Revised June 16, 2021
In competing applications (Types 1 and 2), the Data Tables (DT) facilitate consistency and thoroughness in review by providing peer reviewers with standardized information on center organization and leadership, active cancer-related research, and several aspects of clinical function.
In non-competitive applications (Types 3 and 5), electronic DT 1-4 (eData), submitted to the Office of Cancer Centers (OCC), are used to assess center progress, generate reports, and produce benchmark data on the Centers program.
Please use the following table to determine appropriate DT submission:
|Application Type||ASSIST||RPPR||eData (to OCC)|
|1||DT 1-5||None||None (DT 1-4 due if CCSG is awarded)|
|2||DT 1-5||None||DT 1-4 (60 days prior to start date)*|
|3||NA||DT 1||DT 1-4 (60 days prior to start date)|
|5||NA||DT 1||DT 1-4 (60 days prior to start date)|
Note: Per NIH policy, T2 applications serve as the progress report for the fiscal year in which the application is newly funded. Although no separate RPPR need be submitted 60 days prior to the start date of the newly funded award, DT 1-4 must still be submitted at that time.
See eData Guide for instructions on format.
General Instructions for DTs:
DT 1A-D provide general information about the Senior Leadership, Research Programs, Cancer Center Membership, and Shared Resources.
For T2 applications, “New” in DT 1 refers to new since the last T2 application. For T3 and T5, “New” refers to new since the last T3 or T5 progress report.
For a center-defined reporting date, follow the format below to report the Senior Leadership:
|Name of Senior Leader||Title of Leader||Degree(s)||New Leader?|
|Sutton, Baylor||Director and Principal Investigator||MD, PhD|
|Marucco, Gina||Deputy Director||PhD|
|Galley, Mark||Assoc. Director for Basic Science||MD||Yes|
|Barrie, Thomas||Assoc. Director for Clinical Research||MD, PhD|
|Wong, Lee||Assoc. Director for Population Research||PhD|
For a center-defined reporting date, define a center-selected alphanumeric code to denote each Research Program, and follow the format below to report the Research Programs:
|Program Code||Program Name||Program Leaders||Degree(s)||New Leader?||New Program?||Members|
|01||Molecular and Cellular Biology||Harrington, Marc
|02||Cancer Control and Prevention||Pham, Phuong||PhD||Yes||Yes||14|
|WC||Women’s Cancers||Miller, Barbara||PhD||22|
|CCGC||Cell Cycle and Growth Control||Neuhauser, Beverly||MD||12|
Note: Include Program Leaders in number of members. Members in more than one program should be counted once.
For a center-defined reporting date, follow the format below to report the Shared Resources:
|Name of Shared Resource||Resource Director(s)||Degree(s)||New Leader?||New Resource?||Developing Resource?||Category|
|DNA Microarray||Poole, Bruce||MD||Yes||1.35|
|DNA Sequencing||Kelley, Mark||MD, PhD||1.22|
|Genomics and Proteomics||Goldstein, Phillip||MD||Yes||1.36|
|Vaccine Core||Mark, Joseph||PhD||1.37|
|Organic Synthesis||Singer, Richard||PhD||Yes||1.12|
|Transgenic Animals||Peters, Douglas
|1.03, 1.06, 1.09|
|Translational Chemistry||Hahn, Otto||PhD||Yes||4.08|
DT 2A and 2B report all active cancer-related research grants and contracts held by center members and awarded by external sources to the fiscally responsible institution of which the Cancer Center is a part. Grants and contracts to center members awarded to other institutions that are not formal consortium partners of the center should not be included.
Provide the following information:
PI: The last name and first initial of the PI from your Center responsible for this project (e.g., Alfred L).
Specific Funding Source: The specific name of the financial sponsor for the project (e.g., NCI, ACS).
Project Number: Use the application or grant number. This unique identification number for NIH grants, for example, is composed of the type code, activity code, Institute code, serial number, support year, and/or suffix code (e.g., 1R01CA059736-01).
Project Start Date: Official date a grant award begins; same as the first day of the first budget period.
Project End Date: Official date a grant award ends; same as the last day of the final budget period.
Project Title: The official title of the research project being carried out (e.g., Regulation of mitochondrial inheritance in yeast); please be as complete as possible.
Annual Project Direct Costs: Annual funding awarded for a particular project.
Cancer-relevant Annual Project Direct Cost: Estimate, using a method of the Centers devising, the cancer relevant portion of a project and report the funding. Be prepared to defend this estimate in peer-review. For grants that are 100% cancer-relevant (such as all NCI grants), this will be identical with the Annual Project Direct Costs.
Program Code: Provide the code of the Program, as defined by the Center in DT1B, with which this grant is associated. A single grant or contract may be associated with multiple programs. Any grant or contract that is infrastructure-related (such as the CCSG and its supplements, cores associated with such projects as SPOREs or P01s) should be coded ZY.
Percent: The portion of the funding associated with a Program.
Annual Program Direct Cost: The portion of direct cost funding associated with the indicated Program.
The following examples are illustrated in the table
Note: Do not number the rows- that is for illustration purposes in this example table.
DT 2B describes the total number of cancer-related research projects (excluding the CCSG itself and associated supplements) and their aggregate total annual direct cost.
Follow the example below:
|Specific Funding Source||Project Direct Cost||Total Number of Projects|
|NCI Peer-Reviewed Projects||$5,180,000||13|
|Other NIH Peer-Reviewed Projects||$1,916,000||9|
|Other Peer-Reviewed Projects||$2,377,000||5|
|Subtotal Of Peer Reviewed Projects||$9,473,000||27|
|Industry Non-Peer-Reviewed Projects||$325,000||2|
|Other Non-Peer-Reviewed Projects||$1,313,000||4|
|Subtotal Of Non-Peer Reviewed Projects||$1,638,000||6|
|Grand Total (All Projects)||$11,111,000||33|
DT 3 is intended to provide reviewers with an overview, organized by primary anatomic cancer site, of the number of cancer cases seen at the Cancer Center.
For a center-defined 12-month reporting period, DT 3 therefore reports the number of newly registered patients at the Cancer Center (registry analytic and non-analytic cases, as defined below.
Use the following definitions to complete the DT 3 table:
Do not include:
A Cancer Center without access to a local or institutional registry should use alternate means to capture data as close as possible to the above definition.
Follow this table to determine method of reporting Newly Registered Patients:
|Source of Patients||DT3 “Newly Registered Patients”|
|Cancer Center primary clinical arm(s), e.g., adult and pediatric hospitals and outpatient clinics that report through the Center’s cancer||Include|
|Center primary clinical arm(s) that report through a separate cancer registry||Include as separate DT3|
|CCSG peer-reviewed and NCI approved consortium partner hospital or clinic that reports through the Center’s registry||Include in same DT3|
|CCSG peer-reviewed and approved consortium partner’s hospital or clinic that reports patients through another registry||Include as separate DT3|
|Cancer Center affiliates that do not report through the center’s registry||Exclude|
DT 4 serves as a report of the cancer-related hypothesis-driven clinical research studies open at the Cancer Center during a center-defined 12-month reporting period. Consortium centers submit only one DT4. Use the following definitions to complete DT 4:
Accrual: An accrued subject or enrolled participant is defined by "a participant's, or their legally authorized representative’s, agreement to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for the study, but do not participate in the study, are not considered enrolled unless otherwise specified by the protocol” per ClinicalTrials.gov Protocol Registration Data Element Definitions for Interventional and Observational Studies.
Multi-Institutional Clinical Research Study: Clinical Research Studies that recruit participants from two or more geographically distinct enrollment Institutions not affiliated with your cancer center (e.g., other NCI-designated Cancer Centers or other research institutions). The Institutions are usually distinct in other characteristics (e.g., demographic, socioeconomic, or clinical).
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:
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: Organizations with Peer Review Funding Systems.
Institutional: 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. The Cancer Center investigator has primary responsibility for conceptualizing, designing, and implementing the clinical research study and reporting results.
Industrial: A pharmaceutical company controls the design and implementation of these clinical research studies.
Sort the data by Clinical Research Category and Study Source:
INTERVENTIONAL Externally Peer-Reviewed;
OBSERVATIONAL Externally Peer-Reviewed, etc.,
ANCILLARY/CORRELATIVE Externally Peer-Reviewed, etc.
Report the table alphabetically by PI.
The column headings are defined below:
Specific Funding Source: The specific name of the financial sponsor for the clinical research study. For institutionally sponsored trials or studies, list the name of the applicable funding agencies.
Primary Site: The primary cancer site(s) (i.e. breast, ovary) the clinical research study focuses on. If the clinical research study is broadly applicable to a number of potential primary sites, enter the term “multiple” in this column. Refer to ICD 10 for a list of Primary Disease Sites.
Protocol ID/IRB Number (Proto ID): Provide the unique identifier for this study. Where available, list the NCT number, as well as the common protocol number that the trial is known under nationally, if one exists. For other trials that do not have an NCT number or a common protocol number that the trial is known under nationally, use an internal protocol identification or IRB number.
NCT ID:The unique ID assigned to the trial by the National Clinical Trial program (ClinicalTrials.gov) for trials that have been submitted to ClinicalTrials.gov Protocol Registration System (PRS) previously. This ClinicalTrials.gov ID appears as "NCT" followed by 8 numeric characters (such as NCT12345678). (i.e., NCT00009876); If it is not applicable, use the ProtocolID.
Protocol ID/IRB Number (Proto ID): The unique identifier for the study. List the common protocol number that the trial is known under nationally, if one exists. For other trials that do not have an NCT number or a common protocol number that the trial is known under nationally, use an internal protocol identification or IRB number.
Other Protocol ID (Other Proto ID): Additional IDs assigned to the trial, including the following: NCI, Cancer Therapy Evaluation Program (CTEP) or Division of Cancer Prevention (DCP), unique IDs from other registries, Protocol numbers assigned by the review board, other IDs.
Local Trial ID: The unique ID assigned at the Cancer Center level and used at the sites level to identify a trial.
NCI ID: The unique ID assigned to the trial by the NCI's Clinical Trials Reporting Program (CTRP).
PI:The last name and first initial of the PI from the Center who is responsible for this Clinical Research Study.
Program (Prog) Code: Use the Research Program code defined by the center in DT 1B. For clinical research studies that span more than one Research Program, include both Program Codes in this column.
Date Opened (activation): The official start date of a trial determined by 1) the date of activation noted in an official clinical trial activation announcement or 2) date of first patient accrual if the trial in question did not have a formal activation announcement.
Date Closed: The date the clinical research study closed to accrual. This does not include patient follow-up. If the study is still open, leave this field blank.
Early Phase I: Exploratory trials, involving very limited human exposure, with no therapeutic. or diagnostic intent (e.g., screening studies, microdose studies). See FDA guidance on exploratory IND studies for more information.
I:Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
I/II:Trials that are a combination of phases 1 and 2.
II:Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
II/III:Trials that are a combination of phases 2 and 3.
III:Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug.
IV:Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.
N/A:Trials without phases (for example, studies of devices or behavioral interventions).
Pilot:Pilot attribute can be assigned to any phase. Indicate whether the study is a pilot phase by inserting “Yes” to the “Pilot” column.
Assign the appropriate Primary Purpose to Interventional or Non-Interventional (Observational or Ancillary/Correlative) Clinical Research Categories.
Basic Science (BAS): Protocol designed to examine the basic mechanisms of action (e.g., physiology, biomechanics) of an intervention.
Device Feasibility (DEV): Protocol designed to evaluate one or more interventions for the feasibility of the product or to test a prototype device 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
Official Title: Official name of the protocol provided by the study PI or sponsor (Limit: 8000 characters or fewer).
Multi-institutional Clinical Research Study: Indicate if the trial is multi-institutional by inserting ‘Yes’ in the “Multi-inst study” column (see definition above).
Total Targeted Accrual:For both single-institution and multi-institutional trials initiated at your Center, indicate the total number of participants needed for the entire study. For multi-Institutional trials that your Center participates in but did not initiate, leave “Entire study” column empty. Do not submit a targeted range, such as “10 – 100.”
Targeted Accrual for your Center:For single-institution and multi-institutional trials initiated at your Center, indicate the total number of participants your Center is expected to accrue for the study. For single-institution trials the “Total Accrual for your Center” and the “Total Targeted Accrual” numbers will be the same. Do not submit a targeted range, such as “10 – 100.”
Entire Study Acrrual to Date:
DT 5 reports the Cancer Center’s current budget (Type 2) and its requested budget (Types 1 and 2).
|CCSG Budget Category||
Current Budget (direct costs)*
MM/DD/YY – MM/DD/YY
(Last full year of the current project period)
Requested Budget (direct costs)
MM/DD/YY – MM/DD/YY
(First full year of the new project period)
|Program Leaders (salary)|
|Research Program (non-salary)|
|Program 2, etc.|
|Leadership, Planning & Evaluation|
|Senior Leadership (salary)|
|Developmental funds (exclude "Developing New Shared Resources" category)|
|Operating costs / Activities|
|Devloping New Shared Resources|
|Clinical Protocol and Data Management|
|Protocol Review and Monitoring System (PRMS)|
|Community Outreach and Engagement|
|Cancer Research Training and Education Coordination|
|Total Direct Costs|
Note: DT 5 includes third party indirect costs. It does not include CCSG carryover funds or CCSG supplement dollars.
Cover Page, Footnote
|Modified v3.1 to v3.1.1
Modfied Table Structure
Modified the following categories:
|08/29/2018||DT4||Per request from the Cancer Centers, two new fields were added: Entire Study Accrual to Date and PS Open Date.|
|02/14/2018||DT3||Modified the definition of the Accural.|
|DT4||To further harmonize fields and definitions with the ClinincalTrials.gov and CTRP: Renamed NCT Number to NCT ID and modified the definition, modified Phase, modified the definition of the Protocol ID, and Other Institutions, added “Dev” option to the Primary Purpose, added Pilot, Other Protocol ID, NCI ID, and Local Trial ID fields, removed the Mapping of Previous Study Type and New Primary Purpose Designations and Mapping of Previous and Newly Defined Clinical Research Categories tables.|
|01/24/2017||DT3||Combined “Female Breast” and “Male Breast” into “Breast”|
|12/22/2016||DT1||Eliminated 1C – Program Members; added total members to bottom of 1B; 1D is now labeled 1C|
|DT2||Eliminated total costs|
|DT2||Added total project funding for each grant and cancer-relevant funding|
|DT2A and DT2B||Moved all training projects to Cancer Research Career Enhancement and Related Activities|
|DT3||Eliminated “Patients newly accrued to treatment trials”|
|DT4||No changes – CTRP will generate DT4 in the future (2018 or later)|
|DT5||Minor format changes. Although not specifically called for in the FOA (at NIH’s insistence), we recommend Centers continue to report both previous and proposed CCSG funding, and new Centers (Type 1) report proposed CCSG funding|
|DT3 and DT4||Changed Anatomic Site to Primary Site|