CRPC Submission form Completion Instructions
Roswell Park Cancer Institute
Clinical Research Prioritization & Feasibility Committee (CRPC) V 15 12-28-12

GENERAL INFORMATION:

  1. CRS personnel do not support submission into CRPC and have been instructed to refer submission requests to Julie Haney at ext 3340 or pager 541-6900 pin 4268.
  2. i2 Links are only accessible to RPCI appointed faculty and staff with intranet access granted.
  3. CRPC Deadline: Submission requests should be received 3 full working days prior to the meeting. (Wednesday prior to Tuesday meeting 4pm) The committee meets the first and third Tuesday of each month. Deadlines and meeting dates can be accessed through the internal CRS i2 links:

2012: https://i2.roswellpark.org/#/files/listing/c52510f3-2c0a-430e-9642-c34b74a213ae

2013: https://i2.roswellpark.org/#/files/listing/d995ca4d-7589-4193-8a85-20476e7a9e7f

  1. Document/Form access: The following documentation is required to be submitted by the PI or listed Co-I into the outlook group email titled:
  1. Current CRPC forms can be found on the following external website:

https://i2.roswellpark.org/#/blocks/listing/5be3987e-4ccc-4942-aff9-bf96a6f29f9b

  1. Required submission documents include the following:
  1. CRPC completed submission form (current version must be used)
  2. Priority Scoring Sheet with PI scoring column completed (Intervention studies only- current version posted must be used)
  3. Protocol (draft will be accepted) or study synopsis- can detail synopsis within the submission form itself
  4. DSRG written approval documentation as provided by each DSRG (Email documentation is acceptable) Please consult with the appropriate DSRG leader and see DSRG guideline link: https://i2.roswellpark.org/#/files/listing/a800636c-1524-42c1-887d-f711cb2ceab7
  1. CRPC approval: Good for a period of one full year from the meeting date of approval
  2. All Intervention studies must be submitted and presented by the PI or a listed Co-I to the Clinical Research Prioritization and Feasibility Committee (CRPC).
  3. Approval is required in order to submit a study into the Scientific Review Committee (SRC).
  4. Non-Intervention studies must also be submitted into CRPC if:
  1. Administrative approval is being sought (no RPCI resources outside of the PI department is used to implement the study) submit all required documents for review at the next available meeting- PI/Co-I will not need to present at a full committee meeting
  2. RPCI resources outside of the PI department are being utilized to implement the study (ie Pathology, approved bank, CRS CRC etc.) - full board submission and presentation is required.
  3. If Tissue is being requested, the study must be submitted and presented by an Investigator to the committee.
  1. SRC deadline: A detailed yearly calendar is posted on the internal RPCI CRS and IRB web site. New studies are accepted daily, but will be batched and reviewed per the submission calendar.

Studies that qualify for Full Committee submission and review include:

  1. PH sponsored or collaborative PH studies
  2. Pure Investigator Initiated if not externally peer reviewed

Studies that qualify for Executive Committee submission and review include

  1. NCI Cooperative Group studies (Alliance, CTSU, GOG, RTOG, COG, etc)
  2. Non-Intervention studies
  3. Externally peer reviewed studies

a.  R01s, SPORES, U01s, U10s, P01s, CTEP, or any other clinical research study mechanism supported by the NIH or an approved peer-reviewed funding organization

  1. Phase I core program reviewed protocols (I or Collaborative PH)
  1. SRC approval must occur before submission into the Office of Research Subjects Protection (ORSP) for Institutional Review Board (IRB) consideration.
INSTRUCTIONS

INTRODUCTION:

1.  Check the appropriate box for CRPC or SRC submission (CRPC submission must occur prior to SRC submission- the same form is utilized for both submissions).

2.  Enter in the date of submission.

3.  Enter the Principal Investigator name (only one Principal Investigator can be identified) other Investigators can be listed including any considered to be the Grant PI.

SECTION A: GENERAL INFORMATION

Study Title: The study title must match the FINAL protocol document (This might change from the time of concept approval at CRPC and SRC submission) Any changes in title should be given to the Submission group for database updating. Sponsor or cooperative group study numbers should be referenced in parenthesis prior to the title. (i.e. (CALGB 02201) ; A randomized phase II study of …) Please use exact title as it appears on the protocol title page.

Type of study:

Please check Intervention or, Non-Intervention- for questions, please contact the submission office at the outlook group email:

FYI: Existing Data Reviews EDR: Retrospective Chart reviews-

·  Not required to use this form or obtain CRPC approval.

Please direct inquiries to Julie Haney or Virginia Doran for EDR submission support.

SECTION B: STUDY TEAM

Complete the list of study contacts:

·  PI: Principal Investigator: Only one principal investigator can be identified for each site participating. For Intervention studies the PI must be an MD with the exception of normal healthy patient populations. If there are multiple PI’s listed on a grant application, one Investigator can be added as a Grant PI within the CRS database.

·  Statistician Co-Investigator: Required for all RPCI written (RPCI will be housing and analyzing the data) Investigator Initiated studies prior to SRC submission.

o  Statisticians must be listed as Co-Investigators on these types of studies. Stat Verification form (submission sign off) is required if RPCI Biostatistician will be involved in the data analysis. (as indicated in section C- item F)

o  If RPCI is partnering with Industry and the data will not be housed or analyzed by the RPCI Biostatistician, they do not have be listed as a Co-I.

·  Co-Investigator: Multiple Co-Investigators can be listed IF they are closely associated with the design and conduct of the study. Only MD Investigators can consent to Intervention studies. At least one MD Co-I is required on Intervention studies to ensure there is coverage in times of PI absence. Please note (if the study includes Radiation, Pathology or a Radiology component, applicable Co-Investigators from those areas should be consulted and added)

·  Additional Consenter: Individual that is solely assigned by the Principal Investigator to consent subjects but is not a listed Co-Investigator on the study

·  Department Data Manager: Non-CRS staff who will view/access medial record data (PHI) and/or record identifiable data for the study.

PLEASE NOTE: All persons listed must have completed the RPCI CITI group Human Subjects protection AND Responsible Conduct in Research module training if submitting for RPCI IRB approval. Students may be allowed to use school IRB approval but will need to show applicable Human Subjects Protection training.

All MD Investigators must also have a current NCI Investigator number. Please ensure completion PRIOR to submission into SRC. Regulatory Associates within CRS can verify current certification dates by:

  1. Opening up any study in the CRS DB
  2. Click on the delegation tab
  3. Click on the Certification tab

Investigators and personnel with certification and NCI number assignment will appear in alphabetical order. A notification letter has been developed and is housed in the RRA common helpful document folder to send to Investigators who need to complete the required training.


SECTION C: STUDY INFORMATION:

NCI Classification: Check only one- these are defined per the RPCI Cancer Center Support Grant.

1.  I: Institutional:

a.  In-house clinical research studies authored or co-authored by Cancer Center investigators and undergoing scientific peer-review solely by the Protocol Review and Monitoring System of the Cancer Center.

b.  The Cancer Center investigator has primary responsibility for conceptualizing, designing and implementing the clinical research study and reporting results

c.  It is acceptable for industry and other entities to provide support (e.g., drug, device, other funding) but the trial should clearly be the intellectual product of the center investigator.

d.  This category may also include:

§ Institutional studies authored and implemented by investigators at another Center

§ Multi-site institutional studies authored and implemented by investigators at your Center

(Complete boxes A-F regarding sponsor relations, data management etc)

2.  PH: Pharmaceutical:

The design and implementation of these clinical research studies is controlled by the pharmaceutical company

a.  If an RPCI Investigator collaborated in the conceptualization and design of the study, please check yes

3.  NCG: National Cooperative Group: The study is developed by a National Cooperative Group. (i.e. ALLIANCE, COG, GOG, RTOG etc) (Complete box A regarding input into study design/development only)

4.  STHD StudentThesis/Dissertation: Study written and facilitated by a master’s student. The purpose of this study is solely for the completion of their program.

  1. Must have a faculty MD PI for Intervention studies.
  2. Schools affiliated through contracts with RPCI can be considered for acceptance of IRB approvals from the school.
  3. Please contact Julie Haney at 716-845-3340 for more information.

(Complete box G regarding IRB of record)

  1. Did the PI/site team contribute to the design and development of study- If yes, you are confirming that the study was distributed for input prior to it being finalized for study submission. This can be the case for studies written with cooperative groups, industry or solely written at RPCI. Answer yes or no
  2. Is the study conducted through a formal consortium- If you are answering yes to this question, you are indicating that there is a formal contract agreement in place between the consortium and RPCI. (ie NO1 through OSU, PCCTC, ACCRU)
  3. Check yes or no and provide Name of Consortium.
  4. Provide name of the coordinating site where RPCI will need to obtain/communicate with for Regulatory Documents
  5. Will CRS be responsible for data management- This question primarily refers to building the CRS electronic data capture system? Currently only Clinical Intervention studies are supported by the CRS data system. Non-Intervention studies typically are managed by the PI department personnel or Investigators. Special requests for Non-Intervention data builds can be forwarded to the AVP of Clinical Research Services.

·  Answer yes or no for Intervention studies

·  Answer where the study data will be housed if non-intervention

  1. Will CRS personnel be responsible for Data Monitoring?

·  For partnered studies where the data is housed at a cooperative group or Pharmaceutical sponsor company- indicate “no” and answer who will be responsible for data monitoring (e.g.CRO/Sponsor).

·  CRS supports data monitoring per the Institute Data Safety Monitoring Plan for all Intervention studies built in the CRS electronic data capture system per “C” above- Indicate yes

  1. Is there potential for Rochester General Hospital, a RPCI research satellite to participate in this study. If yes, please contact the CRS Network Director; Mary Eileen McPhee ext 1203 to discuss
  2. Will the RPCI Biostatisticians be involved in the analysis of this study- answer yes or no
  3. For Student study submissions only: Will RPCI be the IRB of record? Check Yes if true, check No and fill in who will be responsible IRB. RPCI IRB must have an affiliation agreement in place with the named IRB. This will be verified prior to submission into SRC.

Role of RPCI Investigator: Check one box:

·  RPCI site PI

·  RPCI site PI and a Registered Nurse (i.e. RN, BSN, NP etc)

·  National/Multi site PI- please provide details on the number and location of sites that are being coordinated.

NCI Program Designation- Current available Cancer Center Support Grant developed programs are listed. One primary program must be selected. Please ensure that the program selection is identified and verified by the Principal Investigator submitting the study. If unsure of program designation, please check with Department Chair/Head. Designation is verified by the AVP, CRS during SRC review.

Study type[((]*- Identify the appropriate study phase/type by checking the appropriate box.

Pilot- First study of its type. An innovative new study with a new approach.

Phase I- Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects

Phase I/II- A study that will begin as a phase I to identify the maximum tolerated dose, then continue in the phase II portion.

Phase II- The experimental study drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III- The experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

Phase IV- Post marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.

Other-Types of studies that may not indicated above.

Clinical Program: Please verify clinical program with the Principal Investigator. OTH classification is indicated for Prevention studies.

RPCI Translational Research Component Investigator: Should also be listed as a Co-Investigator in Section B. If this investigator is the PI of the grant, please indicate this in this section.

RPCI Translational Research Component: Please list the RPCI translational research component supporting this study. Detail the science based work completed at RPCI translating into the clinical phases.

Intervention Plan: This can be the study synopsis or draft protocol at CRPC but should be changed to indicate “see attached protocol”

Objectives of study: This can be in the study synopsis or draft protocol at CRPC but should be changes to indicate “see attached protocol”

Brief Summary of scientific rationale: This can be a study synopsis or draft protocol at CRPC but should be changed to indicate “see attached protocol ”

Brief Statistical plan: This can be a study synopsis or draft protocol at CRPC but should be changed to indicate “see attached protocol”

National Target- If applicable.

·  Identify the number of participants needed on a national or multi-center level.

·  The number of participants that will be recruited to complete the study. This number includes dropouts. It does not include screen failures

RPCI Target- If the trial is investigator initiated or industry sponsored, indicate the RPCI expected target. This target will not be needed for cooperative groups.

Duration of enrollment – This is the expected time for accrual/enrollment to be completed, which is required to be listed for all studies.

Duration at other sites: If multi-institutional, please list national activation date and current national accrual to date.

Source of funding: Please list sponsor name, or grant name/type along with date of submission. CRS will provide a budget for all intervention studies, state alternative plan if grant is not approved.