The following table responds to some frequently-asked questions about the CTRP Data Table 4 report:
| ID | Category | Question | Answer |
|---|---|---|---|
| 1 | CCSG Data Table 4 Specification | Where can I find the NCI Office of Cancer Centers (OCC) P30 Cancer Center Support Grant Data Table 4 specification? | Refer to https://cancercenters.cancer.gov/GrantsFunding/eData#dt4. |
| 2 | CTRP Data Table 4 Data Elements | Where can I find descriptions of the Data Table 4 data elements as generated in CTRP? | Refer to Data Elements Included in the CTRP Data Table 4 Report. |
| 3 | CTRP Data Refresh (DWH) | If I make data updates in CTRP Registration and/or Accrual, when can I expect to see this information on my CTRP DT4 report? | The data needs to refresh in the data warehouse overnight; therefore, it will not show up on your CTRP DT4 report until the next day. |
| 4 | CCSG Data Table 4 Specification | What is the definition of an interventional trial? | The definition used by the CTRP team for an interventional trial is: https://prsinfo.clinicaltrials.gov/definitions.html Interventional (clinical trial): Participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes. https://cancercenters.cancer.gov/Documents/CCSGDataGuide508.pdf 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. |
| 5 | CTRP Data Table 4 Data Elements | Does CTRP support registration of non-interventional studies (observational and ancillary-correlative)? | CTRP currently accepts, but does not require, data on observational trials and ancillary correlative studies. |
| 6 | CTRP Data Refresh (DWH) | Can we use CTRP Data Table 4 for both interventional trials or non-interventional trials? | CTRP supports the ability to generate both a CTRP Data Table 4 report for interventional and non-interventional trials; however, only interventional trials are currently mandated for non-competing applications. |
| 7 | CTRP Data Table 4 - Interventional Trials | When will CTRP-generated Data Table 4 (interventional trials) be used for Competing applications? | NCI plans to transition to CTRP DT4 for interventional trials for competing CCSG applications in FY20 (September 25, 2019). |
| 8 | Scope of Trials on the Report | What specific statuses does CTRP use to define open trials which should appear on our Data Table 4 for a specific reporting period? | Refer to the following pages: |
| 9 | Scope of Trials on the Report | If a trial/site has a status of Temporarily Closed for the entire reporting period, does CTRP include it on our Data Table 4 report? | Yes. |
| 10 | Scope of Trials on the Report | Does the CTRP Data Table 4 report include the date that a trial closed even if the date is after the reporting period? | Yes, the CTRP Data Table 4 report includes “Date Closed” even if the date is after the reporting period. |
| 11 | Scope of Trials on the Report | Our participating site is "Open" during the reporting period but does not appear on our Data Table 4 report. Why could this be the case? | If the Overall Trial Status reached a Closed to Accrual and/or Closed to Accrual and Intervention status prior to the reporting period, that Overall Trial Status takes precedence over what the participating site has as their status. The Data Table 4 report includes only those trials that meet all of the criteria listed in the Types of Trials Included in the CTRP Data Table 4 Report page. |
| 12 | Lead Organization "Responsible Party" Multi-Site Trials: Source of Data | Who reports trial status for all participating sites? | The lead organization reports trial status and accrual data for all participating sites.
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| 13 | Non-Cancer Trials | How should we represent non-cancer trials (such as a bone marrow transplant trial) in CTRP and for Data Table 4 reporting? | You can register non-Cancer trials in CTRP but exclude them from the CTRP Data Table 4 report. If you have a non-cancer trial registered in CTRP, send a message to the CTRO (NCICTRO@mail.nih.gov) and request that this trial be excluded from your Data Table 4 report. |
| 14 | Expanded Access Trials | Should we include Expanded Access studies on the Data Table 4 report? | It is up to the discretion of each Cancer Center in regards to whether or not you would like to include Expanded Access studies on your CTRP DT4 report. If you have an Expanded Access trial registered in CTRP that you would like to exclude from your CTRP Data Table 4 report, send a message to the CTRO (NCICTRO@mail.nih.gov) and request that this trial be excluded from your Data Table 4 report. |
| 15 | Healthy Volunteers | Should we count healthy volunteers aligned to an interventional trial for Data Table 4 reporting accrual? | Yes, but exclude donors. |
| 16 | Veterans Administration (VA) Trials | Should we register VA trials in CTRP and count them for Data Table 4 reporting? | It is up to the discretion of the center. You could count VA accrual in the “Center” column, in the “Other” column, or not at all for a given Center’s CTRP generated Data Table 4 for both interventional and non-interventional trials. A majority of Centers are including these trials as Affiliations in their CTRP Family so that accrual data shows up in the “Other” columns. |
| 17 | Managing Data Table 4 Information for Your Center | How do we add site/center-specific information associated with Data Table 4 fields to CTRP? | You can add this information at the following “Managing Data Tabl4 Information for your Center section in Registration. |
| 18 | Managing Data Table 4 Information for Your Center: Program Codes | How do we add program code data in CTRP? | You can update program codes at the participating site level in CTRP Registration. For instructions, refer to Managing Program Codes. You can also request a copy of the template to batch load your program code data from your local CTMS into CTRP. To make that request, send a message to the CTRP Technical Support at CTRP_Support@nih.gov. |
| 19 | Managing Data Table 4 Information for Your Center: Your Center Total (Target Accrual) | How do we add target accrual data for our center in CTRP? | You can update target accrual ("Your Center Total" on the Data Table 4 report) at the participating site level in CTRP Registration. For instructions, refer to Managing Targeted Accrual. You can also request a copy of the template to batch load your target accrual data from your local CTMS into CTRP. To make that request, send a message to the CTRP Technical Support at CTRP_Support@nih.gov. |
| 20 | National Trials: Source of Data | How can I update the data in CTRP for National trials? | We take this data (all of the sites) directly from the Cancer Trials Support Unit (CTSU). For more information, send a message to ctsucontact@westat.com. |
| 21 | Multi-Site Trials: Source of Data | Can I enter my center-level Local Trial ID data in CTRP? This would help with mapping and general search purposes. | Yes, if you represent the lead organization for a trial, CTRP allows you to enter your Local Trial ID in the optional Other Trial Identifier field during trial registration. You can also request a copy of the template to batch load your Local Trial ID data from your local CTMS into CTRP. To make that request, send a message to the CTRP Technical Support at CTRP_Support@nih.gov. |
| 22 | Accrual Reporting | How does CTRP count accrual data on the Data Table 4 report? | CTRP counts patient accrual only once. “Center12Mos” and “CenterToDate” count accruals for a Center and all organizations defined in CTRP as part of the Center “family”. “Other12Mos” and “OtherToDate” count accruals for all organizations defined in CTRP as “Affiliates” of a Center. A Center's Organization and Affiliation* relationships are the same for all trials and is defined at the discretion of the Cancer Center. *Cancer Center “Affiliates” are institutions that have partnered with a Cancer Center to accrue patients on behalf of the center. Other NCI Designated Cancer Centers (such as multi-site trials) are NOT affiliates to Cancer Centers. |
| 23 | Accrual Reporting (Organizational, Affiliations) | Can you describe the difference between an Organization and Affiliation and how these are assigned in CTRP? | The organizational structure and related family in CTRP is defined at the discretion of the Cancer Center.
Note: The Cancer Center is responsible for collecting and submitting the data for these affiliates to the NCI. The Cancer Center responsibilities for reporting Affiliate data are not different than Cancer Center reporting (that is, National trials are reported by CTEP, DCP, CCR, multi-center Institutional trials are reported by the lead organization, Industrial trial participation is reported by the Cancer Center). |
| 24 | Accrual Reporting (Trial by Trial Basis) | Can a Cancer Center's Organizational and Affiliation relationships vary on a trial by trial basis? | No, a Cancer Center's Organizational and Affiliation relationships are the same for all trials; CTRP does not have the ability to assign Organizational and Affiliation on a trial by trial basis. |
| 25 | Accrual Reporting (Definition) | What is the definition of accrual? | Accrual is the total number of participants enrolled in the clinical trial. Enrolled means 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. For more information, refer to https://prsinfo.clinicaltrials.gov/definitions.html#IntEnrollment. |
| 26 | Basket/Umbrella Trials | How will CTRP report basket/umbrella trials for Data Table 4 reporting? | The CTRP Data Table 4 report will report basket/umbrella trials as registered in CTRP. NCI MATCH is registered in CTRP as one trial, and, as a result, it is represented on CTRP DT4 only once Each sub-trial of Pediatric MATCH is registered as a separate interventional trial. CTRP will show each sub-trial separately |
| 27 | Pediatric MATCH | What information do we need to enter for Pediatric MATCH trials as a participating site? | NCI reports Pediatric MATCH trials to CTRP. Cancer Centers will need to add their center’s Data Table 4 specific info, such as program code and target enrollment, by treatment trial. |
| 28 | Trial Phase | What are the CTRP trial phases as compared to ClinicalTrials.gov? | CTRP trial phases match those in ClinicalTrials.gov. Valid trial phases include: Early Phase I (previously Phase 0), I, II, III, IV, combinations of these phases, and N/A. CTRP does not accept Feasibility and Pilot as a Phase. CTRP supports use of Pilot Y or N for trials of all Phases. For definitions, refer to Trial Phase Value Definitions. |
| 29 | Multiple NCT IDs | Does CTRP allow us to enter duplicate trials with the same NCT ID in CTRP? | No, the CTRP Data Table 4 report does not allow reporting of two or more trials with the same ClinicalTrials.gov NCT ID; it can be represented only once. |
| 30 | Removed as a Participating Site from a Trial | I noticed a trial on my Data Table 4 report with my organization as a participating site but we never have and do not intend to participate on that trial and would like to be removed. | You will need to contact the Lead Organization to request to be removed from the trial. |
| 31 | Lead Organization Contact Information | How can I obtain contact information for a lead organization's Study Coordinator if I need to update data in CTRP where my organization is a participating site? | You can send a request to the CTRO (NCICTRO@mail.nih.gov) who will contact the lead organization on your behalf and/or send you their contact information. If not, indicate proposed updates in a note along with your Data Table 4 report. |
| 32 | Removed as a Participating Site from a Trial, Lead Organization Contact Information | How can I request to remove my organization as a participating site from a trial in which it did not and does not plan to participate? | You can send a request to the CTRO (NCICTRO@mail.nih.gov) who will contact the lead organization on your behalf and/or request the contact information for the PS and contact them directly. If not, indicate that you would like to be removed as a participating site in a note along with your Data Table 4 report. |
| 33 | Abbreviated/Industrial Trials Accrual | Industrial trial accrual (summary/cumulative) does not reflect the correct dates in CTRP for Data Table 4 reporting. | CTRP has been updated to address requested enhancements to CTRP Summary Accrual editing and viewing for Abbreviated and Other Trials. The CTRP Accrual application’s Participating Site Subject Accrual Count page now provides Cancer Centers with the ability to Add, View, and Edit summary accrual information; # of Subjects Enrolled and Cut-Off Date. Please see the User Guide for additional instructions: Recording and Updating Participating Site Accrual Counts: https://wiki.nci.nih.gov/display/CTRPdoc/Recording+and+Updating+Participating+Site+Accrual+Counts |
| 34 | Support | Will CTRP batch load data from our local CTMS into CTRP? | Yes, CTRP will batch load data upon request, such as the following:
To request a copy of the appropriate batch load template, send a message to the CTRP Technical Support at CTRP_Support@nih.gov. |
| 35 | Support | What are the approved browser types and versions for CTRP Data Table 4 report generation? | Refer to Browser Support in STRAP. |
