NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 4: Appendices Section II – Required Tables for New/Competing & Non-Competing Applications
Table 7. Summary Accrual by Major Cancer Category and Trial Phase to All Trials
(Note: This table is a condensed summary of Table 6 for the Lead Academic Participating Site applicants on page 207 and is
optional. See Table 6 for the Network Group Operations Center applicants on page 197 for suggested categories for the Major
Cancer Categories.)
Type Study Accrual
Period
(MM/DD/YYYY to
MM/DD/YYYY)
Total for Cancer Type # 1
Total for Cancer Type # 2
etc.
PILOT
Tx
Studies
PHASE 1
Treatment
Studies
PHASE 2 Treatment Studies
(includes Phase 1/2 Studies)
Screened
Only
Screened &
Intervention
Total
Patients
PHASE 3 Treatment Studies
(includes Phase 2/3 Studies)
Screened
Only
Screened &
Intervention
Total
Patients
All Treatment Studies
(Include accrual from all treatment
trials for all phases and pilot
studies; if trial does not have a
screening component, then it
should be totaled in the “screened
& intervention” component
category)*
Screened
Only
Screened &
Intervention
Grand TOTAL
(All Diseases)
* If any pilot or phase 1 treatment trials are not disease-specific (and accrual is thus not tracked by a cancer type), accrual for those trials should be listed under a
row entitled “Non-specific Cancer Type” in the table above.
Table 8. Operational Timelines for Activation of Clinical Trial Proposals at Academic Participating Site Applicant (at Academic
Center Components & Affiliates) for Studies Opened After 4/1/2010 to Date of Application Preparation (4/1/2010 to
MM/DD/YYYY) Sorted by Major Cancer Category, Start Date, and Trial #
(4/1/2010 is used as start date as prior to that date, NCI/DCTD did not have standard definitions for milestones in the study development
process)
Academic Site *
Cancer
Site
Trial
Phase
Trial Number & Brief
Title
Date Study Open
for Patient
Accrual
(Activation) by
Network Group
Leading Trial
Date Study
Submitted for
Evaluation at
Academic Center **
Date Study
Opened at
Academic
Center ***
# Days to
Activation at
Academic
Center
* List opening studies by Main Academic Center and by Lead Academic Components (e.g., academic clinics at different locations with a
different NCI institution code IF those Lead Academic Components open studies via a different process and different timeline from the main
Academic Center). Do NOT provide this information for affiliates as that information is not requested for this application.
** This is the date that the academic site began the process for evaluation of opening the study at the academic site (often starts with a
resource or other review of the study by a review committee at the site). This is NOT the date that the study is submitted for IRB review
unless submission for IRB review is done simultaneously with review of the study by the site prior to the site deciding to open the study.
*** This is the date the study was actually opened for patient enrollment at the academic site (this would be after IRB approval of the study
at the site).
Accrual
to Date
Comments
Page 208 of 241
Total
Patients