Electronic Intake User Manual for Industry
Contents
1. Service Lab Subcontract Testing Workorder Select the type of contract you will be entering The information you will need to provide is determined on the type of contract Required and Optional Data Table Protocol or Workscope Data Use Agreement coayNDA TERR Registry R R R R o MTA O R R R R f Subcontract R R R R O O Testing R R R R O Service Lab R R R R S OO O R f e Contract Type Questionnaire Sponsor Contact Redline Contract CTA Master O R Workorder R R R R O Research RO JO R J R U R e Other O R R R o o R Required O Optional Blank Not Needed Page 6 Page 7 CDA Data Entry Contract Web ID 0 Uploaded File If the needed name does not appear when searching please contanct Sponsor Programs Administration SPAdmin for further assistance PT Name Search search Sore caus Project Title Sponsor Sponsor Contact Information Contat Type OC Sponsor O CRO First Name Submitted Search for the PI Name As you type a drop down of possible names will appear Select the appropriate name when it is available Note If the person is new to UNMC and does not appear Contact SPAdmin to have them added to the names list Page 8 Contract Web ID 0 Proposal Contract Upload Browse Uploaded File If the needed name does not appear when searching please co2. and Settings ccmill ff Uploaded File 35 08_Template_CTA doc o Uploaded File with icons at the end Contract Web ID 26 35 08_Template_CTA doc Icons Trash Can Delete the uploaded document M Paper View the uploaded document tf Click the for a summary sheet of the Contract Click the button to continue the data entry process Sponsored Programs Administration Contract Questionnaire Instructions The Sponsor Programs Asministration SPAdmin Contract Questionnaire is designed to be completed and signed by the principal investigator and is to accompany each contract submitted to Sponsored Programs Administration for negotiation Please include a copy of the study protocol a contact at the sponsor for contract negotiation and an electronic copy e g Word Document it cannot be a PDF of the proposal contract How Information Will Be Used Answers will guide Sponsored Programs Administration staff in negotiating contract terms and in establishing workable timelines Signatures will certify investigator compliance with FDA department regulations tudy Protocol Workscope U pload Uploaded Study Data Use Agreement Upload Protocol Workscope Uploaded Data Use Agreement Contract Web ID 26 Page 25 Time Line Information Timeline 1 What is the anticipated start date of this project Date Format mm dd yyyy 2 15 this a sponsor imposed start date Project Ty
3. indicators to know if you have completed the data entry process or not P indicates that all information is provided Required i Indicates if data entry is required before routing for signature Optional Indicates if data entry is optional and only applies in certain circumstances Go To Contract Principal Investigator Information Go To with a blue link 1s a link directy to the page where the data can be entered View the uploaded document link Page 13 Sponsored Programs Administration Contract Intake Summary Instructions The Sponsor Programs Asministration SPAdmin Contract Intake Process is designed to be completed and signed by the principal investigator and is to accompany each contract submitted to Sponsored Programs Administration for negotiation Please include a copy of the study protocol a contact at the sponsor for contract negotiation and an electronic copy e g Word Document it cannot be a PDF of the proposal contract How Information Will Be Used Answers will guide Sponsored Programs Administration staff in negotiating contract terms and in establishing workable timelines Signatures will certify investigator compliance with FDA department regulations Contract Web ID 24 Contract Type CDA NDA Title This is a sample title for a sample CDA for samples in training Items Required to Submit to Sponsored Programs Administration rincipal Investigator Required Go To Contract P
4. project O pi Sponsor PI 4 Who initiated this project PI O Sponsor 4a lf this is a Pl initiated clinical trial have you or do you intend to file an IND or seek IND exemption IND IND Exemption Page 27 Question 5 5 Who wrote the protocol O Sponsor D Investigator O Sponsor and Investigator Question 6 6 15 the study Multicenter Single Site Question 7 T What are the sources of funding that will be used to support this project LJ Sponsor LJ Other Question 8 8 What funding sources will be used to contribute to this work in the future Question 9 9 If you are receiving or have received federal funds for research are any O of the funds related to this project Yes No Question 10 No 10 Will this project require the use of non UNMC personnel for the Oves On conduct of the project es No Yes 10 Will this project require the use of non UNMC personnel for the conduct of the project Yes KANo contact information Confidentiality and Intellectual Property Question 1 No 1 Have you signed a confidentiality agreement CDA with the Sponsor O Yes E No that relates to this project e g has the Sponsor provided you with confidential information for your evaluation of the project that must be held in confidence under the terms of the CDA Yes 1 Have you signed a confidentiality agreement CDA with the Sponsor G Yes Cc No that relates to this pro
5. Electronic Intake User Manual for Industry Sponsored Contracts ADIS Entry Point What is ADIS ADIS stands for Academic Department Information System Use the following steps to gain access to ADIS Those using ADIS for the New Electronic Intake Process will need to contact Sponsored Programs Administration to be assigned appropriate security access for ADIS Note If you attended training sponsored by SPAdmin your security access has been set up Steps for ADIS Login Begin at UNMC s intranet home page info unmc edu W4 UNIVERSITY OF NEBRASKA MEDICAL CENTER C auick Links gt BOOKSTORE CAFE MENUS DIRECTORY Search O LOG IN go Resources for Students Faculty amp Staff Alumni UNMC TODAY UNMC S INTRANET Information for Students Faculty amp Staff Alumni Click on the Quick Links button and the following screen will appear Page 1 Quick Links 2007 2008 Campus Accomplishments Report General Supply Catalog Strategic Plan Hand Hygiene Detailed Plan Healthy U Chancellors Retreat IDs Passwords Planning Info amp Quality Indicators Jobs UNMC Prioritization of Academic Programs Library Academic Service Media guide for faculty amp staff Announcements NCA HLC reaccreditation process BlackBoard Online Courses Ombuds Team BookStore UNMC Policies Procedures Calendar of Events Physician Carecast Training Center for Clinical and Translational Research Printshop UNMC Center for Continuing Educat
6. No 5 lf this is a renewal or continuing project were any inventions previously O Yes E No conceived or reduced to practice Yes conceived or reduced to practice Please specify in detail Question 6 No 6 Do you have an invention disclosure patent filing or any IP agreement O Yes O No on file or pending with the IPO Yes 6 Do you have an invention disclosure patent filing or any IP agreement O Yes O Na on file or pending with the IPO Please specify in detail Question 7 T How likely is it that a new discovery invention process biological O O J P 3 O 4 O 5 material or research tool will result from your personal contribution or the contribution of other UNMC personnel on this project 1 Not at all likely 5 Highly Likely Question 8 8 Do you want to publish or use the research results on other projects Yes O No Page 31 Question 9 No 9 Will students be involved on the project O yes No Yes 9 Will students be involved on the project Yes O No Addresses need of students to publish Question 10 10 Are you willing to transfer ownership of all data resulting from the yes No study to the study sponsor Please explain Regulatory Affairs Question 1 No 1 Is an IRB required for this project Oves No Yes 1 15 an IRB required for this project yes O No la Has your protocol been submitted to the IRB Yes C No IRE Number e 1b Does this pro
7. _Template_CTA doc ye Protocol Workscope Required sSGN35 008_Protocol_AQ00 pdf a Data Use Agreement Optionay Go To Data Use Agreement Upload Submitted for Sianature By Submitted for Sianature on Route To PI Page 34 Help Indicators Signature page contains help indicators to know if you have completed the data entry process or not mA indicates that all information is provided Required s l Indicates if data entry is required before routing for signature Optional Indicates if data entry is optional and only applies in certain circumstances Co To Contract Principal Investigator Information Go To with a blue link is a link directory to the page where the data can be entered View the uploaded document link PI Signature Step is the same as outlined in the CDA Page 35 Sponsored Programs Administration Contract Intake Summary Instructions The Sponsor Programs Asministration SPAdmin Contract Intake Process is designed to be completed and signed by the principal investigator and is to accompany each contract submitted to Sponsored Programs Administration for negotiation Please include a copy of the study protocol a contact at the sponser for contract negotiation and an electronic copy e g Word Document it cannot be a PDF of the proposal contract How Information Will Be Used Answers will guide Sponsored Programs Administration staff in negotiating contract terms and in est
8. ablishing workable timelines Signatures will certify investigator compliance with FDA department regulations Contract Web ID 32 Contract Type CTA Tithe Sample Project Title Items Required to Submit to Sponsored Programs Administration x Principal Investigator Required Go To Contract Principal Investigator Information Miller Crystal x Sponsor Required Go To Contract Sponsor Information Novartis Pharma Inc x Contract Questionnaire Required Go To Contract Questionnaire A Sponsor Contact Required Co To Contract sponsor Contact Information A Redline Contract Required Go To Redline Contract Upload Sam ple Proposal Contract doc x Protocol Workscope Required Go To Protocol Workscope Upload Sam ple Study Protocol doc ia Data Use Agreement Optional Co To Data Use Agreement Upload sam ple Data Use Agreement doc Submitted for Sianature By Submitted for Sianature on Princi Inwestigator Certification CERTIFY THAT AM NOT UNDER INVESTICATION BY THE FDA FOR DEBARMENT ACTION OR PRESENTLY DEBARRED PURSUANT TO THE GENERIC DRUG ENFORCEMENT ACT OF 199 21 U S C 335 a AND b AS AMENDED FROM TIME TO TIME ADDITIONALLY REPRESENT THAT HAVE NOT BEEN DISQUALIFIED FROM PARTICIPATING IN A CLINICAL TRIAL PURSUANT TO 21 CFR 312 70 45 AMENDED FROM TIME TO TIME I certify the above statement is true Submitto SPA Page 36
9. contract it is essential to search for one that may already be in progress Use the screen below for that search Sponsored Programs Administration Contract Intake Search eee Web ID Sponsor Department Enter Last Name of the investigator for the broadest search for that investigator s projects Page 4 Contract Web ID Sponsor Tee 3 iee 2 Tee 21 Hee i5 Hee 16 Tee 18 Tee 19 iee 20 gee 22 Tee 23 fe e 5 Dee e 6 fe e B we e 2 te amp 7 Te e 3 14 Status Meanings Seattle Genetics Inc Quintiles Inc Accutek Testing Laboratory Accutek Testing Laboratory Nowartis Pharma Inc Quintiles Inc Pfizer Inc Pfizer Inc UNL Pfizer Inc NewLink Genetics Corporation Pfizer Inc Pfizer Inc Pfizer Inc NuwOx Pharma LLC Pfizer Inc Pfizer Inc Title New CDA for Deborah Vetter with Nowartis Sample Master This is a sample This is a sample CDA for Deborah CDA between Novartis and UNMC cda New COA Gobbledy Gook education k 12 Test Research Agreement Sample This is a sample contract To be assigned This is a special test contract Sample title This is a sample contract sample project Start Date Fl Name In Process Vetter Deborah Status In Process Wetter Deborah In Process Wetter Deborah 12 1 2009 12 1 2009 12 15 2009 12 31 2009 2 9 2010 12 1 2010 1 1 2009 In Route In Route In Route In Route In Route In Route In R
10. dmin for further assistance PI Name Search Seok Principal Investigator Vetter Deborah K Project Title Sponsor Sponsor Contact Information Contact Type O Sponsor O CRO Submitted Once selected the Principal Investigator s Home department will appear in the drop down box to the right of their name Ifthe contract will be administratively managed in the investigators home department leave it as the default Ifthe contract will be administratively managed in a department other than the investigators home department change the department to the department where the contract will be managed Page 19 Contract Web ID 0 Uploaded File If the needed name does not appear when searching please contact Sponsored Programs Administration SPAdmin for further assistance PI Name Search Benes Principal Investigator Vetter Deborah K Sponsored Programs Administration Project Title J Sponsor Sponsor Contact Information Contac Type Sponsor cro First Name Ps Last Name fs Submitted Save Questionnaire Enter the Project Title in the box provided Note The project title IRB title and Protocol title must match exactly Page 20 Contract Web ID 0 Uploaded File If the needed name does not appear when searching please contact Sponsored Programs Administration SPAdmin for further assistance PI Name Search Benes Principal Investigator Vetter D
11. eborah K Sponsored Programs Administration Project Title Sponsor Name Search Sponsor Sponsor Contact Information Contact Type O Sponsor O CRO Submitted Save Questionnaire Search for the Sponsor Use the Legal Entity that UNMC will be contracting with Note If the sponsor does not appear contact SPAdmin to add a new sponsor to the drop down list Page 21 Contract Web ID 0 Uploaded File If the needed name does not appear when searching please contact Sponsored Programs Administration SPAdmin for further assistance PI Name Search Benes Principal Investigator Vetter Deborah K Sponsored Programs Administration Project Title Sponsor CRO Name Search Search Sponser Contact Information Contact Type O Sponsor O CRO Submitted Questionnaire Search for the CRO Use the Legal Entity that UNMC will be contracting with Note If the CRO does not appear contact SPAdmin to add the new CRO to the drop down list Note Only use the legal entities that the CDA will be with so even if a CRO is involved but we are not contracting with them do not add them to the agreement at this point Page 22 Contract Web ID 0 Uploaded File If the needed name does not appear when searching please contact Sponsored Programs Administration SPAdmin for further assistance PI Name Search Benes Principal Investigator Vetter Deborah K Sponsored Programs Admin
12. ignature which indicates e All the information provided is true complete and accurate e Provide certification of non debarment Follow the instructions below to e Verify information for this contract e Provide your electronic signature for this agreement Copy https edge unmc edu adis index asp into your default browser Login using your Lotus Notes ID and Password 3 From the Navigation menu on the Left hand side of your screen click the symbol in front of the Research folder 4 Click the symbol in front of the Grants amp Contracts folder 5 Click Contract Intake 6 To verify and sign the current contract enter the number provided above into the Contract Web ID field 7 Click on the red book icon to review sign the contract Review the information by clicking on the blue links 9 If all information provided is true complete and accurate provide your electronic signature by clicking the box labeled I certify the above statement is true 10 Finalize the contract by clicking the Submit to SPA button NO i Page 15 Sponsored Programs Administration Contract Intake Summary Instructions The Sponsor Programs Asministration SPAdmin Contract Intake Process is designed to be completed and signed by the principal investigator and is to accompany each contract submitted to Sponsored Programs Administration for negotiation Please include a copy of the study protocol a contact at the sponsor for contract
13. ion Room Scheduling Center for Healthy Living RSS Research Support Systems Children s Hospital Affiliation Software Downloads Compliance Sponsored Programs Administration Access to Training Story Ideas Clinical Research Billing Student Senate Conflict of Interest The Nebraska Medical Center Record Retention The Nebraska Medical Center Intranet DRC website Travel Services Employee Self Service Med Center UNeMed Intellectual Property and Technology Transfer Employee Self Service SAP UNMC Physicians Employee Students Discount Program UNMC Physicians Intranet Events Center Viruses Current Computer Virus Threats Faculty Senate WebOncall Firefly WebOncall Tutorial Click on the ADIS link and the following screen will appear UNMC CONTACT US DIRECTORY gt Information for Students Faculty amp Staff UNIVERSITY OF NEBRASKA MEDICAL CENTER Information Technology Services ADIS Academic Department Information System Enter your UNMC NetID and password in the spaces provided below and click the Continue button Enter your UNMC NetID help Enter your password emme LOG IN TY Copyright 2009 University of Nebraska Medical Center Blackboard 42nd and Emile Omaha NE 68198 e 402 559 4000 UNMC Intranet Medical Center University Computer Use Policy Copyright Violations pre ee Notice of Privacy Practice Library Enter your Lotus Notes user name and pass word to ender the ADIS applicati
14. istration Project Title Sponsor Contact Type Ci Sponsor O CRO Submitted Save Questionnaire Enter the Sponsor Contact Information First Name Last Name Email Phone Number Is the contact with the Sponsor or the CRO Check the appropriate one Note This is the person the SPA negotiator is to contact to negotiate the contract not the site administrator or a scientific contact You can Save the Contract at this point Page 23 Proposal Contract Upload Contract Web ID 0 Proposal Contract Upload Uploader fih If the needed name does not appear when searching please contact Sponsored Programs Administration SPAdmin for further assistance PI Name Search me Principal Investigator Vetter Deborah K Project Title Sponsor cro ifappicable o O Sponsor Contact Information Contact Type O Sponsor O CRO First Name Submitted Save Print Questionnaire Upload the Contract document Click the button and look for the file where you have it stored Note Must be in a Word or an RTF format An error messa Click the button to complete the data entry process Note The data can be saved without the document upload but cannot be submitted for signature Page 24 Two identifiers are added to know that the file is saved o Contract Web ID Number a unique identifier Proposal Contract Upload C Documents
15. ject e g has the Sponsor provided you with confidential information for your evaluation of the project that must be held in confidence under the terms of the CDA Please specify in detail e g effective date of CDA Detail and effective date of CDA Question 2 No 2 Have you signed a material transfer agreement MTA with the Sponsor C Yes O No that relates to this project e g has the Sponsor provided you with materials for your evaluation of the project that must be held in confidence under the terms of the MTA Yes 2 Have you signed a material transfer agreement MTA with the Sponsor O Yes O No that relates to this project e g has the Sponsor provided you with materials for your evaluation of the project that must be held in confidence under the terms of the MTA Please specify in detail e g effective date of MTA Page 29 Question 3 No 3 Outside of this study have you signed a consulting agreement for O Yes No which this science or technology is the subject Yes 3 Outside of this study have you signed a consulting agreement for O Yes O No which this science or technology is the subject Please specify Question 4 No 4 Are there drugs or devices that are being provided by someone other O Yes No than the sponsor Yes 4 Are there drugs or devices that are being provided by someone other Yes O No than the sponsor Please specify Page 30 Question 5
16. ject include children as human subjects O yes No 1c ls there a time for recruitment of human subjects after which the Yes C No sponsor will unilaterally terminate the contract if none have been enrolled Weeks Months Cut off date Date Format mm dd ww Note If No to la then no IRB number is required Note If No to Ic then cut off dates are not required Page 32 Question 2 No 2 Will animals be used on this project Oves No Yes 2 Will animals be used on this project yes No 2a Has your protocol been submitted to the JACUC Yes CO No IACUC Number f Note If No to 2a then no ACUC number is required Question 3 No 3 Does your research use recombinant DNA and or microbiological 7 _ l Oves No agents in any assay Yes 3 Does your research use recombinant DNA and or microbiological ne ae yes O No agents in any assay 3a Are your experiments covered by the NIH Guidelines for Research Involving Recombinant DNA Molecule Refer to section Il of the Wes O No Guidelines available as a resource on the IBC website 3b Has your protocol been submitted to the IEC O Yes C No BC Number Note If No to 3b then no IBC number is required Page 33 Click the button to save all data entered in the contract questionnaire Note If questions are answered incorrectly error messages will appear telling which question is not answered Windows Internet Ex
17. negotiation and an electronic copy eg Word Document it cannot be a PDF of the proposal contract How Information Will Be Used Answers will guide Sponsored Programs Administration staff in negotiating contract terms and in establishing workable timelines Signatures will certify investigator compliance with FDA department regulations Contract Web ID 25 Contract Type CDA NDA Title Test froma Pl perspective Items Required to Submit to Sponsored Programs Administration lw Principal Investigator Required Go To Contract Principal Investigator Information Miller Crystal C i Sponsor Required Go To Contract Sponsor Information Novartis Pharma Inc jt Sponsor Contact Required Go To Contract Sponsor Contact Information a Redline Contract Required Go To Redline Contract Upload NDA University of Nebraska Medical Center0909 v1 Submitted for Sianature By Submitted for Signature on CERTIFY THAT AM NOT UNDER INVESTIGATION BY THE FDA FOR DEBARMENT ACTION OR PRESENTLY DEBARRED PURSUANT TO THE GENERIC DRUG ENFORCEMENT ACT OF 199 21 USC 335 a AND b AS AMENDED FROM TIME TO TIME ADDITIONALLY REPRESENT THAT HAVE NOT BEEN DISQUALIFIED FROM PARTICIPATING IN A CLINICAL TRIAL PURSUANT TO 21 CFR 312 70 AS AMENDED FROM TIME TO TIME When the Principal investigator checks the box this provides the electronic signature and verification for the current agreement Submitta SPA The final step i
18. ntact Type C Sponsor O CRO First Name Submitted Route For Signature Upload the CDA contract document Click the HErewse button and look for the file where you have it stored Note Must be in a Word or an RTF format An error message will appear if you try to upload different file types Windows Internet Explorer a n editable Proposal Contract must be uploaded Please correct before continuing Note PDF or non editable copies are not allowed Click the button to complete the data entry process Note The data can be saved without the document upload but cannot be submitted for signature Two identifiers are added to know that the file is saved o Contract Web ID Number a unique identifier Page 12 Browse Uploaded File NDA University of Nebraska Medical Center0909 1 Doc 3 Proposal Contract Upload E Cintake Training NDA Univers o Uploaded File with icons at the end Contract Web ID 24 Proposal Contract Upload E Cintake Training NDA Univers ed Fili NDA University of Nebraska Medical Center0909 1 boc H Icons Trash Can Delete the uploaded document f z Paper View the uploaded document W Click the n for a summary sheet of the CDA Route For Signature Click the to move to the Summary Page and proceed with routing to the Principal Investigator for signature Help Indicators Signature page contains help
19. ntanct Sponsor Proqrams Administration SPAdmin for further assistance PI Name Search Principal Investigator b Project Title 2 Sponsor Name Search Search Sponsor CRO if applicable CRO Name Search Sponsor Contact Information Contact Type O Sponsor CRO First Name Last Name Email Phone Submitted Enter the project title CDAs may be titled with Protocol title or a title that easily identifies the study Contract Web ID 0 Uploaded File If the needed name does not appear when searching please contanct Sponsor Programs Administration SPAdmin for further assistance PI Name Search Principal Investigator a Project Title ponsor Name Search Sponsor CRO Name Search Seth CRO if applicable PO Sponsor Contact Information Contact Type O Sponsor O CRO First Name Last Name Phone Submitted Search for the Sponsor Use the Legal Entity that UNMC will be contracting with Note If the sponsor does not appear contact SPAdmin to add a new sponsor to the drop down list Page 9 Contract Web ID 0 Uploaded File If the needed name does not appear when searching please contanct Sponsor Programs Administration SPAdmin for further assistance Project Title Sponsor CRO Name Search Search Sponsor Contact Informa
20. on and click continue Navigation of the ADIS web site Page 2 For navigation use the navigation tree on the left hand side of the screen open all close all home iw align out ve Q Search for People Print Page B Mailing Labels e My Favorites T Admin Auth H User Documentation Click on the sign in front of the research folder open all close all home a ADIS gl Sign out a Q search for People Print Page E Mailing Labels Hg My Favorites of Admin Auth H Personnel Record Bey Research i Biosketch ais aa Research Interest Survey a Q Search Publications H Centers amp Programs _ Grants amp Contracts H Publication B Study Sections H Reporta H 2 User Documentation Click on the sign in front of the grants amp contracts folder dmintetration Page 3 open all close all home of ADIS ok Sign out pen Q Search for People ane so Print Page Mailing Labels 2 a wf My Favorites f Admin Auth i _ Personnel Record A Research Biosketch a Research Interest Survey a Q Search Publications eH mp Centers amp Programs 5 ra Grants amp Contracts E ii Publication Administration E Study Sections a LE Reports E User Documentation Click on the Contract Intake button Begin Contract Intake Data Entry Contract Intake Search appears Before you can enter a new
21. oute In Route In Route In Route In Route In Route In Route Wetter Deborah Wetter Deborah Wetter Deborah Wetter Deborah Wetter Deborah Wetter Joshua Wetter Deborah Vetter Deborah Vetter Deborah Vetter Deborah Wetter Deborah Wetter Deborah Wetter Deborah Submitted Wetter Deborah In Process Contracts that you have entered part of the information has not been submitted to PI for signature In Route Submitted to PI for signature but not signed by PI Submitted Signed by PI and submitted to SPA for processing Icons Meanings e Trashcan Delete i e Green Book Edit General Contract Information it e e Paper View Edit Questionnaire te Red Book Edit View Contract Summary Other Search Functions Sponsored Programs Administration Contract Intake Search Last Mame First Name Department Contract Web ID Unique Identifier creates a quick search Page 5 Sponsored Programs Administration Contract Intake Search Last Name First Mame Department 2 Search Rese Sponsor Search by sponsor or check the CRO checkbox to the right and search by CRO If contract is not already started click the button It does not appear until you have done an initial search Contract General Information Please select the tvoe of contract beina entered CDA NDA CTA O MTA O Master OD Other Registry Research
22. pe Information Question 1 Project Type 1 15 this project a clinical trial Yes 1 15 this project a clinical trial la Please indicate the study phase 1b Please identify the study participants lc Please provide the name of the Nurse Coordinator or other staff member to whom SPA may direct any project related questions Contact Name Contact Email No la If this is not a Clinical Trial how would you describe it Testing LI Laboratory Research CI Registry C Other Describe E Yes O No O Yes No Yes O No LJ Phase L Phase LJ Phase Phase Il IV al Compassionate Use Inpatient O Outpatient Both Inpatient and Outpatient Contact Phone Page 26 Question 2 2 Please identify the location of the study facilities to be used and C UNMC NMC appropriate contact information for all non UNMC parties involved with this project dl VA Fi Children s Hospital L Creighton Uniwersity Medical Center Correr pesse sea ooi G i i Name phone number Question 3 No 3 Has this project been listed in a clinical trials registry O Yes No Yes 3 Has this project been listed in a clinical trials registry Yes No ee ee oe O Principal Investigator O Sponsor O Other please speci Oooo 3b Please indicate the Registry EN ClinicalTria leas Address http www ClinicalT rials gov gevicsaton umber SY Question 4 Sponsor 4 Who initiated this
23. plorer When the questionnaire is finalized and will save you can click the button to geta hard copy of the questionnaire Click the Submit for signature button to move to the Contract Intake Summary Page Sponsored Programs Administration Contract Intake Summary Instructions The Sponsored Programs Administration SPAdmin Contract Intake Process is designed to be completed and signed by the principal investigator and is to accompany each contract submitted to Sponsored Programs Administration for negotiation Please include a copy of the study protocol a contact at the sponsor for contract negotiation and an electronic copy e g Word Document it cannot be a PDF of the proposal contract How Information Will Be Used Answers will guide Sponsored Programs Administration staff in negotiating contract terms and in establishing workable timelines Signatures will certify investigator compliance with FDA department regulations Contract Web ID 26 Contract Type CTA Title This is a sample proposal Items Required to Submit to Sponsored Programs Administration a Principal Investigator Required Go To Contract Principal Investigator Information Vetter Deborah K A Sponsor Required Novartis Pharma Inc al Contract Questionnaire Required Go To Contract Questionnaire ye Sponsor Contact Required Co To Contract Sponsor Contact Information Ie Redline Contract Required Go To Redline Contract Upload 35 08
24. rincipal Investigator Information Vetter Deborah K a Sponsor Required Go To Contract Sponsor Information NovaRx Corporation rd Sponsor Contact Required A Redline Contract Required Go To Redline Contract Upload IDA University of Nebraska Medical Center0909 v1 Submitted for Sianature By Submitted for Sianature on Route To Pl d Required nt If all the fields are not then the agreement is not complete and cannot be forwarded to the PI for signature or to SPAdmin for negotiation When all fields are not complete the following message will appear as an error Corrections will need to be made before the contract can be routed to the PI for signature Windows Internet Explorer A 4 Redline Contract is Required and has not been uploaded Please correct before continuing Required F When all fields are completed and all fields have a then the contract can be routed to the PI for signature Page 14 PI Signature step The PI will receive an email from the administrator or coordinator who is completed the online Contract Intake information which provides them with Sample Email Your electronic signature is required for negotiation to begin on the following agreement entered by Administrator Coordinator Name Contract Web ID i Sponsor Novartis Title This is a sample Please log into ADIS to review verify the documents provided and to provide your electronic s
25. s for the Principal Investigator to check the button Checking this button sends a notification to SPAdmin that there is a contract to process and begin negotiation Page 16 CTA Data Entry Contract Type Questionnaire Sponsor Contact ct Protocol or Workscope Data Apreement Redline Contract CTA gt oN eo lt gt SO lt gt N o re ee ee O T G CDA NDA Registry MTA Subcontract Testing Service Lab Master Workorder Research Other R Required O Optional Blank Not Needed Please select the tvoe of contract beina entered O CDA NDA CTA O MTA Master Other O Registry C Research E Service Lab O Subcontract Testing C Workorder Select CTA and the General Contract Information screen will appear Page 17 Contract Web ID 0 Uploaded File If the needed name does not appear when searching please contact Sponsored Programs Administration SPAdmin for further assistance Game sea Seach Project Title L 3a wows OOOO ooo E Sponsor Contact Information Contact Type D Sponsor oC CRO First Name p Fd as phones iS Submitted Save Questionnaire Search for the Principal Investigators by last name and select from the drop down that appears to the right of the Name search box Page 18 Contract Web ID 0 Uploaded File If the needed name does not appear when searching please contact Sponsored Programs Administration SPA
26. tion Contact Type O Sponsor O CRO First Name Submitted Route For Signature Search for the CRO Use the Legal Entity that UNMC will be contracting with Note If the CRO does not appear contact SPAdmin to add the new CRO to the drop down list Note Only use the legal entities that the CDA will be with so even if a CRO is involved but we are not contracting with them do not add them to the agreement at this point Page 10 Contract Web ID 0 Uploaded File If the needed name does not appear when searching please contanct Sponsor Programs Administration SPAdmin for further assistance PINameSearch Sach Project Title Sponsor Sponsor Contact Information Contact Type OO Sponsor D CRO First Name Submitted Enter the Sponsor Contact Information First Name Last Name Email Phone Number Is the contact with the Sponsor or the CRO Check the appropriate one Note This is the person the SPA negotiator is to contact to negotiate the contract not the site administrator or a scientific contact Page 11 Contract Web ID 0 Da Brows Proposal Contract Upload Uploaded File If the needed name does not appear when searching please contanct Sponsor Programs Administration SPAdmin for further assistance Project Title Sponsor Name Sesrch Search Sponsor CRo name search __ Search CRo Gif applicable o Sponsor Contact Information Co
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