Dana-Farber / Harvard Cancer Center

Office for Human Research Studies

DANA-FARBER / HARVARD CANCER CENTER

Endorsement Form

Overview:

An Endorsement Form must be submitted with Cancer-related new clinical trial applications as well as new protocol applications for a prospective collection of human specimens/data.

For pediatric protocols, the investigator should prepare a draft endorsement form and submit to OHRS. At the time of PSRC review the Chair of the PSRC will finalize the form based upon PSRC review. A copy of the final form will be sent to the disease/discipline based program leaders.

A list of Disease or Discipline-Based Program Leaders and Clinical Trial Chairs, who may sign this form, is posted on the DF/HCC website: http://www.dfhcc.harvard.edu/crs-resources/OHRS_Documents/02_-_Investigator_Resources/Program_Leader_List_for_Endorsement_Forms.pdf

This list also includes signatories for nursing initiated/focused studies.

Cancer-related new project applications will not be processed without this form.
Major Amendments: Please note that the IRB or the SRC may require an updated endorsement form in conjunction with an amendment that proposes significant changes to the study design, e.g., adding a participant population, or significantly changing the treatment regimen, or significantly changing the objectives of the study.

Part A – General Information

1. Name of Principal Investigator:

2. Full Protocol Title:

3. DF/HCC Disease or Discipline Based Program:

Disease Program: [pull down]Breast CancerCutaneous OncologyGastrointestinal CancerGynecological CancerHead & Neck CancerKidney Cancer (renal/non-prostate GU)LeukemiaLung Cancer (thoracic)Lymphoma & MyelomaMelanomaNeuro-OncologyNon-CancerPediatric OncologyProstate CancerSarcoma Program -OR- Discipline Program: [pull down]BiostatisticsCancer Cell BiologyCancer DisparitiesCancer EpidemiologyCancer GeneticsCancer ImagingCancer ImmunologyCancer NursingCancer Risk ReductionCancer SurvivorshipChemopreventionInvasion, Metastasis, AngiogenesisOutcomes ResearchPalliative CarePediatric OncologyRadiation OncologySurgical OncologyTranslational Pharmacology/Early TherapeuticsTransplant

4. If this is research (a) conducted under a discipline-based program that will span one or more disease programs or (b) involving more than one disease program, please confirm that the leaders of all disease-based programs have been notified of the research and have agreed to have it conducted with their subject population.

N/A

Yes. The multiple disease programs include:

No. If your answer is no, please explain:

Part B – Protocol Information

1.  What is the overall scientific merit of the proposed new trial?

Part C – Protocol Priority & Competing Trials

1.  How many patients are seen within DF/HCC in a year who would likely be eligible for this proposed research?

1. Does this study target a rare disease, i.e. 6 or fewer cases out of 100,000 people per year?
   Yes No

2.  What existing trials target the same population? For each of these trials list the target accrual and the accrual to date.

1. Given that there are existing trials targeting the same population, why is this trial necessary?

1. In the past year, have any of these existing trials been closed or questioned by any DF/HCC committee or outside DSMC or DSMB regarding low accrual and if so, please describe what occurred.

3.  In summary, what is the priority of this trial with respect to other open trials?

4.  Will it be feasible to complete the study within the timeframes described in the protocol?
Yes No

5.  Please provide any additional information that will be helpful to the committee in reviewing this protocol.

Part D – Institutional Participation and Study Support

1. Is this a multi-center trial with:

a) A DF/HCC PI as the sponsor? No Yes

b) An outside sponsor? No Yes. Sponsor Name:

2. What are the sources of support for this research?

3. What is the Overall target accrual?

4. What is the DF/HCC target accrual?

5. The DF/HCC operates as a consortium and the expectation is that the research will be conducted at all appropriate DF/HCC institutions.

·  It is not acceptable for a trial not to be offered because a sponsor only wants to conduct the research at one institution.

·  Slowly or rapidly accruing protocols are identified and monitored by the Scientific Review Committee. Please see DF/HCC SOP COM-102 for more information.

a.  Identify all sites under the DFCI IRB at which this research will be conducted and the anticipated number of accruals at each site:

DF/HCC Sites and Satellites: / Projected Accrual(s): /
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
Total:
DF/PCC Affiliates: / Projected Accrual(s):
Cape Cod Healthcare
Lowell General Hospital
New England Cancer Specialists
Total:
Other Sites under the DFCI IRB: / Projected Accrual(s):
Broad Institute
Harvard Catalyst Members(s):
Harvard Catalyst Members(s):
Harvard Catalyst Members(s):
Total:

b.  If any of the DF/HCC institutions will not participate, one or more of the following conditions must be met: (check as applicable)

1.  The study is open at two or more centers other than DF/HCC, enrollment is competitive, and the study has a "run in" phase (or dose escalation phase for a phase I study) involving a limited number of subjects that will be accrued within the DF/HCC institutions (e.g., less than or equal to 10) that makes it more efficient to be conducted at only one institution as opposed to broadly throughout DF/HCC. Please describe:

2.  A restriction is agreed upon within the disease program (or phase I group), at a meeting represented by relevant consortium members (e.g., BIDMC, BCH, BWH, DFCI, MGH, etc).

Date(s) Discussed: Please describe:

3.  Once the "run in" phase is completed, if the study proceeds to an expansion phase (either in a phase I setting, or a phase I-II transition), the study will be made broadly available throughout DF/HCC at that time. Please submit documentation from the sponsor that this has been explicitly addressed.

4.  Other. Please explain the specific reason for excluding member DF/HCC sites here (e.g., institutional conflict of interest; resources at the other institutions are already dedicated to other trials; or a competing trial is ongoing, etc.):

c.  Sites with Master Clinical Trials Agreements: Participation of collaborative members including Berkshire Medical Center, Eastern Maine Medical Center, Lifespan, and Stamford Hospital is strongly encouraged. Note: Dana-Farber Cancer Institute must be a participating site to add any of these Multicenter Sites.

N/A (the trial is not a DFCI Investigator-sponsored study)

If applicable, please explain why these sites have not been included:

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

d.  DF/HCC investigator-sponsored studies expecting to enroll participants under an Outside IRB:

N/A (the trial is not a DF/HCC Investigator-sponsored study)

§  Please refer to DF/HCC MULTI-100 and other associated multi-center documents for more information about conducting investigator-sponsored, multi-center studies.

§  Institutional multi-center approval must be submitted to OHRS as part of this application.

§  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 below should be added by submitting the Request to Add New Site form via OHRS submit.

Please explain why there are not enough participants within the DF/HCC and associated entities to justify conducting this as a multi-center trial.

Other External Sites:

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

§  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 institutions FWA # please go to the website: http://ohrp.cit.nih.gov/search/

Part E – Endorsement Signatures

I. BiostatisticAN Endorsement: (Required for DF/HCC Investigator-sponsored Clinical Research Only):

Choose one:

I have reviewed this protocol and there continue to be concerns regarding the biostatistical section. There are pages of comments attached.

I have reviewed this proposed research and provide assurance that the biostatistical sections of the protocol are complete and ready for review by the scientific review committee. There are pages of comments attached. Specifically:

I agree that the protocol contains clear primary and secondary objectives that can be measured with objective endpoints and the endpoints are defined.

I agree that the sample size is clearly stated and quantitatively justified in the statistical section of the protocol and it relates directly to at least the primary objective of the study.

Signature of Study Biostatistician Date

Name:

II. Disease or Discipline Program Leader (or Clinical Trials Subcommittee Chair):

If any Disease or Discipline Program Leader (or Clinical Trials Subcommittee Chair) has an equity interest with the sponsor of this research, the protocol may not be submitted until a management plan has been developed by the Conflict of Interest (COI) Official at the applicable institution. The Conflict of Interest Official should also sign below to indicate that a management plan has been developed.

I do not have an equity interest with the sponsor of this research.

I have an equity interest with the sponsor of this research. Institutional COI Official Signature is required confirming that a COI management plan has been developed:

Signature of Conflicts of Interest Official Date

Name:

On behalf of the Disease or Discipline-Based Program, I have reviewed this proposed research and provide assurance that this proposed research fits within the mission of the program and is supported by programmatic and clinical trials leadership within the research program:

Program Leader Endorsing Signature Date

Name:

Name:

III. Pediatric Scientific Review Committee Endorsement:

For Pediatric Trials, on behalf the Pediatric Scientific Review Committee, the proposed research fits within the mission of the program and is supported by programmatic and clinical trials leadership within the research program:

Signature of Pediatric Scientific Review Committee Chair or Designee Date

Name:

Name:

Endorsement Form

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