I N S T R U C T I O N S F O R A P P L I C A N T S

Transcription

1 I N S T R U C T I O N S F O R A P P L I C A N T S Individual Investigatr Research Awards RFA R-15-IIRA-1 Individual Investigatr Research Awards fr Preventin and Early Detectin RFA R-15-IIRAP-1 Individual Investigatr Research Awards fr Cancer in Children and Adlescents RFA R-15-IIRACCA-1 FY 2015 Fiscal Year Award Perid September 1, 2014 August 31, 2015

2 TABLE OF CONTENTS 1. INTRODUCTION SUMMARY INSTRUCTIONS APPLICATION SUBMISSION DEADLINE APPLICATION PREPARATION AND SUBMISSION PROCESS APPLICATION/AUTHORIZED SIGNING OFFICIAL (ASO) GRANTS CONTRACT/OFFICE OF SPONSORED PROJECTS OFFICIAL USER REGISTRATION AND/OR LOGIN STARTING A NEW APPLICATION STARTING A RESUBMISSION APPLICATION STARTING A RENEWAL APPLICATION STATUS DISPLAY Tab Status Applicatin Status TAB: SUMMARY TAB 1: CONTACTS TAB 2: APPLICATION INFORMATION TAB 3: COLLABORATORS AND CONFLICTS OF INTEREST TAB 4: REQUIRED DOCUMENTS TAB 5: BUDGET Senir/Key Persn & Other Persnnel Detailed Budget fr Year One Budget fr Entire Prpsed Perid f Perfrmance Budget Justificatin Salary Cap TAB 6: FINAL REVIEW & SUBMIT PRODUCT DEVELOPMENT PROVIDED TEMPLATES VERTEBRATE ANIMALS/HUMAN SUBJECTS FORMATTING INSTRUCTIONS CONTACT INFORMATION HelpDesk (Rev 5/15/14) Instructins fr Applicants p.2/31

3 23.2. Scientific and Prgrammatic Questins APPENDIX 1: DESCRIPTION OF RESEARCH AREAS APPENDIX 2: PROGRAM FOCUS - DEFINITIONS OF CANCER RESEARCH TYPES (Rev 5/15/14) Instructins fr Applicants p.3/31

4 VERSION HISTORY Rev 5/15/14 Dcument psted (Rev 5/15/14) Instructins fr Applicants p.4/31

5 1. INTRODUCTION The Cancer Preventin & Research Institute f Texas () Applicatin Receipt System (CARS) ( prvides a means fr the research cmmunity (i.e., Principal Investigatrs [PIs] and Applicatin/Authrized Signing Officials [ASOs]) t respnd t funding pprtunities electrnically ver the Internet thrugh a secure cnnectin. This dcument prvides instructins and guidance t applicants t submit an applicatin in respnse t s Request fr Applicatins (RFA) fr Individual Investigatr Research Awards (RFA R-15-IIRA-1), Individual Investigatr Research Awards fr Preventin and Early Detectin (RFA R-15-IIRAP-1), and (RFA R-15-IIRACCA-1). Applicatins may be submitted frm May 15, 2014, thrugh June 26, SUMMARY INSTRUCTIONS Technical Supprt: Applicants are strngly advised t carefully read this dcument in its entirety befre starting an applicatin. The HelpDesk (Sectin 23.1) is available t answer technical questins and guide applicants with applicatin submissin. This Instructins dcument will be updated as necessary. Revisins will be listed in the Revisin Histry. Dcument Frmat fr Upladed Files: Use Prtable Dcument Frmat (PDF) nly. D NOT passwrd prtect dcuments. D NOT submit dcuments that are bund tgether in a single PDF package. Fnt Type/Size: Arial (11 pint), Calibri (11 pint), r Times New Rman (12 pint). Page Frmat: Single spacing, 0.75-inch margins in all directins. Templates: Use the prvided templates fr bigraphical sketches (bisketches), the prduct develpment plan, and current and pending supprt. Prduct Develpment Plan: A prduct develpment plan is required fr prpsed research that will lead t the develpment f a prduct that requires regulatry filing. (Rev 5/15/14) Instructins fr Applicants p.5/31

6 Submissin Prcess: The applicant cmpletes/finalizes all sectins and frwards it t the rganizatin s ASO fr review and final submissin t. The ASO is an individual authrized t submit an applicatin fr the rganizatin. The applicatin must be submitted by the ASO n r befre June 26, 2014, 3 p.m., Central Time. Nte: CARS will be unavailable the third Thursday f each mnth between 7 p.m. and 9 p.m. Central Time fr rutine system maintenance Tab Finalizatin and Reset: Applicatin infrmatin saved as draft can be edited at a later time. Once applicatin infrmatin is finalized fr ASO apprval, it can be edited nly after an ASO has reset the sectin t draft mde at the request f the PI. 3. APPLICATION SUBMISSION DEADLINE The applicatin must be submitted n r befre June 26, 2014, 3 p.m. Central Time. 4. APPLICATION PREPARATION AND SUBMISSION PROCESS The applicant cmpletes/finalizes a series f numbered tabs f the applicatin. Finalized tabs can be reset by the ASO. Once all tabs are finalized, the ASO reviews, apprves, and submits the applicatin t. 5. APPLICATION/AUTHORIZED SIGNING OFFICIAL (ASO) The ASO is an individual authrized t submit an applicatin n behalf f an rganizatin. An ASO is required n the applicatin and must be identified by the PI. As the rganizatin s representative, the ASO is required t review the tabs finalized by the PI and subsequently submit the applicatin. Only the ASO is authrized t fficially submit the applicatin t. The ASO can reset PI-finalized tabs t draft at the request f the PI. (Rev 5/15/14) Instructins fr Applicants p.6/31

7 6. GRANTS CONTRACT/OFFICE OF SPONSORED PROJECTS OFFICIAL The Grants Cntract/Office f Spnsred Prjects Official is the individual wh will manage the grant if an award is made. This individual must be identified fr the applicatin. The PI r the ASO can assign this individual t this rle. 7. USER REGISTRATION AND/OR LOGIN Applicants begin the applicatin prcess by registering r lgging int CARS ( On successful lgin int the system, applicants will be presented with the My Applicatins page shwn n the next page. All prir submitted applicatins by that user are listed n this page. After initial registratin r after lgin, all users are encuraged t cmplete/verify the infrmatin under the My Prfile link n the tp left f this screen. A bisketch is required fr the PI and the C-Principal Investigatr (C-PI). (Rev 5/15/14) Instructins fr Applicants p.7/31

8 8. STARTING A NEW APPLICATION New applicatins can be started in ne f tw ways: 1. My Applicatins (this is the default page after lgin) click start a new applicatin FY 2015 Research Prgrams Individual Investigatr Research Awards r Individual Investigatr Research Awards fr Preventin and Early Detectin r click New Applicatin, r 2. Current Funding Opprtunities click FY 2015 Research Prgrams Individual Investigatr Research Awards r Individual Investigatr Research Awards fr Preventin and Early Detectin r Individual Investigatr Research Awards fr Cancer in Children and Adlescents click Start New Applicatin. Upn starting a new applicatin, applicants are required t enter the title f the applicatin (160 character limit; can be edited later) and select the submitter rle. D NOT use symbls r special characters these will nt be transmitted crrectly. Once this step is cmpleted, applicants will be directed t the summary page. Applicants are advised t carefully read the infrmatin n the summary page befre mving n t the numbered tabs. All tabs must be successfully cmpleted/finalized by the applicant befre the ASO can review, apprve, and successfully submit the applicatin. Tab 1 (Cntacts) must be cmpleted/finalized prir t Tab 3 (Cllabratrs & COIs). Tab 2 (Applicatin Infrmatin) must be cmpleted/finalized prir t Tab 4 (Required Dcuments) and Tab 5 (Budget). 9. STARTING A RESUBMISSION APPLICATION Resubmissin applicatins may be submitted fr previusly nt funded Individual Investigatr Research Awards applicatins nly. Because Individual Investigatr Research Awards fr Preventin and Early Detectin and Individual Investigatr Research Awards fr Cancer in Children and Adlescents are the new mechanisms, resubmissin is nt available under RFA R-15-IIRAP-1 and RFA R-15-IIRACCA-1. If a previusly unfunded IIRA applicatin is respnsive t the IIRAP r IIRACCA RFA, it may be submitted as a new applicatins under ne f these award mechanisms. (Rev 5/15/14) Instructins fr Applicants p.8/31

9 An IIRA Resubmissin Applicatin can be started frm the My Applicatins page by clicking the Start Resubmissin Applicatin link f a previusly nt funded applicatin. Upn starting a resubmissin applicatin, applicants may revise the title f the applicatin (preppulated frm the previus submissin; 160 character limit), and select the submitter rle. D NOT use symbls r special characters these will nt be transmitted crrectly. Once this step is cmpleted, applicants will be directed t the summary page. IMPORTANT: Mre than ne resubmissin is nt permitted. An applicatin is cnsidered a resubmissin if the prpsed prject is the same prject as presented in the riginal submissin. A change in the identity f the Applicant r cmpany representative fr a prject that was previusly submitted t des nt cnstitute a new applicatin; the applicatin wuld be cnsidered a resubmissin. NOTE: Only the title f the previusly submitted applicatin is preppulated fr a resubmissin applicatin. All ther infrmatin, including the C-PI, cllabratrs, COIs, and all required dcuments must be submitted afresh. If a summary statement was prepared fr the previus applicatin, it will be autmatically upladed as part f the resubmissin applicatin (see Sectin 16: Tab 4, Required Dcuments). If a summary statement was nt prepared, n dcument will be upladed. Applicants are advised t carefully read the infrmatin n the summary page befre mving n t the numbered tabs. All tabs must be successfully cmpleted/finalized by the applicant befre the ASO can review, apprve, and successfully submit the applicatin. Tab 1 (Cntacts) must be cmpleted/finalized prir t Tab 3 (Cllabratrs & COIs). Tab 2 (Applicatin Infrmatin) must be cmpleted/finalized prir t Tab 4 (Required Dcuments) and Tab 5 (Budget). (Rev 5/15/14) Instructins fr Applicants p.9/31

10 10. STARTING A RENEWAL APPLICATION Renewal applicatins may be submitted fr funded Individual Investigatr Research Awards. An applicatin riginally funded by as an IIRA that is apprpriate fr the IIRAP r IIRACCA mechanism may be submitted under RFA R-15-IIRAP-1 r RFA R- 15-IIRACCA-1, respectively, fr a cmpetitive renewal. Renewal applicatins can be started frm the My Applicatins page by clicking the Start Renewal Applicatin link f a previusly funded applicatin. Optins t Select Renewal Applicatin Award Type will appear n the screen. The apprpriate award mechanism under which the renewal will be submitted must be selected. After selecting the award mechanism, instructins and requirements fr selected mechanism, as specified in the apprpriate RFA, must be fllwed. Upn starting a renewal applicatin, applicants may revise the title f the applicatin (preppulated frm the previus submissin; 160 character limit) and select the submitter rle. D NOT use symbls r special characters these will nt be transmitted crrectly. Once this step is cmpleted, applicants will be directed t the summary page. NOTE: Only the title f the previusly funded Individual Investigatr Research Award is preppulated fr a renewal applicatin. All ther infrmatin, including the C-PI, cllabratrs, COIs, and all required dcuments must be submitted afresh. Applicants are advised t carefully read the infrmatin n the summary page befre mving n t the numbered tabs. All tabs must be successfully cmpleted/finalized by the applicant befre the ASO can review, apprve, and successfully submit the applicatin. Tab 1 (Cntacts) must be cmpleted/finalized prir t Tab 3 (Cllabratrs & COIs). Tab 2 (Applicatin Infrmatin) must be cmpleted/finalized prir t Tab 4 (Required Dcuments) and Tab 5 (Budget). (Rev 5/15/14) Instructins fr Applicants p.10/31

11 11. STATUS DISPLAY Tab Status The status f each tab is displayed under the rw f numbered tabs. The figure belw is an example f the status f Tab 1. Status DRAFT PENDNG ASO APPROVAL ASO APPROVED AND SUBMITTED Status Definitin The tab is being prepared by the applicant. The tab has been finalized by the applicant. When all tabs are finalized and reflect this status, the ASO will receive e- mail ntificatin stating that the applicatin can be reviewed/submitted. The applicant is included n this ntificatin. The ASO has reviewed, apprved, and submitted the applicatin t. Once the applicatin has been submitted by the ASO, the PI is ntified via Applicatin Status The status displayed under the rw f numbered tabs n the Summary tab indicates the status f the applicatin (as indicated in the figure abve). (Rev 5/15/14) Instructins fr Applicants p.11/31

12 12. TAB: SUMMARY The status f each tab is als displayed n this page. Status definitins are described belw. Sectin Status Status Definitin draft pending ASO apprval NOT APPROVED PENDING The tab is being prepared by the applicant. The tab has been finalized by the applicant. When all tabs are finalized and reflect this status, the ASO will receive ntificatin that the applicatin can be reviewed/submitted. The applicant is included n this ntificatin. The applicatin has nt been apprved/submitted by the ASO. All tabs have been finalized by the applicant and reflect the status pending ASO apprval. At this pint, the applicatin is awaiting ASO apprval and subsequent submissin. NOTE: As stated in the preceding sectin, the status displayed under the rw f numbered tabs n this page indicates the status f the entire applicatin. (Rev 5/15/14) Instructins fr Applicants p.12/31

13 13. TAB 1: CONTACTS Principal Investigatr: Verify infrmatin fr the PI; update as necessary. C-Principal Investigatr (Optinal): Only ne C-PI may be designated n an Individual Investigatr Research Award applicatin. If a C-PI is t be designated n the applicatin, fllw these steps: Click the Search fr C-Principal Investigatr buttn. Enter infrmatin and click the Search Cntacts buttn. If the individual is listed n the subsequent search results page, that individual may be added t the applicatin via the Add Cntact link. If the individual is nt listed, different search criteria may be used (fr example, using the last name nly r spelling variatins). Alternatively, the individual may be invited t register in CARS and be part f the applicatin by clicking the Send Invitatin link. On the subsequent page, cmplete the fields and click the Send Invitatin buttn. When this individual jins the applicatin as a C-PI, his/her infrmatin will be listed in the apprpriate sectin f the tab. Change r remve an individual by clicking the apprpriate buttn. Alternate Submitter (Optinal): An alternate submitter may be designated n the applicatin by the PI. Fllw the search guidelines abve. Applicatin Signing Official (Required): An ASO must be listed in rder t cmplete/finalize this tab. Click the Search fr Applicatin Signing Official buttn. Fllw the search guidelines abve. Alternate Applicatin Signing Official (Optinal): This individual can be assigned nly by the ASO. Fllw the search guidelines abve. Grants Cntract/Office f Spnsred Prjects Official: A Grants Cntract/Office f Spnsred Prjects Official must be listed in rder t cmplete/finalize this tab. This individual can be assigned by the PI r the ASO. Fllw the search guidelines abve. (Rev 5/15/14) Instructins fr Applicants p.13/31

14 When all infrmatin is entered, click the Finalize Cntacts Sectin buttn. Nte that this tab cannt be finalized until the three required fields f this sectin, namely, Principal Investigatr, Applicatin Signing Official, and Grants Cntract/Office f Spnsred Prjects Official have been cmpleted. PI infrmatin is entered autmatically; an ASO must be identified and added by the PI. The Grants Cntract/Office f Spnsred Prjects Official may be identified and added by the PI r the ASO. 14. TAB 2: APPLICATION INFORMATION Applicatin Identificatin Award Mechanism: Verify the listed award mechanism. Nte that the award mechanism cannt be changed here. Applicatin Type: Verify applicatin type (drp list defaults t New Applicatin, Resubmissin, r Renewal, as applicable). Applicatin Title: The applicatin title is stated. Edit if necessary. Prject Infrmatin Cntract Start Date (m/d/yyyy): The cntract start date f 3/1/2015 is preppulated. Prpsed End Date (m/d/yyyy): Enter the prpsed end date f the prject. The maximum duratin is 3 years (36 mnths) fr IIRA and IIRAP applicatins and 4 years (48 mnths) fr IIRACCA applicatins. Prduct Develpment: If the prpsed research will lead t the develpment f a prduct that requires regulatry filing (see Sectin 19), applicants must cmplete the Prduct Develpment Plan (use the template psted under the Summary tab). This dcument must be submitted via Tab 4 (Required Dcuments). Applicatin Classificatin: Research Area: Select the research area that best describes the prpsed wrk. Please refer t the Appendix (Sectin 24) fr a detailed descriptin f each research area. (Rev 5/15/14) Instructins fr Applicants p.14/31

15 Preventin Research Fcus: If yu apply fr the Individual Investigatr Research Awards fr Preventin and Early Detectin, please indicate if yu are applying fr labratry and clinical research r ppulatin-based research. Prgram Fcus: Select the fcus f the prpsed wrk. Please refer t Appendix 2 (Sectin 25) fr the definitins f cancer research types. Cancer Site Addressed: Select the cancer site(s) that will be addressed during the prpsed prject and that mst clsely represents the fcus f yur wrk. The selectin f cancer sites in this sectin assists with reprting n cancer research that is being perfrmed. If the prpsed prject relates t all cancer types r fcuses n general cancer research, select All Sites frm the list. If the prpsed prject fcuses n multiple cancer sites, but nt all sites, please select nly the sites fr which actual wrk will be perfrmed. If the prpsed prject is related t cancer f the esphagus, please select Head and Neck frm the list. Vertebrate Animals: Indicate whether vertebrate animals will be used. Bilgic/Anatmic Substances: Indicate whether cadavers will be used. In additin, specify the use f human anatmical substances. If human anatmical substances will be used, specify if the substances are traceable t specific dnrs. Als, select applicable safety prvisins. Human Subjects: Indicate whether human subjects will be used. Specify the gender, age, and ethnicity f the study ppulatin. Specify the methd f data cllectin. Prvide the general demgraphic fcus. Select the type f clinical trial, if applicable. State Legislative Districts State Senate District: Enter the State Senate District f yur institutin. Use the link prvided t find this infrmatin using the applicant s institutinal address. State Huse District: Enter the State Huse District f yur institutin. Use the link prvided t find this infrmatin using the applicant s institutinal address. (Rev 5/15/14) Instructins fr Applicants p.15/31

16 Cancellatin f Applicatins/Awards by Granting Organizatin (in past 5 years) Select whether the PI is currently eligible t receive Federal grant funds. If N is selected, prvide a reasn. Select whether the PI had an applicatin r award terminated fr cause within the last 5 years. If yes, then select the categry f Applicatin r Award. Select the Granting Organizatin. Enter the Award Title, Award Number, Award Amunt, and the Reasn fr Cancellatin. Click the Add Applicatin/Award link t add additinal applicatins r awards. Dnatins: Select whether the PI r any individual listed n the applicatin has made a dnatin, gift, r grant t, the Fundatin, the Texas Cancer Calitin, r any nnprfit rganizatin/entity established t benefit. If yes, then enter the name f the dnr, entity name, dnatin amunt, and date f dnatin. Click the Add Dnatin link t add additinal dnatins. Pririties Addressed (frm Statute r Texas Cancer Plan): Chse the pririty addressed in the applicatin. Mre than ne pririty may be selected. If chice 5 is selected, then enter the name f the research spnsr and the spnsr s pririty that the applicatin addresses. Review the instructins and click the apprpriate buttn (Save Applicatin Infrmatin as Draft r Finalize Applicatin Infrmatin fr ASO Apprval) t save entered applicatin infrmatin. NOTE: Applicatin infrmatin saved as draft can be edited at a later time. Applicatin infrmatin finalized fr ASO apprval can be edited nly after the ASO has reset the applicatin t draft mde at the request f the PI. (Rev 5/15/14) Instructins fr Applicants p.16/31

17 15. TAB 3: COLLABORATORS AND CONFLICTS OF INTEREST Investigatrs and Submitters: Ensure that bisketches fr the PI and C-PI (if designated) are upladed. If the bisketches are missing, they can be upladed under the My Prfile link via that individual s accunt. This tab cannt be finalized withut the bisketch f the PI and C-PI (if designated). Please nte that the Bisketch that is in My Prfile when Tab 3 (Cllabratrs & COIs) is finalized will be reflected in the final applicatin. Please make sure that yu make any updates in the Bisketch befre finalizing this Tab. Any changes after this pint will be saved in My Prfile but will nt be cpied t the final versin f this applicatin. Cllabratrs and Cnflicts f Interest (COIs): Enter infrmatin fr all cllabratrs and COIs (select the apprpriate Rle fr Applicatin frm the drp list). Click the Save as Draft buttn t save additins. Cllabratrs Listed: Review the list t ensure that all entered cllabratrs have been successfully added. Cnflicts f Interest (COIs) Listed: Review the list t ensure that all entered COIs have been successfully added. When all infrmatin is entered, click the Finalize Cllabratrs and COIs buttn. Nte that this tab can be finalized nly after Tab 1 (Cntacts) has been finalized. 16. TAB 4: REQUIRED DOCUMENTS NOTE: All dcuments must be upladed in PDF frmat nly. The system will nt allw uplad f dcuments in ther frmats r f dcuments that exceed the page limits specified in the individual RFAs. D NOT passwrd prtect dcuments. D NOT submit dcuments that are bund tgether in a single PDF package. (Rev 5/15/14) Instructins fr Applicants p.17/31

18 Applicatin Abstracts: Abstract and Significance and Laypersn s Summary: Enter the Abstract and Significance (5,000 characters) and Laypersn s Summary (2,000 characters) f the prpsed wrk. Character limits include letters, spaces, and punctuatins. D NOT use symbls r special characters (e.g., Greek letters) these will nt be transmitted crrectly. Save the entered infrmatin by clicking the Save Applicatin Abstracts as Draft buttn. Infrmatin must be saved befre any dcuments are upladed belw r else the abstract and significance and/r laypersn s summary will be lst when the uplad refreshes the Web page. Gals and Objectives: Please enter yur Gals and Objectives as plain text (1,200 characters per Gal and per Objective). Gals and Objectives will be reviewed during the evaluatin f annual prgress reprts. HTML frmatting, tables, charts, and diagrams are nt supprted. Gals and Objectives may be saved as a DRAFT at any time by clicking the Gals and Objectives as Draft buttn. Any unsaved Gals and Objectives will be lst. At least ne Gal and ne Objective are required. At least ne Objective is required per Gal. Up t 5 Gals and 5 Objectives per Gal may be entered. Click the Add Objective link t add an additinal Objective t a Gal. Click the Add Gal link t add additinal Gals. Timeline: Uplad Timeline PDF dcument (1 page). Timeline will be reviewed during the evaluatin f annual prgress reprts. Resubmissin Summary: This is applicable fr IIRA Resubmissins nly. Uplad the Resubmissin Summary PDF dcument (1 page). This ptin is available fr resubmissin applicatins nly. Renewal Summary: Uplad the Renewal Summary PDF dcument (2 pages). This ptin is available fr renewal applicatins nly. Describe and demnstrate that apprpriate/adequate prgress been made n the current funded award t warrant further funding. Publicatins and manuscripts in press that have resulted frm wrk perfrmed during the initial funded perid shuld be listed the Renewal Summary. (Rev 5/15/14) Instructins fr Applicants p.18/31

19 Research Plan: Uplad the Research Plan PDF dcument (up t 10 pages) (see RFA fr details). Vertebrate Animals and/r Human Subjects: Uplad the Vertebrate Animals and/r Human Subjects PDF dcument (1 page). If nt applicable, uplad a page with the fllwing statement: N vertebrate animals and/r human subjects will be used. Publicatins/References: Uplad the Publicatins/References PDF dcument. Bigraphical Sketches f tw additinal Key Persnnel: If desired, up t tw additinal bigraphical sketches fr key persnnel may be prvided (use the template psted under the Summary tab). Bisketches must nt exceed 2 pages fr each individual. If tw bisketches are being prvided, these must be cmbined int a single file and submitted as a single PDF dcument (i.e., a 4-page dcument cnsisting f tw 2-page bisketches.) Bisketches f the PI and the C-PI (if designated) are extracted frm their respective prfiles and are autmatically part f the applicatin; these shuld nt be part f this dcument. Current and Pending Supprt: Fr all persnnel fr whm a bisketch is submitted with the applicatin, uplad their current and pending supprt (use the template psted under the Summary tab). Multiple dcuments must be cmbined and submitted as a single PDF dcument. At a minimum, the current and pending supprt f the PI and C-PI (if designated) must be included in this dcument. Prduct Develpment Plan: If applicable, uplad the Prduct Develpment Plan PDF dcument. The Prduct Develpment Plan must be submitted as a single PDF dcument. Institutinal/CllabratrSupprt and/r Other Certificatin: If applicable/desired, uplad letters f institutinal and/r cllabratr supprt and ther certificatin dcuments (up t 4 pages). Multiple letters/files must be cmbined and submitted as a single PDF dcument. Applicants are strngly advised nt t submit appendix material, such as publicatins, figures, and/r data. (Rev 5/15/14) Instructins fr Applicants p.19/31

20 Clinical Trial Plan: If yu are planning t cnduct clinical trials as part f yur prpsed prject, please submit required dcumentatin as a single PDF file via t the HelpDesk at help@grants.rg. In this dcument, please include the clinical trial prtcl, infrmed cnsent dcument, and a letter f drug availability frm the spnsr if the trial is using an investigatinal drug. may require institutinal review bard (IRB) apprval prir t the initiatin f funding. Summary Statement f Previus Applicatin: Applicable fr IIRA Resubmissins nly. If a summary statement was prepared fr the previus applicatin, it will be autmatically upladed as part f a resubmissin applicatin. Applicants can view the summary statement prir t finalizing the sectin. If a summary statement was nt prepared, n dcument is upladed. When all infrmatin is entered, click the Finalize Required Dcuments buttn. 17. TAB 5: BUDGET This tab shuld include nly the amunt requested frm ; d NOT include the amunt f the matching fund. The budget sectin is cmpsed f fur subtabs: 1. Senir/Key Persn & Other Persnnel 2. Detailed Budget fr Year One 3. Budget fr Entire Prpsed Perid f Perfrmance 4. Budget Justificatin All fur subtabs must be cmpleted t finalize this sectin. A detailed budget fr the first year f the prject is required. Fr Individual Investigatr Research Awards, an applicant may request $300,000 per year, inclusive f direct and indirect charges, fr up t 3 years. Fr Individual Investigatr Research Awards fr Preventin and Early Detectin, an applicant may request $500,000 per year, inclusive f direct and indirect charges, fr up t 3 years fr labratry and clinical research and up t $1,000,000 in ttal csts per year fr up t 3 years fr ppulatin-based research. (Rev 5/15/14) Instructins fr Applicants p.20/31

21 Fr Individual Investigatr Research Awards fr Cancer in Children and Adlescents, the applicants may request a maximum f $500,000 per year, inclusive f direct and indirect charges, fr a perid f up t 4 years. Exceptins t the limits per year may be requested if extremely well justified (see Sectins 4 f the RFAs). NOTE: Sme r all f the fllwing buttns appear n each subtab: Previus = Mve t the previus subtab Next = Mve t the next subtab Save Budget as Draft = Save entered infrmatin Finalize Budget fr ASO Apprval = Finalize sectin The Previus and Next buttns allw the user t mve between subtabs while retaining entered infrmatin fr as lng as the user is n the Budget tab. Infrmatin entered n any subtab is NOT saved until the Save Budget as Draft buttn is clicked. Mving t anther tab withut saving will result in lss f any unsaved changes Senir/Key Persn & Other Persnnel Cmplete the requested infrmatin. First Name and Last Name: The PI s name is preppulated. Enter names f ther individuals as necessary. Additinal rws will autappear nce text is entered int the existing last rw. Rle n Prject: The PI s rle is preppulated. Enter rles f ther individuals as necessary. Type Appt. (Mnths): Fr each individual listed, enter their appintment type, e.g., 6- mnth, 9-mnth, 12-mnth appintment. Annual Base Salary: Fr each individual listed, enter their institutinal base salary. The salary cap fr awards fr FY 2015 (September 1, 2014, thrugh August 31, 2015) is $200,000; see Sectin 17.5, Salary Cap. Effrt n Prject: Fr each individual listed, enter their percent effrt n the prject. (Rev 5/15/14) Instructins fr Applicants p.21/31

22 Salary Requested: After entering the infrmatin in these categries, click Calc t autcalculate the requested salary. Fringe Benefits: Fr each individual listed, his/her institutinal fringe benefits must be calculated based n their direct Salary Requested. Fringe benefits may nt exceed 35 percent f the salary requested (a warning will be displayed) Detailed Budget fr Year One Prvide the infrmatin requested fr ther direct charges in the first year f the prject. Travel: Include any prject-related travel charges. cannt supprt patient-related travel charges. funds may be used t send up t tw peple t s annual cnference. Equipment (400-character limit): Itemize as necessary. Equipment having a useful life f mre than 1 year and an acquisitin charge f $5,000 r mre per unit must be specifically apprved by. Preapprval is nt required; if the prject is funded, apprval may be requested at that time. Supplies (800-character limit): Itemize by categry as necessary. Cnsultant Charges: State charges fr cnsulting services that may be used during the prpsed wrk. Cntractual (Subaward/Cnsrtium) (400-character limit): Itemize all subaward- and cnsrtium-assciated amunts. State direct charges nly. Each subaward must be itemized in the Budget Justificatin subtab by stating prject charges fr persnnel, travel, equipment, supplies, cnsultants, research-related subjects, and ther expenses. Research-Related Subject Charges: Enter charges assciated with subjects related t the prpsed wrk (e.g., charges assciated with participatin f human subjects in clinical trials). cannt supprt patient-related travel charges. Other (800-character limit): Itemize ther prject-assciated expenses. (Rev 5/15/14) Instructins fr Applicants p.22/31

23 Indirect Charges: limits indirect charges t a maximum f 5 percent. Ttal Indirect Charges fr Year One (line D) shuld nt exceed 5 percent f the Ttal Charges fr Year One (line E). As an example, fr a ttal award f $100,000, indirect charges may nt exceed $5,000; direct charges wuld be $95,000. Calculate as fllws: Ttal Indirect Charges = (Ttal Direct Charges/0.95) Ttal Direct Charges. Nte fr Subawards: Subawards may recver indirect charges f up t the maximum f 5 percent f the ttal requested subaward amunt. Hwever, because awards will be made t the primary institutin (which, in turn, will manage the subcntracts), the indirect charges fr each subcntract are calculated as part f the ttal amunt requested by the primary institutin. D nt include indirect charges in the Cntractual (Subaward/Cnsrtium) categry. The apprpriate subaward amunt including the allwable indirect charges will be frwarded t the subcntracting institutin by the primary institutin Budget fr Entire Prpsed Perid f Perfrmance Amunts fr Budget Year One will be autppulated based n the infrmatin prvided n the previus subtabs, namely, Senir/Key Persn & Other Persnnel and Detailed Budget fr Year One. Fr each additinal year f supprt requested, enter the budget requested fr persnnel charges and ther applicable direct charges. Fringe benefits may nt exceed 35 percent f the salary (a warning will be displayed). Cst adjustments f up t a 3-percent annual increase fr salary and ther categries are permitted fr Years 2 and 3. A 3-percent salary increase fr Years 2 and 3 is permitted up t the cap f $200,000. The salary cap (Sectin 17.5) may be revised every year at s discretin. Enter the indirect charges fr each additinal year f supprt requested. Ttal Indirect Charges (line D) shuld nt exceed 5 percent f the ttal requested award amunt fr that year (sum f lines C and D). Calculate as fllws: Ttal Indirect Charges = (Ttal Direct Charges/0.95) Ttal Direct Charges. (Rev 5/15/14) Instructins fr Applicants p.23/31

24 17.4. Budget Justificatin Prvide a brief and cncise justificatin f the budget (15,000-character limit) fr the entire prpsed perid f supprt fr all charge categries: Persnnel (salaries and fringe benefits), travel, equipment, supplies, cnsultant charges, cntractual (subaward/cnsrtium) charges, research-related subject charges, ther expenses (including animal care charges), and indirect charges. Each subaward must itemize prject charges fr all charge categries. If mre than the maximum dllar amunt is requested in any year(s) f the prpsed budget f an applicatin, include a special and clearly labeled sectin that explains the request. NOTE: If the text fr the budget justificatin is prepared using Micrsft Wrd, applicants are advised t first cpy and paste this text int a plain-text editr such as Ntepad r WrdPad (t remve all frmatting) befre cpying and pasting it int the receipt system s text entry field. The fllwing is an example f minimal frmatting that translates cleanly t the final utput f the budget sectin f the applicatin. Headings in upper case, n bullets, and an additinal hard return between paragraphs and sectins imprve legibility. N tabs r tables are used. HEADING 1 * <Justificatin itemizatin 1> * <Justificatin itemizatin 2> HEADING 2 Sub-Heading 2.1 <Justificatin text> Sub-Heading 2.2 <Justificatin text> HEADING 3 <Justificatin text> (Rev 5/15/14) Instructins fr Applicants p.24/31

25 17.5. Salary Cap The salary cap fr awards in FY 2015 (September 1, 2014, thrugh August 31, 2015) is $200,000. Thus, the maximum direct salary supprt an individual can request is up t $200,000 f their institutinal salary based n effrt n a prject: With 100 percent effrt n the prject, individuals with an institutinal base salary f less than $200,000 wuld request the entire base salary amunt. With 100 percent effrt n the prject, individuals with an institutinal base salary f mre than $200,000 wuld request the salary cap f $200,000. With 50 percent effrt n the prject, individuals with an institutinal base salary f mre than $200,000 wuld request $100,000. The fllwing table utlines the salary cap guidelines. Institutinal fringe benefits shuld be calculated based n the direct salary supprt requested. Base institutinal salary (full-time calendar appintment) Effrt n prject Maximum direct salary supprt that wuld be requested by the applicant Less than $200, % Up t base salary Mre than $200,000 (e.g., $300,000) Mre than $200,000 (e.g., $300,000) 100% $200,000 50% $100,000 (Rev 5/15/14) Instructins fr Applicants p.25/31

26 18. TAB 6: FINAL REVIEW & SUBMIT When Tabs 1 thrugh 5 have been cmpleted and finalized by the applicant, the status f the applicatin is set t PENDING ASO APPROVAL. The ASO will then receive e- mail ntificatin t review, apprve, and submit the applicatin t. Only the ASO is authrized t fficially submit the applicatin. The ASO must lg in t the system and click the apprpriate applicatin ID number listed under his r her My Applicatins page. T submit the applicatin, the ASO must enter his r her passwrd and click the Apprve and Submit Applicatin buttn. The ASO will then be asked t click the Cntinue buttn t submit the applicatin. After the applicatin has been submitted, the status f the applicatin n the My Applicatins page (and als n all tabs f that applicatin) will be ASO APPROVED AND SUBMITTED. The ASO at the PI s institutin must submit the applicatin by the submissin deadline: June 26, 2014, 3 p.m., Central Time. 19. PRODUCT DEVELOPMENT If the prpsed research will lead t the develpment f a prduct that requires regulatry filing, applicants must cmplete the Prduct Develpment Plan using the template prvided (psted under the Summary tab). 20. PROVIDED TEMPLATES Applicants must use the prvided templates t prepare and submit the fllwing dcuments. Templates are psted under the Summary tab and are available in.dc and.pdf frmat. Bigraphical Sketch (.dc,.pdf) Prduct Develpment Plan (.dc,.pdf) Current and Pending Supprt (.dc,.pdf) (Rev 5/15/14) Instructins fr Applicants p.26/31

27 21. VERTEBRATE ANIMALS/HUMAN SUBJECTS Whenever vertebrate animals r human subjects are part f a -funded prject, a cpy f the recipient rganizatin s Institutinal Review Bard (IRB) and/r Institutinal Animal Care and Use Cmmittee (IACUC) apprval must be prvided t befre funding can be released. Fr multi-year prjects, annual cnfirmatin f IRB r IACUC apprval is required. This infrmatin is nt required at the time f submissin f the applicatin. 22. FORMATTING INSTRUCTIONS All sectins f the applicatin shuld be written in clear and legible text and must fllw the guidelines described belw. Applicants are advised t use fnt sizes, fnt faces, line spacing, page sizes, and page margins that permit easy readability f the applicatin text. Every attempt shuld be made t keep files sizes t a minimum (see Scanning Reslutin belw). Applicatins that d nt meet these guidelines are subject t administrative withdrawal. Frmatting guidelines fr all submitted applicatins are as fllws: Language: English. Dcument Frmat: PDF nly. Fnt Type/Size: Arial (11 pint), Calibri (11 pint), r Times New Rman (12 pint). Line Spacing: Single. Page Size: 8.5 x 11 inches. Margins: 0.75 inch, all directins. Clr and High-Reslutin Images: Images, graphs, figures, and ther illustratins must be submitted as part f the apprpriate submitted dcument. Applicants shuld include text t explain illustratins that may be difficult t interpret when printed in black and white. Scanning Reslutin: Images and figures must be f lwest reasnable reslutin that permits clarity and readability. Unnecessarily large files will NOT be accepted, especially thse that just include nly text. (Rev 5/15/14) Instructins fr Applicants p.27/31

28 References: Applicants shuld use citatin style that includes the full name f the article and that lists at least the first three authrs. Official jurnal abbreviatins may be used. An example is included belw; hwever, ther citatin styles meeting these parameters are als acceptable as lng as the jurnal infrmatin is stated. Include URLs f publicatins referenced in the applicatin. Smith, P.T., De, J., White, J.M., et al (2006). Elabrating n a nvel mechanism fr cancer prgressin. Jurnal f Cancer Research 135, Internet URLs: Applicants are encuraged t prvide the URLs f publicatins referenced in the applicatin; hwever, applicants shuld nt include URLs directing reviewers t Web sites cntaining additinal infrmatin abut the prpsed research. Headers and Fters: These shuld nt be used unless they are part f a prvided template. Page numbers may be included in the fter (see fllwing pint). Page Numbering: Add page numbers in the fter fr each dcument that is upladed as a PDF. Restart the page numbering at 1 fr each dcument. Pages shuld be numbered at the bttm right crner f each page. Supplemental ( Appendix ) Material: These are permitted nly if certificatin dcuments and/r clinical trial prtcls are vital t the evaluatin f the prpsed research study. Applicants are strngly advised nt t submit publicatins, figures, and/r data. All attachments that require signatures must be filled ut, printed, signed, scanned, and then upladed in PDF frmat. (Rev 5/15/14) Instructins fr Applicants p.28/31

29 23. CONTACT INFORMATION HelpDesk HelpDesk supprt is available fr technical questins regarding user registratin and nline submissin f applicatins. Queries submitted via will be answered within 1 business day. HelpDesk staff is nt in a psitin t answer questins regarding scientific aspects f applicatins. Dates f peratin: May 15, 2014, t June 26, 2014 (excluding public hlidays) Hurs f peratin: Mnday, Tuesday, Thursday, Friday, 7 a.m. t 4 p.m. Central Time Wednesday, 8 a.m. t 4 p.m. Central Time Tel: ResearchHelp@Grants.rg Scientific and Prgrammatic Questins Questins regarding the prgram, including questins regarding this r ther funding pprtunities, shuld be directed t the Senir Manager fr Research. Tel: Web site: Help@Grants.rg (Rev 5/15/14) Instructins fr Applicants p.29/31

30 24. APPENDIX 1: DESCRIPTION OF RESEARCH AREAS In Tab 2 (Applicatin Infrmatin / Applicatin Classificatin) the Applicant is required t select a Research Area that best describes the prpsed wrk. Descriptins f Research Areas are as fllws: Cancer bilgy: Research n the bilgy f hw cancer starts and prgresses as well as nrmal bilgy relevant t these prcesses. Examples include ncgenes and suppressr genes, epigenetics, DNA repair, grwth factrs, signaling pathways, cancer immunlgy, micrenvirnment, tumr prgressin, and metastasis. Cancer cntrl, survivrship, and utcmes research: Research in this categry cvers a brad range f areas including patient care and pain management, cancer surveillance, cancer disparities research, quality f life fr patients with cancer and their families, identificatin and reductin f late effects f cancer treatment, educatin and cmmunicatins that reduce cancer risk, health services research, and attitudes and belief systems that affect cancer cntrl. Early detectin, diagnsis, and prgnsis: Identificatin and testing cancer markers and imaging methds detecting and/r diagnsing cancer as well as predicting the utcme r chance f recurrence. Examples include discvery f markers and/r technlgies fr use in cancer detectin and diagnsis and/r prgnsis, animal trials and clinical human trials, tumr respnse t therapy, risk assessment, screening methds, infrmatics and infrmatics netwrks, and bistatistics. Etilgy: Research n the causes f cancer genetic, envirnmental, and lifestyle factrs and their interactins. Examples include envirnmental chemicals, hrmnedisrupting agents, gene-envirnment interactins, micrbial agents, radiatin expsure, and genetic plymrphisms that affect carcingen metablism. Preventin: Identificatin f interventins that reduce cancer risk. Examples include chempreventin, vaccines t prevent cancer, behaviral mdificatins that reduce cancer risk, studies n energy balance and dietary factrs assciated with cancer risk, and identificatin f cancer risk factrs. (Rev 5/15/14) Instructins fr Applicants p.30/31

31 Scientific mdel systems: Develpment f new animal mdels, cell culture systems, and cmputer simulatins and their applicatin t ther studies acrss the spectrum f cancer research. Examples include mathematical mdeling f cancer prcesses; develpment f diverse animal mdels, including transgenic mice, zebrafish, Drsphila, etc.; and develpment f rgan and tissue mdel systems. Treatment: Identificatin, develpment, and testing f treatments fr cancer. Examples include drug develpment, immuntherapy, persnalized cancer therapy, methds f drug delivery, antiangigenic therapy, clinical trials, and treatments t prevent recurrence. 25. APPENDIX 2: PROGRAM FOCUS - DEFINITIONS OF CANCER RESEARCH TYPES In Tab 2 (Applicatin Infrmatin/Applicatin Classificatin), the Applicant is required t select a Prgram Fcus that best describes the prpsed cancer research type. Descriptins f Cancer Research Types are as fllws*: Basic Research - results in the acquisitin f new knwledge and elucidates fundamental mechanisms in bilgy. Translatinal Research - invlves the applicatin f discveries frm Basic Research t practical prblems assciated with cancer as well as research n hw t imprve best practices in the cmmunity. Clinical Research - invlves studies with human subjects and includes patientriented research n mechanisms f disease, therapy, and develpment f new technlgies as well as epidemilgic and behaviral studies and utcmes and health services research. *Taken frm, Rubi et. al., Defining Translatinal Research: Implicatins fr Training, Acad. Med. 85: , (Rev 5/15/14) Instructins fr Applicants p.31/31