NCI National Clinical Trials Network (NCTN) Program Guidelines
NCI National Clinical Trials Network (NCTN) Program Guidelines NCI National Clinical Trials Network (NCTN) Program Guidelines
Part 4: Appendices – VII. Accrual Input by Member Institution/Sites for Network Group Operations Center Budget Request for New/Competing Applications X. Accrual Input by Member Institution/Sites for Network Group Operations Center, Canadian Collaborating Clinical Trials Network, and Network Lead Academic Participating Site Budget Requests for New Applications The Network Group Operations Center and Canadian Collaborating Clinical Trials Network (CCCTN) applicants must submit the breakdown of the accrual they anticipates from each of their member institutions/sites to all NCTN trials over the planned project period that was used as input to generate their budget requests in the budget section of their applications as “Just-in-Time” information. This table will reflect accrual from all member sites to all NCTN trials that is credited to the Network Group – both trials led by the Network Group as well as accrual credited to it for trials led by other Network Groups. A suggested format for a table to provide this information is provided below. This table should NOT be submitted with the application; it will be requested as “Just-in-Time” information. The information table that should be submitted WITH the application of the Network Group Operations Center/CCCTN is simply the list of Member Institutions/Participating Sites sorted by all US members first and then international members. Within US or International Category, the table should be sorted by Membership Status (i.e., Main Members & their Affiliates, CCOPs and MB- CCOPs, & Others) and then by country, state/province, city, and NCI Institution Code (if applicable). The list should be provided in RESOURCE section of the PHS398 of the Network Group Operations Center/CCCTN application. Suggested format for this REQUIRED TABLE is on page 238 of these Guidelines. NCTN Key Component for Application: Network Group Operations Center (or Canadian Collaborating Clinical Trials Network) Accrual Input Table To be Provided as “Just-In-Time Information” Only (Only List of Member Institutions/Participating Sites for Network Group is REQUIRED to be Provided in RESOURCE Section of PHS398 Application as Described Above with Suggested Format on Page 240) Institution Name University of XXX Health Corner Unit XXXX CCOP (or XXXX MB-CCOP) NCI Institution Code (if applicable) YY000 YY001 XX000 Membership Type Main Member Affiliate CCOP (or MB- CCOP) Type Per Case Management Funding * Basic Intervention – Therapeutic (includes pilot studies) # Patients for Per Case Funding in Category Year 1 Year 2 Year 3 Year 4 Year 5 30 30 30 30 30 Basic Intervention - Adv Imaging 5 5 5 5 5 Screening 5 5 5 5 5 Total for Screening & Intervention 40 40 40 40 40 Biospecimen Collection on Tx Trials (1 collection per patient per trial only) Basic Intervention – Therapeutic (includes pilot studies) 20 20 20 20 20 30 30 30 30 30 Basic Intervention - Adv Imaging 5 5 5 5 5 Screening 0 5 0 5 0 Total for Screening & Intervention 35 40 35 40 35 Biospecimen Collection on Tx Trials (1 collection per patient per trial only) Basic Intervention – Therapeutic (includes pilot studies) 20 20 20 20 20 30 30 30 30 30 Basic Intervention - Adv Imaging 5 5 5 5 5 Screening 5 5 5 5 5 Total for Screening & Intervention 40 40 40 40 40 Biospecimen Collection on Tx Trials 20 20 20 20 20 (1 collection per patient per trial only) ETC. * For Pediatric Network Group applicants, a row for “High Performance Intervention” should be added for the appropriate pediatric sites as those sites do not have the option of applying for the Lead Academic Participating Site awards. Page 236 of 241
Part 4: Appendices – VII. Accrual Input by Member Institution/Sites for Network Group Operations Center Budget Request for New/Competing Applications NCTN Key Component for Application: Lead Academic Participating Site Application To be Provided in the PHS398 Application The Lead Academic Participating Site applicants must submit the breakdown of the accrual they anticipates from each of their institutions/sites to all NCTN trials over the planned project period that was used as input to generate their budget requests in the budget section of their applications WITH their application in the RESOURCE Section of the PHS398 application. If the Lead Academic Participating Site application includes affiliate, the affiliate accrual must be included in this table. A suggested format for a table to provide this information is provided below. Institution Name University of XXX (Main Academic Center) University of XXX at Special Location (Lead Academic Component #1 if Academic Center has a clinic at a different location with different NCI institution code) Health Corner Affiliate ETC. NCI Institution Code (if applicable) YY002 YY003 KK000 Membership Type Lead Lead Affiliate of Lead Academic Center Included in Application Type Per Case Management Funding * # of Patients for Per Case Funding in Category Year 1 Year 2 Year 3 Year 4 Year 5 High Performance Intervention 30 30 30 30 30 Basic Intervention - Therapeutic & Pilot Studies 2 2 2 2 2 Basic Intervention - Adv Imaging 5 5 5 5 5 Screening 5 5 5 5 5 Total for Screening & Intervention 42 42 42 42 42 Biospecimen Collection on Tx Trials (1 collection per patient per trial only) 20 20 20 20 20 High Performance Intervention 30 30 30 30 30 Basic Intervention - Therapeutic & Pilot Studies 1 1 1 1 1 Basic Intervention - Adv Imaging 2 2 2 2 2 Screening 3 3 3 3 3 Total for Screening & Intervention 36 36 36 36 36 Biospecimen Collection on Tx Trials (1 collection per patient per trial only) High Performance Intervention – N/A for affiliates Basic Intervention - Therapeutic & Pilot Studies 20 20 20 20 20 N/A N/A N/A N/A N/A 10 10 10 10 10 Basic Intervention - Adv Imaging 1 1 1 1 1 Screening 0 3 0 3 0 Total for Screening & Intervention 11 14 11 14 11 Biospecimen Collection on Tx Trials (1 collection per patient per trial only) 5 6 5 6 5 * For adult cancer treatment studies, pilot treatment studies are rarely performed, hence this row may or may not show any projected accrual. Estimates for basic intervention for advanced imaging studies and screening estimates may be variable as well depending on the applicant’s past accrual history and anticipated future accrual. Page 237 of 241
- Page 185 and 186: PART 2: Submission of New/Competing
- Page 187 and 188: PART 3: Submission of Non-Competing
- Page 189 and 190: TYPE OF STUDY PART 3: Submission No
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- Page 227 and 228: Part 4: Appendices - VII. NCTN Prog
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Part 4: Appendices – VII. Accrual Input by Member Institution/Sites for <strong>Network</strong><br />
Group Operations Center Budget Request for New/Competing Applications<br />
<strong>NCTN</strong> Key Component for Application:<br />
Lead Academic Participating Site Application To be Provided in the PHS398 Application<br />
The Lead Academic Participating Site applicants must submit the breakdown of the accrual they anticipates from each of their<br />
institutions/sites to all <strong>NCTN</strong> trials over the planned project period that was used as input to generate their budget requests in the<br />
budget section of their applications WITH their application in the RESOURCE Section of the PHS398 application. If the Lead Academic<br />
Participating Site application includes affiliate, the affiliate accrual must be included in this table. A suggested format for a table to<br />
provide this information is provided below.<br />
Institution<br />
Name<br />
University of<br />
XXX<br />
(Main<br />
Academic<br />
Center)<br />
University of<br />
XXX at Special<br />
Location<br />
(Lead Academic<br />
Component #1<br />
if Academic<br />
Center has a<br />
clinic at a<br />
different<br />
location with<br />
different <strong>NCI</strong><br />
institution<br />
code)<br />
Health Corner<br />
Affiliate<br />
ETC.<br />
<strong>NCI</strong> Institution<br />
Code<br />
(if applicable)<br />
YY002<br />
YY003<br />
KK000<br />
Membership<br />
Type<br />
Lead<br />
Lead<br />
Affiliate of<br />
Lead<br />
Academic<br />
Center<br />
Included in<br />
Application<br />
Type Per Case Management Funding *<br />
# of Patients for Per Case Funding in Category<br />
Year 1 Year 2 Year 3 Year 4 Year 5<br />
High Performance Intervention 30 30 30 30 30<br />
Basic Intervention - Therapeutic & Pilot<br />
Studies<br />
2 2 2 2 2<br />
Basic Intervention - Adv Imaging 5 5 5 5 5<br />
Screening 5 5 5 5 5<br />
Total for Screening & Intervention 42 42 42 42 42<br />
Biospecimen Collection on Tx <strong>Trials</strong><br />
(1 collection per patient per trial only)<br />
20 20 20 20 20<br />
High Performance Intervention 30 30 30 30 30<br />
Basic Intervention - Therapeutic & Pilot<br />
Studies<br />
1 1 1 1 1<br />
Basic Intervention - Adv Imaging 2 2 2 2 2<br />
Screening 3 3 3 3 3<br />
Total for Screening & Intervention 36 36 36 36 36<br />
Biospecimen Collection on Tx <strong>Trials</strong><br />
(1 collection per patient per trial only)<br />
High Performance Intervention –<br />
N/A for affiliates<br />
Basic Intervention - Therapeutic & Pilot<br />
Studies<br />
20 20 20 20 20<br />
N/A N/A N/A N/A N/A<br />
10 10 10 10 10<br />
Basic Intervention - Adv Imaging 1 1 1 1 1<br />
Screening 0 3 0 3 0<br />
Total for Screening & Intervention 11 14 11 14 11<br />
Biospecimen Collection on Tx <strong>Trials</strong><br />
(1 collection per patient per trial only)<br />
5 6 5 6 5<br />
* For adult cancer treatment studies, pilot treatment studies are rarely performed, hence this row may or may not show any projected<br />
accrual. Estimates for basic intervention for advanced imaging studies and screening estimates may be variable as well depending on<br />
the applicant’s past accrual history and anticipated future accrual.<br />
Page 237 of 241
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