Cancers (Not Kidney / Not Prostate) Gastrointestinal & Hepatobiliary Gynecologic Oncology Head and Neck Cancers Genitourinary Oncology Head and Neck Oncology Leukemia Gynecologic Oncology Immuno-Oncology Lymphoma Leukemia Kidney Melanoma Lymphoma Leukemia Multiple Myeloma Myeloma Lymphoma Neuro-Oncology Neurologic Oncology Melanoma Pediatric Hematology and Oncology Radiation Oncology Multiple Myeloma Phase I Thoracic Oncology Neuro-Oncology Proton Therapy Other Phase I Sarcomas and Soft Tissue Tumors Pop Sci: Cancer Genetics Thoracic Cancer Pop Sci: Cantor Center Other Pop Sci: Community Based Research Pop Sci: Outcomes Research Population Sciences Prostate Psychosocial Oncology and Palliative Care Radiation Oncology Thoracic Oncology Transplant Adult Other

c. The management groups for participating sub-sites (non-primary) were confirmed with that sub-site: -Select-

Version: 10.02.2017b Office for Human Research Studies

DANA-FARBER / HARVARD CANCER CENTER d. Additional groups: i. BIDMC Clinical Trial Specialist - Select if BIDMC is participating in the research (Lead Site or Non-Lead Site) ii. DF/HCC Affiliate Site - Select if an affiliate site of DF/HCC is participating in the research (for a list of affiliates, see the OHRS Request to Add Site Checklist) iii. DF/HCC Satellite Site - Select if a satellite of DF/HCC is participating in the research (for a list of satellites, see the OHRS Request to Add Site Checklist) iv. MGH Regulatory Coordinators - Select if MGH is participating in the research (Lead Site or Non-Lead Site) and the Cancer Center Protocol Office (CCPO) will coordinate the trial. v. OTHER Registering Site - Select if a non-DF/HCC site is participating in the research (e.g., MD Anderson Cancer Center).

Part B – Sponsor Information 1. PRINCIPAL INVESTIGATOR INSTITUTION (Select Only One) Beth Israel Deaconess Medical Center (BIDMC) Beth Israel Deaconess Medical Center – Needham

Boston Children’s Hospital (BCH)

Brigham and Women’s Hospital (BWH) [Are you working with the DFCI CTO to submit this trial? If no, please contact Sarah White from Partners Research Management at: [email protected]]

Dana-Farber Cancer Institute (DFCI) Dana-Farber/Brigham and Women’s Cancer Center (DF/BWCC) at Milford Regional Medical Center (DFCI @ Milford) Dana-Farber/Brigham and Women’s Cancer Center (DF/BWCC) in clinical affiliation with South Shore Hospital (DFCI @ SSH) Dana-Farber/New Hampshire Oncology-Hematology (DFCI @ NHOH)

Massachusetts General Hospital (MGH) [Are you working with the MGH CCPO to submit this trial? If no, please contact Sarah White from Partners Research Management at: [email protected]] Massachusetts General Hospital at North Shore Cancer Center (MGH @ NSCC) Massachusetts General Hospital at Emerson Hospital (MGH @ EH) Massachusetts General Hospital at Newton-Wellesley Hospital (MGH @ NWH)

Other [Specify]:

Version: 10.02.2017b

2. INITIATOR OF THIS STUDY a. Who was responsible for the initial design and development of the study? (e.g., investigator, industry) b. Who will be responsible for the oversight and coordination of the trial, regardless of funding/drug support? [Note: If the DFCI or DF/HCC Investigator designed and will be responsible for the oversight of this study, Part D must also be completed.]

3. CTEP Study: Yes No

4. Regulatory Sponsor Study Number (If Applicable):

Part C – Study Overview 1. STUDY SUMMARY: Please summarize the proposed research using language understandable to those committee members whose primary expertise is not scientific. The summary must include: (1) A brief statement of the purpose, objective(s) and goal(s), background, significance, research design, and methods; (2) A brief description of the procedure(s) involving human study participants; and (3) The setting in which the research will be conducted.

2. Enrollment/Target Population a. Total number of study participants: b. DF/HCC total enrollment (if different from above): c. Are all genders, races and ethnicities eligible to participate in the study? Yes No, provide scientific rationale in the Inclusion/Exclusion Criteria section of the protocol

d. Does this research study involve children? Yes No, please provide the reason: The number of children with this type of cancer is limited No dosing or adverse event data are currently available on the use of this Study Agent in this way in patients less than 18 years of age, therefore, children are excluded from this study but will be eligible for future pediatric trials with Study Agent. Other:

3. Informed Consent: The protocol must include a description of the Informed Consent process and all consent information presented to subjects must be submitted to the IRB for review. The IRB may grant waivers or alterations to informed consent requirements if sufficient justification is provided. See DF/HCC CONS-100 and OHRS Guidance on Requirements for Informed Consent for additional information.

Select all mechanisms for obtaining informed consent for this study: Signed Consent Form Waiver of Documentation Waiver of Informed of Informed Consent Consent Subjects receive and sign a Subjects receive consent Subjects do not sign a consent document that outlines all information but do not sign a form and may not receive all elements of informed consent. consent form. required elements of informed consent.

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4. HIPAA Subjects must provide written Authorization for investigators to access their medical records. If the research requires a waiver or alteration of Authorization, please indicate the request for a waiver below. Sufficient justification MUST be included in the protocol.

Request for Waiver or Alteration to use or Disclose Protected Health Information in Research.

5. INFORMATION SECURITY a. Please describe who will manage study data (e.g. ODQ/CTRIO, External Sponsor, Study Team (no ODQ/CTRIO involvement), Combination of External Sponsor and Study Team):

b. Will data be managed using any study team created/managed databases? Yes No

c. Partners Healthcare Institutions – Have you completed a Research IS Risk Assessment? If applicable, please follow the instructions included in the link below for conducting a Research IS Risk Assessment: https://rc.partners.org/research-apps-and-services/security/research-risk-assessments Yes No

6. BIOPSIES a. Does this study involve mandatory research biopsies? No Yes. The protocol must indicate the number of required biopsies and contain statistical justification for the use of the mandatory research biopsies. This is required for all studies.

b. Does this study involve optional biopsies? No Yes. The Optional Studies section of the consent form must include the appropriate optional biopsy sign-offs using the format provided in the model consent form.

7. CLIA REQUIREMENTS: Will any portion of the Research be conducted in a Non-CLIA Approved Laboratory? No Yes. Please describe:

8. FDA REQUIREMENTS Does this study involve the use of an In Vitro Diagnostic Test and/or Laboratory Developed Test? For guidance please see: FDA Laboratory Developed Tests Webpage and FDA Discussion Paper on Laboratory Developed Tests (LDTs) Dated January 13, 2017). Please note, the FDA has exercised enforcement discretion over LDTs. No Yes. Please answer the following questions: a. Has the Sponsor-Investigator determined that this laboratory developed test, defined by the FDA as an investigational device, is exempt from the IDE Regulations? (For guidance please see: FDA Device Advice) No (Not-Exempt) Yes (Exempt)

b. If not-exempt, please provide the Sponsor-Investigator’s risk determination for this investigational device study: (For guidance please see: FDA Info Sheet on Significant Risk vs. Non-Significant Risk Device) - 5 -

Non-Significant Risk  Submit the Sponsor-Investigator’s rationale used in making this risk assessment (required)  If the FDA has issued a Non-Significant Risk Letter, please submit (if available)

Significant Risk  Submit the Sponsor-Investigator’s rationale used in making this risk assessment (required)  Submit the FDA IDE approval letter and number (required)  IND/IDE ID #:  IND/IDE Holder Type:  IND Holder Name:

Part D – Monitoring and Site Utilization

1. RESOURCES Describe the resources available to ensure adequate oversight of this study:

2. Identify all sites at which this research will be conducted: DF/HCC Sites and Satellites: Beth Israel Deaconess Medical Center (BIDMC) BIDMC at Needham Boston Children’s Hospital (BCH) Brigham and Women’s Hospital (BWH) BWH at Faulkner Hospital Dana-Farber Cancer Institute (DFCI) DFCI at Milford DFCI at St. Elizabeth’s DFCI at South Shore Dana-Farber/New Hampshire Oncology-Hematology DF/BWCC in Clinical Affiliation with South Shore Hospital Massachusetts General Hospital (MGH) MGH at North Shore MGH at Newton-Wellesley Hospital MGH / Emerson Hospital

DF/PCC Affiliates: Cape Cod Healthcare Lowell General Hospital New England Cancer Specialists

Other Sites under the DFCI IRB: Broad Institute Harvard Catalyst Members(s): Harvard Catalyst Members(s): Harvard Catalyst Members(s):

Multicenter Site(s) with Master Clinical Trials Agreements: Berkshire Medical Center Eastern Maine Medical Center Lifespan Stamford Hospital

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3. DF/HCC, SATELLITE, and AFFILIATE SITE UTILIZATION If this study will not be performed at any of the DF/HCC or DF/PCC affiliate sites (Institutional Participants under DFCI IRB) listed above, please explain why not:

4. DF/HCC INITIATED STUDY Does not apply – not DF/HCC Initiated Please complete questions (a) and (b) below if a DF/HCC Investigator (including Satellite or DF/PCC Affiliate Investigators) designed and will be responsible for the oversight of this trial, regardless of funding/drug support.

a) List all Institutional Participants under an Outside IRB that are expected to participate in the proposed study:

City, Federal Wide Assurance IRB of Record Institution Name: State/Country: (FWA) #: (if known):

1)

2)

3)

4)

5)

Please Note: . All multi-center participating sites must have a Federal Wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP). . To check an institution’s FWA # please go to the website: http://ohrp.cit.nih.gov/search/ . Please refer to DF/HCC SOP MULTI-100 and other associated multi-center documents on the DF/HCC Clinical Research Support Website for more information about conducting PI Initiated multi-center studies. . No research may be conducted at any outside multi-center sites without approval of an associated Add Site Amendment submission. Once the outside sites IRB approvals become available, the multi-center sites noted above should be added by submitting the Request to Add New Site form via OHRS submit.

b) Please explain why this study is being conducted as a multi-center study:

Part E – Additional OnCore Information 1. Key Personnel: a. Does this study have a DF/HCC Site Responsible Investigator? Yes No If yes, please complete the following: Name(s): Mgmt Group(s): Institution(s):

b. Does this study have a Primary Study Contact?: -Select- If yes, please complete the following: Name: Email: Phone: The Primary Study Contact has completed the required training (see EDU-100 Training Requirements for Research Personnel).

2. Study Participant Information a. Adult Age Range: Pediatric Age Range:

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b. Will all subjects be recruited from pediatric clinics? Yes No

c. If enrolling both adult and pediatric subjects, anticipated percent of pediatric subjects:

3.Protocol Involves (check all that apply as listed in the protocol document, even if not part of the research but is mandated by the protocol document): Data Repository Medical Record Review Exercise/Physical Therapy Questionnaires/Surveys/Interviews Genetic Studies Radiological Exams Human Material Banking Required Biopsy Study Human Material Collection Quality of Life Other:

4.Dates of Records (if applicable): Please indicate the range of dates of the records that will be reviewed: From: To:

Part F – Activation Information

A. OFFICE of DATA QUALITY (ODQ) [Formerly QACT (Quality Assurance Office for Clinical Trials)]

1. CLINICALTRIALS.GOV REGISTRATION OF INVESTIGATOR INITIATED TRIALS DF/HCC requires Clinicaltrials.gov registration of all Investigator-Sponsored Interventional trials regardless of phase in order to meet the following requirements; The Food and Drug Administration Amendments Act of 2007 (FDAAA), the Sunshine Act of 2010, Health and Human Service Final Rule (2017), NIH Rule (2017) and or the International Committee of Medical Journals of Editors (ICMJE) requirements. These trials include but are not limited to Prevention, Supportive Care-Intervention, Diagnostic-Intervention, Screening-Intervention and Health Service Research-Intervention. For the above the trials and any trial indicated below where the PI determines registration is necessary or desired, ODQ will facilitate the initial registration process of ClinicalTrials.gov. Please contact ODQ if you have any questions regarding Clinicaltrials.gov registration at [email protected].

Guidance for requirements and registration can be found at http://www.dfhcc.harvard.edu/research/clinical-research- support/office-of-data-quality/ctgov-ctrp-national-protocol-registration/

If the answer to any of the below is “Yes”, the trial will need to be registered on ClinicalTrials.gov. 1) Is this an Investigator-Sponsored Trial? N Y If you answered “no” to this question, please skip to question #2. a) Is this a Supportive Care-Interventional Trial? Definition per FDAAA: “protocol designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or mitigate against a decline N Y in the subject’s health or function. In general, supportive care interventions are not intended to cure a disease.” b) Is this a Prevention-Intervention Trial? Definition per FDAAA: “protocol designed to assess one or more interventions aimed at preventing the N Y development of a specific disease or health condition.” c) Is this a Diagnostic –Intervention trial? Definition per FDAAA: “protocol designed to evaluate one or more interventions aimed at identifying a disease or N Y health condition.” d) Is this a Screening-Intervention Trial? Definition per FDAAA: “protocol designed to assess or examine methods of identifying a condition (or risk factors N Y for a condition) if people who are not yet known to have the condition (or risk factor.)”

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e) Is this a Health Service Research-Intervention Trial? Definition per FDAAA: “protocol designed to evaluate the delivery processes, management N Y organization or financing of health care.” 2) Is the trial wholly or partially federally sponsored/NIH funded where a N Y DF/HCC Investigator is the grantee? 3) If the trial does not meet the requirements above, do you still want this trial to be registered with Clinicaltrials.gov? (please see Clinicaltrials.gov for N Y guidance) 4) If yes to any of the above questions, please provide the Anticipated Primary Completion Date. Definition per FDAAA: “the date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical study concluded according to the pre-specified (mm/dd/yy) protocol or was terminated.” 5) If yes to any of the above questions, please provide the Anticipated Study Completion Date. Definition per FDAAA: ”the date the final participant was examined

or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (for example, last participant’s last (mm/dd/yy) visit), whether the clinical study concluded according to the pre-specified protocol or was terminated.”

2. REGISTRATION, RANDOMIZATION AND CASE REPORT FORMS a) Will study participants be registered in the DF/HCC OnCore Clinical Trial Management system? No. Yes. If yes, mark here if the protocol contains eligibility (e.g., inclusion/exclusion) criteria. An eligibility checklist is required. The lead study team must create an Eligibility Checklist per DF/HCC SOP REGIST- 100 and submit the checklist with this new protocol application.

b) Will the ODQ randomize this study? Yes. (If yes, please ensure that the protocol document states that ODQ will randomize subjects.) No.

B. Clinical Trials Research Informatics Office (CTRIO) [Formerly QACT (Quality Assurance Office for Clinical Trials)] 1. Will CTRIO develop Case Report Forms for this study? Yes No

C. PATHOLOGY REVIEW

1. Biological Specimens a) Does this study include the research use of biological specimens? No Yes

b) If “yes”, please answer the following: 1) Specify the type of specimen (e.g. blood, serum, and tissue): a) If using tissue, please specify:

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Fresh Frozen Paraffin embedded (tissue sections) Other: b) If using tissue, please identify at which institution the tissue will be collected: DFCI/BWH BIDMC BCH (If selected, please attach the BCH “discarded” tissue form available from the BCH Pathology Department) MGH c) If using Pathology services from one of the DF/HCC institutions listed in C(b)(1)(b) above, please confirm that the office managing the budgets have been advised and the budget includes the costs for Pathology services: Yes No – If no, please explain why the budget does not cover pathology services:

2) Will specimens be banked for use beyond this study? No Yes 3) Will the specimen testing/drawing be an optional part of the study? No Yes 4) May study participants request that their samples be destroyed in the future? No Yes 5) Will specimens be linked to study participants’ identities? No Yes 6) Describe who will have access to these specimens: 7) How long will these specimens be maintained?

D. DFCI PATHWAYS (DFCI-led studies only) Should this study be listed in the DFCI Pathways system? For questions regarding the Pathways program, please contact, [email protected]. N/A No Yes

E. BELFER OFFICE FOR DANA-FARBER INNOVATIONS (BODFI activation sign-off required for DFCI-led studies only, however, please consider including a plan for the sharing of samples in all protocols.) 1. Will samples be transferred to any sites outside of the lead site (including Broad Institute)? Please note that a plan for transferring samples between sites both within and outside of DF/HCC must be included in the protocol. This must also be appropriately disclosed to participants in the informed consent. No Yes 2. If yes, please provide information on the sources of funding for the sample collection and the contemplated collaboration upon sample transfer: (N/A )

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Part G – Priority List Placement Please complete the table below to indicate the placement of this protocol within the current priority list from ONCPRO; references to main disease group, category, and if applicable, sub- category and modality must correspond to the formal names cited on ONCPRO.

Guidance for priority list: http://www.dfhcc.harvard.edu/crs-resources/OHRS_Documents/02_- _Investigator_Resources/IS_-_Operations_-_Guidance_Priority_List.pdf

Modality Placed Subcategory Adult / (if Befor (if Add New Pediatric Main Disease Group Category appli e applicable cable Proto ) ) col #

e.g. Adult Non-Intervention Data Repository N/A N/A xx-xxx

1)

2)

3)

4)

5)

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Part H - Signatures

As DF/HCC Check ifPrincipal N/A. Required Investigator, only if my an signatureEndorsement below Form provides is also written required. assurance Please thatrefer I tohave the reviewed New the New ProjectProtocol Application, Submission protocol, Requirement consent form, Chart and to determinerequired supplemental whether endorsement forms and isconfirmed required forthat your the information providedstudy. is accurate. My signature also assures that identifiable information will not be reused or disclosed except as required by law; for authorized oversight of research; or for other research only if that research has been reviewed My andsignature approved below by providesthe DFCI written IRB with assurance specific attentionthat I have to reviewedand approval the proposedof the issue study of accesswith the to appropriatethis identifiable diseaseinformation. program members and find that it meets the goals and priorities of this disease program and does not compete with currently active trials. My signature further verifies that none of my active research studies are suspended due to expired IRB approval. If studies are expired, then I confirm a Continuing Review has been submitted to OHRS and it is pending ______review/approval. ______Endorsing Signature Date Print name ______Signature of Overall DF/HCC Principal Investigator Date Print name

New Project Application completed and/or submitted by:

Name: Date:

Phone: E-mail:

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Part I – New Application Submission Checklist Please include all items with your submission to the Office for Human Research Studies (OHRS).  This page must be completed or the application will be returned.  Missing documents will delay acceptance of your submission.  For documents requiring signatures, please either scan signed version for submission or submit with electronic signature.

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Submitted Not (Required if Form and description Applicable applicable)

New Project Application Form – Non-Clinical (Completed and signed)

Endorsement Form signed by Program Leader (Required as per the Completing Endorsement Forms Information Sheet).

Protocol document  Please consider using the “Data/Specimen Collection and Use” or the “Non-clinical Research” template.  Please note that the grant application is NOT a protocol document and information from the grant should not be pasted into the protocol.

Research Funding Form

Statement of Investigator Form(s)  One is always required for the Principal Investigator  If there are other DF/HCC sites, then each Site Responsible Investigator must complete this form also.  Scan signed versions as one document for submission via OHRS Submit

Co-Investigator Forms (DO NOT SUBMIT – confirm all Co-Investigator forms have been received and filed in the Lead Site Regulatory Binder.

Research Team Update Form  Please include all research team members (excluding the Overall PI/Site PI/ Primary Study) and any group mailboxes that will need to receive email communications about this trial.  These individuals will not be added to the protocol front sheet.

Outside Interest Log Sheet for all applicable Investigators and Research Team Members.

Consent form(s)/eConsent materials/Verbal Consent guide(s)  The IRB must review and approve all consent information provided to subjects.  For DF/HCC PI-Initiated Social/Behavioral trials, please consider using the Social and Behavioral Consent Template.

Model consent template (Required for Multi-Site Studies)

Recruitment materials ((The IRB must review and approve all recruitment materials, including guides outlining information given verbally to potential subjects.)

Test Instruments; surveys, interview guides, validated measures, drug diaries, etc.

DF/HCC Eligibility Checklists An Eligibility Checklist must be created by the study team using the DF/HCC Eligibility Checklist Template, in accordance with DF/HCC SOP REGIST-100, and be submitted as part of this new protocol application.

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Submitted Not (Required if Form and description Applicable applicable) Federal Grant Application – excluding appendices (Required if a project receives Federal funds)

Department of Defense Supplement Form Required for all trials which receive any funding from the Department of Defense.

Waiver of HIPAA Authorization Form. If you are requesting a Waiver of HIPAA Authorization please complete and submit the HIPAA Authorization form.

Multi-Center Approval for DF/HCC PI-Initiated trials that plan to be multi-center at any time.  Approval documents must be obtained prior to submission. Please see the ODQ guidance for details.  Approval can be in the form of the Investigator-Sponsored Multi-Center Trial Institutional Review Form (new process) or a non-expired Multi-center Coordinating Committee approval (former process).

BIDMC Confirmation of Investigator Resources Form. This form is required for all studies where BIDMC or its satellite sites are participating.

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