Protocol Review & Monitoring Committee [PRMC]
Study # PI Name:Sponsor Name: Sponsor Study # Protocol Version Date:
Title:
ENROLLMENT: Is this study a Multi-Institutional Trial ? Yes No
Total # of TOTAL # of participants to be accrued in this trial from ALL SITES:
Proposed TOTAL # of participants be accrued LOCALLY: = “A”
Expected Time to Complete LocalAccrual (years): = “B”
Expected Annual Local Accrual (A/B):
*please indicate * Please indicate if your expected time to complete accrual is less than one year or otherwise a fraction of multiple years (for annual continuation purposes)
*Please *pleas
*Please provide realistic accrual numbers for expected enrollment overall and per year, numbers submitted to IRB will be different as PRMC does not take into account screen failures.
Short Title (<98 characters):
Objective/Purpose:
Trial Priority: selectLowMediumHigh
Justification of Prioritization Selected (why is it important to open this protocol at NYU at this time?):
Program Priority Schema is Attached (for example please see webpage)
Disease Stage(S) Study PhaseselectPilot121/232/34N/A
Disease Site (A-L) select one BONES AND JOINTS BRAIN & NERVOUS SYSTEM HODGKINS LYMPHOMA LEUKEMIA, NOS KAPOSI'S SARCOMA LARYNX KIDNEY LYMPHOID LEUKEMIA EYE & ORBIT LIP, ORAL CAVITY & PHARYNX LIVER LUNG ANUS CORPUS UTERI ILL-DEFINED SITES BREAST-MALE COLON ESOPHOGUS BREAST-FEMALE CERVIX (M-Z) select oneMelanoma, skinMultiple MyelomaMultiple SitesMycosis FungoidesMyeloid and Monocytic LeukemiaNon-Hodgkin’s LymphomaOther Digestive ORganOther Endocrine SystemOther Female GenitalOther HematopoieticOther Male GenitalOtherRespiratory and Intrathorasic OrgansOther SkinOther UrinaryOvaryPancreasProstateRectumSmall IntestineSoft TissueStomachThyroidUnknown SitesUrinary Bladder
Histology (A-K) select ADENOCARCIMOMA AML ADENOID CYSTIC ANAPLASTIC ASTROCYTOMA CARCINOMA BASAL CELL CLEAR CELL CLL DIFFUSE CELL EMBRYONAL ENDOMETRIOID EWING'S SARCOMA FOLLICULAR LYMPHOMA GLIOMA GRANULOSA CELL HEPATOCELLULAR HEPATPBLASTOMA (L-O) select MULTIPLE MULTIPLE MYELOMA MYELOID NEUROBLASTOMA ONCOCYTOMA OSTEOSARCOMA MEDULLARY MENINGIOMA MELANOMA MANTEL CELL LYMPHOMA MDS MIXED TUMOR LEYDIG CELL MEDULLOBLASTOMA LEUKEMIA LYMPHOID MUCOEPIDERMOID NSCLC NHL N/A (P-Z)selectPapillary serousPapillary Serous AdenocarcinomaPMLPNETpremalignant lesionsPseudomyxomarenal cellrhabdomyosarcomasarcomaSCLCseminomaSerous serous adenocarcinomaSerous Carcinomaserous cystadenocarcinomasoft tissue sarcomasquamous celltransitional celltubularunspecifiedWilms Tumor
Type of study : Pilot Single-blind Double-blind Open-label N/A Other:
lOCATION(s)
NYUMC (Tisch Hospital)
Bellevue Hospital*
NYU Cancer Center
NYU Langone Arena Oncology / NYU 38th St Outpatient Surgery
Smilow Comprehensive Prostate Cancer Center
Radiology 650 1st Ave / CTSI
Hassenfield Children’s Center
VA Medical Center
Other; specify:
NOTE: If your study is not a clinical TRIAL(chart review/ database/ registry/ tissue/image/survey etc.)
please use the non-interventionalprotocol application :
Is NYU DSMC the monitoring entity?(must choose one)selectYESNO
If nO, PLEASE PROVIDE THE NAME OF THE External Monitor: PI cannot monitor his/her own trial
* NCI Sponsor Type: Choose One of the following:
National Cooperative Group: ECOG, GOG, COG , SWOG, RTOG, etc .(If Nat’ Cooperative Group, Investigator Initiated?)
Externally Peer Reviewed : R01s and PO1s or other trial mechanisms funded by NIH or supported by other peer-reviewed funding organizations
Institutional: (Investigator Initiated Trial) In- House trials Authored or co-authored by CI Investigators who have primary responsibility for conceptualizing, designing and implementing the trial and reporting results (Industry may support with drug or funding BUT must clearly be intellectual product of the CI Investigator
Industrial :This refers to the Pharmaceutical Industry Design and implementation of the study is controlled by the pharmaceutical company
For National Cooperative Group, Externally Peer Reviewed, Institutional or Industry Sponsored Studies, did a CI Investigator author or co-author this trial (i.e. were they responsible for conceptualizing, designing and/or implementing the trial and reporting the results?
Yes No
If YES, please select the programmatic alignment under NCI Program Affiliation
IF NO, please select non-aligned under NCI Program Affiliation NCI Program Affiliation: select BREAST CANCER ENVIRONMENTAL IMMUNOLOGY NON-ALIGNED STEM-CELL BIOLOGY GROWTH CONTROL GENITOURINARY MELANOMA
Therapeutic Area select ALL ADV. MALIGNANCIES -Ph I/2 BRAIN/NEURO BREAST ENDOCRINE GI GU GYN/ONC HEAD & NECK HEMATOLOGY & TRANSPLANT LABS & TISSUE BANKING LUNG/THORASIC MELANOMA PEDIATRIC PREVENTION/SCREENING/EARLY DETECTION SARCOMAS SUPPORTIVE CARE
Primary Purpose: Choose One of the following:
Diagnostic (DIA): Protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition.
Health Services Research (HSR): protocol designed to evaluate the delivery, processes, management, organization, or financing of health care.
Other (OTH): Not in other categories.
Prevention (PRE): protocol designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition.
Screening (SCR): Protocol designed to assess or examine methods of identifying a condition (or risk factor for a condition) in people who are not yet known to have the condition (or risk factor).
Supportive care (SUP): protocol designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects, or mitigate against a decline in the participant’s health or function. In general, supportive care interventions are not intended to cure a disease.
Basic Science (BAS): protocol designed ot examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention.
Treatment (TRE): Protocol designed to evaluate one or more interventions for treating a disease, syndrome, or condition. Note: (this equates to Therapeutic on previous applications)
Clinical Research Category: Choose One of the following:
Interventional (INT): Clinical Research Category in which individuals are assigned by an investigator based on a protocol to receive specific interventions. The participants may receive diagnostic, therapeutic, behavioral or other types of interventions. The assignment of the intervention may or may not be random. The participants are followed ands biomedical and/or health outcomes are assessed.
Risk to Subjects:select oneGreater than Minimal RiskMinimal Risk
STUDY AGENT
Name/ # of Drug/Biologic
Study Drug use: / select oneAn FDA approved drug for indication and populationA drug for off-label purposeAn investiagional drug polulationAn investigational drugA placeboNo drugs
Study Agent to be provided by: / select one HOSPITAL SPONSOR AT NO CHARGE Other, describe in space provided if you selected other; describe:
RADIOACTIVE MATERIALS
Are radioactive materials being used in this study? selectyesno If yes; specify:
NYU Radiation Safety committee approval attached*selectyesno
Does this trial involve genetic research? selectyesno If yes; specify:
If yes; NYU Bio-safety committee approval attached* selectyesno Recombinant DNA? selectyesno
Biospecimens and Anatomic Pathology
Will pathology materials be submitted to a non-NYUMC facility? / selectYESNON/A
Will non- NYUMC pathology materials be submitted for review? / selectYESNON/A
Will biospecimens be collected, processed, and/or analyzed at NYUMC? / selectYESNON/A
Will biospecimens be shipped from NYUMC to a non NYUMC laboratory? / selectYESNON/A
Will biospecimens be shipped from non-NYUMC sites to a NYUMC laboratory? / selectYESNON/A
Data Reporting Method:Reporting of accrual data is mandated for all cancer related research and therefore must be reported to the NYU Cancer Institute Clinical Trials Office (CTO) via CTMS. The CTMS option will require you to register patients electronically resulting in automatic reporting to the CTO. For access to CTMS and training on patient registration please contact .
Please indicate your data reporting method below:
CTMS CTO Accrual Tracker
I certify that I will report accrual data for this research as mandated by the NYU Cancer Institute and understand failure to do so may result in suspension of enrollment.
PI Signature:Date:
Will you or any sub-investigator participating in this study have, or anticipate having, any non- financial obligations that could constitute a conflict of interest for this study?IF you answered yes above, please explain: / selectyesnoN/A
YOU MUST BE AN INVESTIGATOR LISTED BELOW IN ORDER TO CONSENT A SUBJECT
Name / email / phoneP.I.
Contact
PI Signature ______date ______
List Sub-Investigator (s)
Name / email / phone*Please note: You must be up to date with Human Subjects Training (citiprogram.org) to be added as an investigator on any study, and must remain up to date with your training throughout the course of the study. Continued on next page
Protocol Checklist for Disease management group (DMG) Reviewers
Protocol #
PI: Dr.
Title:
Co-Investigator’s:
DISEASE Management Group (DMG)Reviewer: Committee: Date:
I. General CommentsSEE
Comments / Review guidelines for prmc review
YES / NO / Programmatic Review Criteria
Are the scientific goals clearly defined?
Are the goals realistic?
Are the goals important to the Program?
Are the goals important to the NYUCI?
Is the accrual goal realistic within the stated time frame?
Are there competing protocols? (If so prioritize)
Are there resources (nursing, data management) within the DMG to support this protocol? *
II. Recommended Action
Approve
APPROVE WITH STIPULATIONS
DISAPPROVE / PRIORITY SCORE:
Outstanding (1.0-1.5)
Excellent (1.5-2.0)
Very Good (2.0-2.5)
Good (2.5-3.5)
Acceptable (3.5-5.0)
Protocol Summary(provide at least one paragraph for Industry-sponsored and cooperative group protocols and 1-2 pages for Investigator Initiated Trials):
** Please see next page for DMG Leaders
Name Signature ______DATE:
Disease Management Group Leader
Disease Management Group (DMG) and Discipline Review Co-Leaders
Disease Management Group / Co- LeadersBreast Cancer / Silvia Formenti, MD / Francisco Esteva, PhD, MD
GI / Lawrence Leichman, MD / Elliot Newman, MD
Endocrine / Keith Heller, MD / Kepal Patel, MD
GU / Samir Taneja, MD / Anna Ferrari, MD
GYN / Stephanie Blank, MD / Franco Muggia, MD
Melanoma / Anna Pavlick, DO / Iman Osman, MD
Head and Neck / Mark DeLacure, MD / Nicholas Sanfilippo, MD
Sarcoma / Gerald Rosen, MD / Timothy Rapp, MD
Pediatrics / Linda Granowetter, MD / Sharon Gardner, MD
Hematologic Malignancies / Elizabeth Raetz, MD / Lawrence Gardner, MD
Thoracic Oncology / Harvey Pass, MD / Abraham Chachoua, MD
Neuro-Oncology / Howard Fine, MD / Jeffrey Allen, MD
Phase I Clinical Trials / Anna Pavlick, DO / Franco Muggia, MD
Disciplines Group / Co- Leaders
Supportive Care / Tanveer Mir, MD / Frances Cartwright, PhD
Disciplines
- Epidemiology
- Cancer Economics
- QOL and Cultural Research
Please note: DMG and Discipline Group Co-Leaders may not peer review any study that they are listed as an Investigator.
NYUCI CTO PRMCNew Clinical Trial Application version date September 2012 Page1 of 6