Protocol Review Committee Initial Submission Study Request
Protocol PSCI #
CATS IRB #
Protocol Title
Name of Sponsor
Principal Investigator
Sub-Investigators at Penn State Cancer Institute / Penn State Health Medical Group
Statistician name if IIT
Funding Source
Enter the specific name of the financial sponsor for the project (e.g., NCI, ACS) below. For institutionally sponsored trials or studies (IITs), list the names of the applicable funding agencies.
Research Coordinator/Primary Contact
Primary Disease-Specific Team leading the study
Other Disease Specific Teams that may accrue to this study
Site(s) where the study is to be open
Hershey Medical Center
College of Medicine
St. Joseph Medical Center
Andrews Patel
Does this protocol involve cancer?
Yes
No
Does this protocol involve only the analysis of pre-existing data?
Yes
No
Does this protocol entail intervention (therapeutic or non-therapeutic) in current patients?
Yes
No
Study Source
National:
NCI National Clinical Trials Network (NCTN) and other NIH-supported National Trial Networks.
Externally Peer-Reviewed:
R01s, SPORES, U01s, U10s, P01s, CTEP, or any other clinical research study mechanism supported by the NIH or organizations on this list: Peer Review Funding Orgs
Institutional:
In-house clinical research studies authored or co-authored by PSCI investigators and undergoing scientific peer review solely by the Protocol Review and Monitoring System of the PSCI. The PSCI investigator has primary responsibility for conceptualizing, designing, and implementing the clinical research study and reporting results. 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. This category may also include Institutional studies authored and implemented by investigators at another Center in which PSCI is participating; Multi-Institutional studies authored and implemented by investigators at PSCI (Note: National and externally peer-reviewed studies should be listed with those categories, not as Institutional studies).
Industrial:
A pharmaceutical company controls the design and implementation of these clinical research studies.
Externally Peer-Reviewed by:
Clinical Research Category
Interventional:
Individuals are assigned prospectively by an investigator based on a protocol to receive specific interventions. The participants may receive diagnostic, treatment, behavioral, or other types of interventions. The assignment of the intervention may or may not be random. The participants are followed and biomedical and/or health outcomes are assessed.
Observational:
Studies that focus on cancer patients and healthy populations and involve no prospective intervention or alteration in the status of the participants. Biomedical and/or health outcome(s) are assessed in pre-defined groups of participants. The participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator of the observational study is not responsible for assigning specific interventions to the participants of the study.
Ancillary or Correlative: Ancillary:
Studies that are stimulated by, but are not a required part of, a main clinical trial/study, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies must be linked to an active clinical research study and should include only patients accrued to that clinical research study. Only studies that can be linked to individual patient or participant data should be reported.
Correlative:
Laboratory-based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc. Only studies that can be linked to individual patient or participant data should be reported.
If Ancillary, parent/main protocol is PSCI #:
Primary Purpose
Basic Science (BAS):
Protocol designed to examine the basic mechanisms of action (e.g., physiology, biomechanics) of an intervention.
Device Feasibility (DEV):
An intervention of a device product is being evaluated in a small clinical trial (generally fewer than 10 participants) to determine the feasibility of the product; or a clinical trial to test a prototype device for feasibility and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial.
Diagnostic (DIA):
Protocol designed to evaluate one of 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.
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.
Treatment (TRE):
Protocol designed to evaluate one or more interventions for treating a disease, syndrome, or condition. Note: This equates to therapeutic trials in previous versions of the guidelines.
Other (OTH):
Not in other categories
Study Summary: Are there competing trials?
Yes
No
If yes, please provide the rationale for considering this trial. Will this replace an existing trial, or will the competing trial be closed
Primary Objectives:
Secondary Objectives:
Disease Information
Disease:
Stage:
Anatomic Site
The anatomic cancer site(s) (e.g., breast, ovary), the clinical research study focuses on. If the clinical research study is broadly applicable to a number of potential anatomic sites, enter the term “multiple”
Does the study involve a rare tumor according to the NCI definition, pediatric malignancy or molecularly targeted therapy?
Yes
No
Describe the rare tumor, pediatric malignancy or molecularly targeted therapy
In multi-modality trials and multi-disease site trials, have representatives of each involved modality (e.g., medical oncology, radiation oncology, surgical oncology, and others as indicated) and each Disease Specific Team been involved in the review of this study and agreement with its proceeding?
Yes
No
N/A
Is Radiation used (i.e. RT review needed)?
Yes
No
Use or manipulate a biological product (i.e. IBC review)?
Yes
No
Disease Team Approval
Yes
No
N/A, study is non-interventional, non-treatment, and not being run by PSCI CTO
Protocol Status
How long has the Sponsor had this protocol open to accrual?
If open to accrual, identify the current accrual status:
Target Accrual
Current Accrual
Not Yet Open to Accrual
Estimated duration for participant (years):
Is this a multi-phase trial?
Yes
No
What Phase will PSH/PSHMG participate in?
Accrual Projections at Investigators site
Study Overall Accrual Expected
PSCI/PSHMG Annual Projected Accrual
PSCI/PSHMG Accrual Timeline (# of years)
PSCI/PSHMG Total Project Accrual (Annual Accrual * # of years to accrue at PSH/PSHMG):
Is the funding adequate to cover all projected expenses of this study?
Yes
No
To be assessed by the College of Medicine
Feasibility. Has a protocol feasibility assessment been completed?
Yes
No
Data Safety Monitoring Plan: The Data Safety Monitoring Plan is on page(s):
What entity will be responsible for monitoring the data and safety?
PSCI DSMC
External DSMB
Other
N/A, study is non-interventional
Entity responsible for monitoring the data and safety
Disease Team Approval Form
Preliminary Feasibility Form
PI Feasibility Form
Priority Tree
Disease Team Meeting Minutes (showing the vote)
Protocol
Data and Safety Monitoring Charter
Additional document
Name of the person submitting this form
Email of the person submitting this form