Investigator-Initiated Research. Full Instructions Submission Website

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Agnes Gilbert
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1 Investigator-Initiated Research Full Instructions Submission Website

2 TABLE OF CONTENTS Submission Form Functionality... 4 Completing Text Fields...4 Fields with Character Limitations...4 Multi-Select Data Fields...5 Attaching Documents...6 Submission Form Navigation... 7 Organization...7 Navigation Buttons...7 Required Fields...8 Error Messages...9 Submit Final...10 Submission Form Details General Information Section...11 Concept Full Grant Request Section...12 Drug Request Section...12 Funding Request Section...12 Outside Support...12 Study Details Section...13 Research Timing/Progress Section...13 Study Deliverables Section...13 Legal, Safety and Regulatory Section...14 Pfizer SAE Reporting Policy (for human studies involving Pfizer drug)...14 Government Official Identification Section...15 Foreign Corrupt Practices Act (FCPA) - Potentially Influencing Government Official (PIGO) /3/ of 22

3 Primary Site Information...16 Principal Investigator Name...16 Principal Investigator Mailing Address...16 Principal Investigator Organization...16 Primary Correspondence Contact / Site Contact Information...17 Site Coordinator...17 Contracting Organization...18 Contracting Organization Contact...18 Updates and Files...18 Document Requirements...18 Website Information...19 Home Page...19 Grant Statuses...20 Draft...20 Completed...20 Submitted...20 Under Review...20 Interest...20 Declined...20 Withdrawn...20 Approved...20 Ongoing...20 Terminated...20 Closed...20 Website Data Privacy Statement...21 IIR Submission Confidentiality Policy...21 Getting Assistance...21 Table of Figures /3/ of 22

4 Submission Form Functionality Completing Text Fields All text fields must be entered in English. The following are considered special characters and will cause an error message # $ % ^ & * ( ) _ + = : < > \ Note: The information provided via the submission form should be brief but relevant. Additional supporting documentation can be attached to your submission as appropriate (see section on Adding Documents) Fields with Character Limitations Study Title Study Synopsis Study Rationale Primary Endpoints Secondary Endpoints Statistical Methods Inclusion Criteria Exclusion Criteria Rational for Power Calculation Treatment Schedule or Dosing Regimen 110 Character Limit 1000 Character Limit 1000 Character Limit 1000 Character Limit 1000 Character Limit 1000 Character Limit 250 Character Limit 250 Character Limit 1000 Character Limit 1000 Character Limit 110 Character Limit This is one-hundred and ten characters including spaces. This is one-hundred and ten characters including spac 250 Character Limit This is two-hundred and fifty characters including spaces. This is two-hundred and fifty characters including spaces. This is two-hundred and fifty characters including spaces. This is two-hundred and fifty characters including spaces. This is two-h 1000 Character Limit This is one-thousand characters including spaces. This is one-thousand characters including spaces. This is one-thousand characters including spaces. This is one-thousand characters including spaces. This is onethousand characters including spaces. This is one-thousand characters including spaces. This is onethousand characters including spaces. This is one-thousand characters including spaces. This is onethousand characters including spaces. This is one-thousand characters including spaces. This is onethousand characters including spaces. This is one-thousand characters including spaces. This is onethousand characters including spaces. This is one-thousand characters including spaces. This is onethousand characters including spaces. This is one-thousand characters including spaces. This is onethousand characters including spaces. This is one-thousand characters including spaces. This is onethousand characters including spaces. This is one-thousand characters including spaces. 2/3/ of 22

5 Multi-Select Data Fields Fields where more than one option is available will be indicated by an icon with an arrow Insert Additional Item (see figure below). Figure 1 Multi-Select Data Fields Add To remove an additional item select arrow on the left of the row you would like to remove and press Ctrl + D on your keyboard. Figure 2 Multi-Select Data Fields Remove 2/3/ of 22

Attaching Documents Attachments can be uploaded one

To identify what type of document is being provided

For steps to upload documents please see figures

Figure 3 Click to attach file Figure 4 Browse

Select File Folder category from dropdown list

6 Attaching Documents Attachments can be uploaded one at a time. To identify what type of document is being provided a File Folder Category must be assigned. For steps to upload documents please see figures below. Figure 3 Click to attach file Figure 4 Browse computer for document and click Upload Figure 5 Select File Folder category from dropdown list Figure 6 To add additional documents Select Insert Additional Item Figure 7 To view, change or remove document select icon to the left of the attachment 2/3/ of 22

7 Submission Form Navigation Organization The IIR Submission Form is comprised of 6 Pages. The current page text will be in bold. (please see figure below) Figure 8 Submission form headers Navigation Buttons A submitter may choose to Save a Draft of their application prior to final submission to Pfizer. Selecting the Save As Draft button will record any changes to the submission form and return the submitter to the Home Page. The Submission Form will remain editable until the status is Submitted. (For information on Grant Statuses see page 19) To return to the Home Page without saving new information select the Cancel button. The form will only advance to the Next page once all of the required fields have been completed without error. (For information on Error Messages see page 8) A user may return to previously completed pages by using the Previous button. The full Instructions document is always accessible via a hyperlink at the bottom of each page. Figure 9 Navigation Buttons located at the bottom of each page 2/3/ of 22

8 Required Fields Required fields will be indicated in Red either with an asterisk ( ) or with a box Figure 10 Required Field Indicators 2/3/ of 22

9 Error Messages If the submitter has made an error on the current page of the submission form a new window will open with a Warning (see figure 11). To correct the error and resume filling out the form, the user should select Show Error Details and the field that is problematic will be listed (see figure 12). The error may be that a required field has not been completed, invalid characters were entered or too many characters were entered. Then select Continue to return to the submission form. Figure 11 Error Message Figure 12 Error Message Details 2/3/ of 22

Submit Final When all of the required fields have been completed and the appropriate documents have been uploaded the submission is ready to be sent to Pfizer (see figure

address. The Submission status will be Completed.

10 Submit Final When all of the required fields have been completed and the appropriate documents have been uploaded the submission is ready to be sent to Pfizer (see figure 13). Once the Submit Final button is selected a Confirmation Window will appear and a Confirmation (see figure 14) will be sent to the Principal Investigator address. The Submission status will be Completed. (For information on Grant Statuses see page 19) Figure 13 Submit Final Figure 14 Submission Complete Confirmations Confirmation Window Confirmation retransmit any information, text or documents contained in this Web site or any portion back thereof to Table in of any Contents 2/3/ of 22

11 Submission Form Details General Information Section External Identification Number* *For investigator/site identification purposes Primary Pfizer Therapeutic Area* (select from drop down list) *Please select the Pfizer Therapeutic Area most relevant to your research. This will ensure that the appropriate group at Pfizer reviews this request. Secondary Pfizer Therapeutic Area* (multi-select drop down list) *Choose one or more as applicable. Complete this field if your research spans more than one Pfizer Therapeutic Area. Submission Type* (select from drop down list) Concept Full *A concept submission must contain an adequate amount of information in order for Pfizer to determine interest in receiving a full proposal. *A full submission must contain enough detail about the research study and the grant request to enable Pfizer to make a final evaluation regarding support. For additional details see Investigator Initiated Research Program Information located at Study Type* (select from drop down list) Pre-clinical Clinical *Additional fields will result based on your selection. Example: Pre-clinical type: In vivo or In vitro Grant Request Type* (multi-select drop down list) Drug Funding Funding and Drug Other *Additional fields will result based on your selection. Example: Primary Pfizer Drug (alphabetic list of Pfizer products by generic name) Research Setting* (select from drop down list) Single-site Multi-site *Additional fields will result based on your selection. Examples: Number of sites and Other countries. Country of Primary Site (select from drop down list) The list of countries is in alphabetical order. Select the first letter in the country name to quickly navigate through the list. noncommercial individual reference with all copyright or other proprietary notices back retained, to Table of and Contents 2/3/ of 22

12 Grant Request Section Drug Request Section Drug Type (select from drop down list) Pure-substance (not for human use) Clinical (for blinded studies) Commercial Finished Goods Table or Pure Substance Table* (multi-select dropdown list) Generic Drug Name Strength (if applicable) Media i.e. capsule, tablet, injection (if applicable) Quantity Quantity of Placebo (if applicable) *Required for full submissions only when drug is requested. Funding Request Section Funding Local Currency (select from dropdown list) Total Funding Requested (full amount requested from Pfizer) Direct Labor Costs Subtotal* Direct Study Costs Subtotal* Institutional Overhead Subtotal* Institutional Overhead % (calculated by system) Indirect Costs Subtotal* *Required for full submissions only when funding is requested. Outside Support Non Pfizer Support for research (if applicable) Non Pfizer Drugs used in the study (if applicable) Note: Do not use currency symbols or commas when entering numerical figures as this will cause an error. Example: = ten thousand and = one hundred thousand. Direct Labor, Direct Study, Institutional Overhead and Indirect Costs should be equal to the Total Funding Requested. 2/3/ of 22

13 Study Details Section Study Title (Preliminary) Study Synopsis Study Rationale Type of Clinical or Pre-Clinical Study Are human tissue samples used Type and number of research animals Identification if Pfizer drug is applied on or off locally approved label Study Phase Cancer Type Cancer Setting Treatment Setting Primary and Secondary Endpoints Statistical Methods Inclusion of Pharmacokinetics Inclusion and Exclusion Criteria Study Design Target Subject Enrollment Rationale for Power Calculation Treatment Plan or Dosing Regimen Gender Age Group Ethnicity Note: Above is a list of potential fields in this section. Only applicable fields will be visible based on entries in the General Section. This is a dynamic form and additional fields may appear as applicable based on previous answers in this section. Research Timing/Progress Section Study Duration - in months (include any follow-up period if applicable) Target Study Start Date Target Date for First Subject First Visit Target Date for Last Subject First Visit Study Deliverables Section Target Date to Provide Results to Pfizer Plan to Publish? Result Type (dropdown list) Target Conference or Journal Target Date Notes above, you may not otherwise copy, display, download, distribute, modify, reproduce, back republish to Table of Contents or 2/3/ of 22

14 Legal, Safety and Regulatory Section Has the Principal Investigator previously participated in Investigator Initiated Research studies? Has the Principal Investigator previously participated in Investigator Initiated Research through Pfizer? Principal Investigator agrees to assume all legal & regulatory responsibilities as the sponsor. Principal Investigator agrees to sub-contract with other sites* Principal Investigator agrees to distribute drug to all sites* Principal investigator agrees to act as the coordinating Investigator* *If multi-site study Pfizer SAE Reporting Policy (for human studies involving Pfizer drug) For all IIR studies using a Pfizer Product and/or Device: Pfizer requires that, within 24 hours of first awareness of the event (or immediately if the event is fatal or life-threatening), the principal investigator will report to Pfizer by facsimile any Serious Adverse Event (SAE) that occurs during the SAE reporting period in a study subject assigned to receive the Pfizer product. In addition, for studies using a Pfizer device or Pfizer product packaged with a device, reportable events include not only SAEs but also Device Incidents and Device Near-Incidents. Reporting Forms: The principal investigator will report such SAEs using the Pfizer IIR SAE reporting form or the approved local regulatory form (i.e. FDA MEDWATCH form, CIOMS, etc.) and the Reportable Event Fax Cover Sheet provided by Pfizer. SAEs should be reported as soon as they are determined to meet the definition, even if complete information is not yet available. Reporting Period: The Reportable Events that are subject to this provision are those that occur from after the first dose of the Pfizer product through 28 days after discontinuation of the Pfizer product. Follow-up Information: The institution and/or principal investigator will assist Pfizer in investigating any SAE and will provide any follow-up information reasonably requested by Pfizer. Regulatory Reporting: Reporting an SAE to Pfizer does not relieve the institution and/or principal investigator of the responsibility for reporting it to the FDA or local regulatory authority, as required. Principal Investigator agrees to the terms of the Pfizer SAE Reporting Policy 2/3/ of 22

15 Government Official Identification Section Pfizer is committed to full transparency and due diligence around all financial interactions with healthcare professionals, their institutions and related organizations to further ensure and demonstrate the legitimate and invaluable purpose of such interactions. With respect to your request for support, Pfizer is required to make a factual determination of whether you are presently in a position to potentially influence a decision to approve, reimburse or purchase a Pfizer product, or influence an official act that would benefit Pfizer's business. It is for this reason we ask that you complete the list of questions below to the best of your and/or your organization's knowledge adhering to the spirit and letter of all applicable country and international laws and agreements. This is critical not only to satisfy applicable legal requirements and restrictions governing such interactions, but also to ensure their integrity and in turn to earn and maintain the trust of the patients, their families and caregivers as well as all other constituencies of the healthcare system that we serve. In doing so, this protects Pfizer as well as you and your organization. Is the Principal Investigator an elected or appointed government official at the National, Regional or Local level? Is the Principal Investigator employed by a National, Regional or Local Government Department? Is the Principal Investigator performing a governmental function on behalf of National, Regional or Local Government? Is the Principal Investigator acting on behalf of or an employee of a public or international organization or other publicly funded organization (i.e., UN, IMF, WHO, etc.)? Note: If the answer is yes to any of the above questions and the investigator is located outside of the United States or Puerto Rico the following questions will also apply: Foreign Corrupt Practices Act (FCPA) - Potentially Influencing Government Official (PIGO) Is the Principal Investigator, or anyone in the benefiting organization or institution, acting in a significant capacity (e.g., officer, director, founder, board member or any other member of leadership) or in a position to influence the following in their local market: the grant, amendment, variation, suspension, revocation or cancellation of a marketing authorization (product license) for a Pfizer product or other significant regulatory action? the conditions under which Pfizer products are marketed, distributed or sold? the granting of a permit or license which Pfizer needs to conduct its business? the price and/or reimbursement of a Pfizer product or formulary listing for a Pfizer product? other matters which may significantly affect Pfizer's business or products? (e.g., clinical trial approvals) thereafter may not be recopied, reproduced or otherwise redistributed. Except as expressly back to Table provided of Contents 2/3/ of 22

16 Primary Site Information Principal Investigator Name Investigator Title Investigator Salutation (select from dropdown list) Investigator First Name Investigator Middle Name Investigator Last Name Investigator Suffix Investigator Degree Principal Investigator Mailing Address Investigator Address Line 1 Investigator Address Line 2 Investigator Address City Investigator Address State (or Provence) Investigator Address Postal Code Investigator Address Country (select from dropdown list) Investigator Work Phone Investigator Fax Investigator (preferable method of communication) Investigator Pager Principal Investigator Organization Investigator Organization Name Investigator Organization Address Line 1 Investigator Organization Address Line 2 Investigator Organization City Investigator Organization State (or Provence) Investigator Organization Postal Code Investigator Organization Country (select from dropdown list) Note: Principal Investigator, Principal Investigator Mailing Address and Principal Investigator Organization will be pre-populated with information from the submitter s profile. However the information can be updated in the event a third party is submitting on behalf of an investigator Pfizer Inc. The contents of Pfizer Web sites may not be copied back other to Table than of for Contents 2/3/ of 22

Primary Correspondence Contact / Site Contact Information Please select the primary correspondence contact (select from dropdown list) Same

notification of grant status, requests for study updates and safety line listings. Site Coordinator Do you have a site coordinator?

17 Primary Correspondence Contact / Site Contact Information Please select the primary correspondence contact (select from dropdown list) Same address fields as Principal Investigator Figure 15 Primary Correspondence Contact Options Note: Primary Correspondence Contact will receive notification of grant status, requests for study updates and safety line listings. Site Coordinator Do you have a site coordinator? Site Contact Name: Site Contact Role (select from dropdown list) Site Contact Phone Site Contact Site Contact Fax Figure 16 Site Contact Role 2/3/ of 22

Contracting Organization Contracting Organization Type (select from dropdown list) Is the contracting organization the same as the investigator organization?

18 Contracting Organization Contracting Organization Type (select from dropdown list) Is the contracting organization the same as the investigator organization? Same address fields as Investigator Organization Figure 17 Contracting Organization Type Contracting Organization Contact Same address fields as Primary Correspondence Contact Updates and Files Document Requirements The following documents are required upon submission: Concept Submission Principal Investigator Curriculum Vitae Full Submission Principal Investigator Curriculum Vitae Itemized Budget (if funding support requested) Additional documents may be submitted as appropriate 2/3/ of 22

19 Website Information Home Page Figure 18 IIR Submission Website Home Page 2/3/ of 22

20 Grant Statuses Draft On the Home Page listed under My Draft IIR Project(s) are grant requests that have not yet been submitted to Pfizer. All information can be edited and updated. Completed On the Home Page listed under My Submitted IIR Project(s) are grant request that have been submitted to Pfizer but have not yet been transferred to Pfizer s internal management system. Files are transferred from the website approximately every 4 hours. All information can be edited and updated. Submitted On the Home Page listed under My Submitted IIR Project(s) are grant requests that have been transferred and are being reviewed for completeness and accuracy in preparation for evaluation. This is expected to take no more than 5-7 business days from the Submitted Status Date. Under Review On the Home Page listed under My Submitted IIR Project(s) are grants that are actively under evaluation by Pfizer. They will remain in this status until a final decision is made to Approve or Decline support. Interest On the Home Page listed under My In-Active IIR Project(s) are concept submissions that Pfizer is interested in receiving a full proposal. Declined On the Home Page listed under My In-Active IIR Project(s) are grant requests that Pfizer is unable to support. Withdrawn On the Home Page listed under My In-Active IIR Project(s) are grant requests that have been removed from consideration by the investigator or by Pfizer. Approved On the Home Page listed under My Active IIR Project(s) are full submissions that Pfizer has agreed to support. They will remain in this status until all required legal, regulatory and ethics documentation have been appropriately received by Pfizer. Ongoing On the Home Page listed under My Active IIR Project(s) are studies that have received the initial support from Pfizer as indicated in the executed contract. They will remain in this status until the study is completed and all appropriate closure documentation is received. Terminated On the Home Page listed under My In-Active IIR Project(s) are projects where the status reflects that a contract has been executed and support has been discontinued. Closed On the Home Page listed under My In-Active IIR Project(s) are project where the status reflects that all deliverables have been received as well as any required closure documentation. Copyrights. The entire contents of this Web site are subject to copyright protection. back Copyright to Table of Contents 2/3/ of 22

21 Website Data Privacy Statement When you register on this website the information you provide and associated personal data are collected by Pfizer Inc ( Pfizer ) in the United States, a country whose privacy laws may not provide equivalent protection for personal data to those in your home country. Pfizer will process your personal data for the purposes of evaluating your submission and administering any resultant ongoing relationship with you, and otherwise in accordance with the Pfizer Privacy Policy By clicking the next button below, you confirm your agreement to this processing by Pfizer of your personal data and to the terms of the Pfizer IIR Submission Policy. Pfizer Privacy Policy IIR Submission Confidentiality Policy All materials submitted must be non-confidential and should not contain any markings indicating confidentiality. By submitting your materials to Pfizer for review, you understand that we will not treat the information as confidential or proprietary. It is necessary to refer a submission to a number of different persons in the Company to ascertain whether or not a research proposal is of interest. Thus, while we have no intention of publicizing a submission, we can assume no obligation to keep it confidential. It is our fixed policy to consider investigator-initiated research proposals from persons outside the Company upon the following conditions: 1. That the submission is not made in confidence and is not accompanied by any reservation or condition whatever which imposes upon Pfizer any obligation or restriction with regard to its use. 2 That the submitter's rights shall be only those given under the patent laws and/or under any written contract to which the submitter and Pfizer may mutually agree. We sincerely hope the information in this statement has been helpful in clarifying our position with regard to the submission of investigator-initiated research proposals. I acknowledge that I have read the above statement 'Pfizer Policy on Submission of Ideas', which sets forth your policy on the submission of ideas by persons outside your company. I agree that in making this submission, I shall be bound by the terms and conditions set forth in the policy statement. In consideration of your examining my idea, I release your company from any liability for any use of all or any portion thereof, except such liability as may arise with respect to a valid new patent now or hereafter issued to me. Getting Assistance Visit the IIR Website Send an to IIR@pfizer.com Call IIR Hotline in US: 877-IIR-5670/ (Mon Fri 9:30am to 3:30 PM EST) Outside the US, call: /3/ of 22

22 Table of Figures Figure 1 Multi-Select Data Fields Add 5 Figure 2 Multi-Select Data Fields Remove 5 Figure 3 Click to attach file 6 Figure 4 Browse computer for document and click Upload 6 Figure 5 Select File Folder category from dropdown list 6 Figure 6 To add additional documents Select Insert Additional Item 6 Figure 7 To view, change or remove document select icon to the left of the attachment 6 Figure 8 Submission form headers 7 Figure 9 Navigation Buttons located at the bottom of each page 7 Figure 10 Required Field Indicators 8 Figure 11 Error Message 9 Figure 12 Error Message Details 9 Figure 13 Submit Final 10 Figure 14 Submission Complete Confirmations 10 Figure 15 Primary Correspondence Contact Options 17 Figure 16 Site Contact Role 17 Figure 17 Contracting Organization Type 18 Figure 18 IIR Submission Website Home Page 19 thereafter may not be recopied, reproduced or otherwise redistributed. Except as expressly back to Table provided of Contents 2/3/ of 22

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