Investigator Activities Quick Reference Guide. Sanofi/Genzyme October 2013

Transcription

1 Investigator Activities Quick Reference Guide Sanofi/Genzyme October 2013

2 Contents INVESTIGATOR ACTIVITIES QUICK REFERENCE GUIDE... 1 I. INTRODUCTION... 3 II. HOW TO REGISTER AND LOG IN... 6 III. HOW TO SUBMIT AN APPLICATION... 8 IV. HOW TO PROVIDE ADDITIONAL STUDY INFORMATION V. HOW TO SUBMIT STUDY STATUS UPDATES VII. HOW TO REQUEST A PAYMENT VIII. HOW TO REQUEST DRUG SUPPLY IX. HOW TO SUBMIT A PUBLICATION/PRESENTATION X. FRQUENTLY ASKED QUESTIONS (FAQS) HOW CAN I GET HELP? WHAT IF I CAN T LOGIN? WHAT IF I HAVE A QUESTION ABOUT MY SUBMISSION? WHAT IF I WANT TO ADD MORE INFORMATION AFTER I CLICK SUBMIT? HOW LONG DOES MY VISIONTRACKER SESSION LAST? HOW DO I PRINT MY SUBMITTED APPLICATON? VI. DATA DICTIONARY page 2

3 I. INTRODUCTION The purpose of this guide is to provide guidance to Investigator Sponsors applying online for Sanofi/Genzyme support of Investigator Sponsored Studies (ISS) or Investigator Sponsored Trials (IST). WHAT WE SUPPORT At Sanofi/Genzyme, we have always taken an outward looking approach to research, recognizing that important advancement in medical science has many sources and paths to success. In this spirit, we have established ISS/IST programs to consider potential support of research that is initiated and led by independent scientists who are not affiliated with Sanofi/Genzyme. The goal of Sanofi/Genzyme s ISS/IST programs are to promote research that has the potential to advance our understanding of the scientific, medical, or health economic information related to therapies manufactured by Sanofi/Genzyme. Research results may lead to a greater understanding and knowledge of diseases and therapies, and may spark new ideas for further research. WHO IS ELIGIBLE Researchers worldwide may apply to Sanofi/Genzyme for research support involving: Clinical studies of a marketed Sanofi/Genzyme product or device, including research of an unapproved new use (disease or indication). Observational studies, such as epidemiologic research in any of Sanofi/Genzyme s core diseases or therapeutic areas. Health outcomes research, especially related to core therapeutic areas. In vitro and animal studies of a marketed Sanofi/Genzyme product or device. HOW TO PARTICIPATE Investigators interested in Sanofi/Genzyme s ISS/IST program must submit an online application outlining their research project and request for support. The application will be evaluated by a Sanofi/Genzyme Review Committee. Submission of the application is made via an electronic internet based tool. There are several steps: 1. Submission of a research concept and proposed research budget. For certain products in the United States, the investigator is asked to first submit a summary of their research concept. 2. Review by a therapeutically aligned Review Committee of the research concept proposal. 3. If the research concept is favorably received by the Review Committee, submission of a full proposed protocol (for clinical studies) and proposed research budget. The applicant will be updated on the status of the proposal throughout the review process. Upon review and approval of the full protocol and detailed study budget by the Review Committee, Sanofi/Genzyme will send the researcher a Research Support Agreement containing terms and conditions of support to be approved by the researcher and the researcher s institution. This includes institutional review board or ethics committee approval of the protocol, where applicable, and page 3

4 Sanofi/Genzyme review of the researcher s proposed listing of study information on public website, e.g., ClinicalTrials.gov or EudraCT (eudract.ema.europa.eu). BEFORE YOU BEGIN Before initiating the online application, potential applicants can contact the appropriate Medical Affairs Department in their region for an explanation of the electronic application process in the context of a proposed research concept. Medical Affairs contact information or answers to questions may be requested through the following contacts: Sanofi: saists@sanofi aventis.com Genzyme: Europe eumedinfo@genzyme.com Japan koho@genzyme.com United States and Canada medinfo@genzyme.com Asia Pacific medinfoasia@genzyme.com Latin America medinfo.latam@genzyme.com ONLINE ISS/IST APPLICATION An application for research support from Sanofi/Genzyme may be initiated by using the researcher portal for online submissions in the Visiontracker system. Sanofi URL address: Genzyme URL address: Registering in Visiontracker Researchers must register/create an account in Visiontracker at the time of first use. This account may be used for all research applications submitted by the researcher to Sanofi/Genzyme. Detailed instructions regarding the online ISS/IST application process can be found in the Application Instructions section of the online application. RESEARCHER RESPONSIBILITIES AND REQUIREMENTS Researchers who seek Sanofi/Genzyme support are obligated under the Research Support Agreement to abide by regulatory standards of research rigor, business ethics, and patient privacy applicable to human clinical and other research. page 4

5 Status Reporting Researchers who receive Sanofi/Genzyme support must agree to keep Sanofi/Genzyme informed on the progress and status of their research, including (but not limited to): Prior to public disclosure, submission to Sanofi/Genzyme of the description of the study that is required to be posted on a public website, e.g., clinicaltrials.gov or EudraCT. Details such as patient enrollment, numbers of animals treated, etc. Any amendments to the original protocol. Proof of approval of the study (and any changes requested or required) by local or national regulatory authorities and ethics committees. Plans to publish or present interim and/or final study results. Notification of study completion. Regulatory, Ethical, and Safety Responsibilities Investigators participating in research supported by Sanofi/Genzyme must conduct their research according to International Conference on Harmonization (ICH) Good Clinical Practice (GCP) provisions, if applicable, and comply with all national and local rules, regulations, and safety reporting obligations. This includes (but is not limited to) activities such as: Securing country specific regulatory approvals, if required. Applying and obtaining ethics committee or institutional review board approval. Reporting required data to local authorities. Reporting adverse events and serious adverse events to Sanofi/Genzyme and other applicable regulatory or local authorities. Study Registration, Publication, and Reporting To support transparency endorsed by the International Committee of Medical Journal Editors (ICJME), Sanofi/Genzyme requires ISS/IST researchers who receive Sanofi/Genzyme support to post approved information about their clinical studies on a public clinical trials website, such as EudraCT (eudract.ema.europa.eu), or an equivalent country specific trial registry, in accordance with the Research Support Agreement with Sanofi/Genzyme. Researchers may also be obligated to publish findings generated by the study in a peer reviewed scientific medical journal or online publication. page 5

6 II. HOW TO REGISTER AND LOG IN To register and receive a User ID and password for the Sanofi/Genzyme study system, begin by accessing the appropriate web link to Visiontracker: Sanofi web link: Genzyme web link: REGISTER TO RECEIVE A USER ID AND PASSWORD 1. Click the Need a User ID link. 2. Complete the Registration form. Required fields are marked with an * [asterisk]. 3. Click OK when complete. LOGIN WITH USER ID AND PASSWORD An with your User ID will be sent to the address provided during registration. If the message is not received in 20 minutes, search your Junk E mail folder, in case it was classified as junk mail. A second will be sent containing a temporary password. 1. Log in using the new User ID and the temporary password. page 6

7 NOTE: Notice the Forgot Password link; in the future, if you require a new password, click this link and follow the procedure below. 2. The temporary password works only once. You must create a new password prior to logging again. Follow the on screen instructions. If a password does not meet the security requirements, the system will provide messages to guide you. 3. The following screen will appear after you have successfully created a new password. page 7

8 III. HOW TO SUBMIT AN APPLICATION 1. Log in to the Visiontracker system. 2. From the Task List tab click on New Study. 3. Review and scroll down to accept the New Study application agreement; click the Accept box at the bottom of the text and then click OK. 4. From the New Grant Dialog, select a Product and Country, using the drop down menus; then click OK. MAIN NAVIGATION TABS The main navigation tabs will display at the top of the screen. Begin with the Main tab and complete all the fields under each tab. page 8

9 Each tab contains required fields. All required files are marked with an * [asterisk]. Main Summary of Concept (Sanofi US products only) Study Info Support Attachments To switch from one tab to another, click on the intended tab or use the arrow at the bottom of the page to switch to the next tab in the series. SAVE STUDY APPLICATION 5. Enter a Study Title and then click the Save button. A Save confirmation displays. It contains a temporary application number. This is the study application s identification number prior to submission. A new number will be assigned after the completed application has been submitted SUBMIT APPLICATION 6. When complete, click the Submit button. When the submission is successful, a new number is assigned to the completed application. Please record this number for future inquires. An acknowledgement confirmation will also be sent. Red text indicates items that must be completed before the system will accept the study application. Click on each main tab and search for fields shown in red. These required fields must be completed in order for the system to accept the study application. Once corrected, click the Submit button again. page 9

10 TIPS Click Copy to automatically copy information entered during registration (such as address, address, etc.) into the Sponsor Investigator section on the Main tab and the Legal/Contracting Contact Information for Primary Site on the Support tab. Click Save every 15 minutes to prevent loss of any data entered. Be sure your study application is complete and accurate before submitting. Submitted applications cannot be edited. The Submit button identifies any missing required fields, which change to red text. Click Save to hide the red text. Caution: Do not click Submit until you are ready to submit because you will not be able to make any changes once all required fields are complete. You cannot edit the study application after it has been submitted. To locate previously completed applications by clicking the All My Studies tab. The Copy Application link is used to copy a previously submitted study application. Costs fields: The empty boxes for the Costs data entry fields are narrow (shown below). These fields expand after you enter the amount and move into another field. page 10

11 ATTACHMENTS Original Budget, CV, or Protocol Attachment(s) To attach the original budget, CV, or protocol documents during the original submission only follow the 6 steps below. If you have an attachment that is not one of these three types of attachments, or if you are attaching a document after the original submission, see the steps below titled Additional Attachments. 1. Click on the Attachments tab. 2. Click on the paperclip icon. 3. A pop up window appears; click the Browse button. 4. Navigate to the appropriate folder on your computer, click to highlight the file name, then click the Open button. 5. At the next screen, enter a description of the attachment (optional). 6. Click OK. page 11

12 Additional Attachments If you are attaching a document after the original submission or you are not attaching the original budget, CV, or protocol documents. Follow the steps below. 1. Click on the Attachments tab. 2. Click the Post New link with the paperclip icon, under the Additional Attachments section. 3. A pop up window displays; click the Browse button. 4. Navigate to the appropriate folder on your computer, click to highlight the file name, then click the Open button. page 12

13 5. At the next screen, select the type of publication from the drop down menu. In this example, an Abstract is being attached. 6. Enter a description of the attachment (optional). 7. Click OK.. IV. HOW TO PROVIDE ADDITIONAL STUDY INFORMATION You will be notified via if additional information is required for your Investigator Sponsored Trial/Investigator Sponsored Submission (ISS/IST) submission. 1. Click the link in the message and log in. 2. From the Task List tab, locate the study requiring additional information. 3. Click the Additional Info Required link. This link allows you to edit the application. 4. Add the requested information and click the Submit button when finished. This study application disappears from your Task List after submitting it. page 13

14 V. HOW TO SUBMIT STUDY STATUS UPDATES Active studies require updates periodically. You will be notified via when a Study Status Update is required. 1. Click the link in the message and log in. 2. The Task List will display, locate the study requiring additional information. 3. Click the View or Add Status Updates link. 4. Scroll to the Study Status Update section and click the Add link. The pop up window for Study Status Updates appears. page 14

15 5. Fill in current patient enrollment and study details. The first column, Current Dates, contains the information that was entered during the last study status update (in the example below, September 12, 14 patients). The Updated Dates column is the new information to be submitted during the current study status update. In this example, the patient enrollment is being increased to 15 patients as of September Click OK when your updates have been entered. 7. Click the Submit button (not shown) to send notification to the company and complete the study status update. VII. HOW TO REQUEST A PAYMENT When an agreed upon milestone has been completed and you wish to request payment, follow the process below. 1. Log in to the Visiontracker system. 2. Locate the study using either the Task List or All My Studies tab. 3. Click the View or Add Status Updates link. page 15

16 4. Click on the Study Status Updates tab. 5. Scroll to the section titled Invoicing and click the Add link. 6. Click on the paperclip icon. TIP: Scroll to the right in order to access the edit icon if needed. page 16

17 7. Navigate to the location on your computer where the invoice is stored and click to highlight the file name, then click Open. 8. At this last screen, enter a description and click OK. page 17

18 VIII. HOW TO REQUEST DRUG SUPPLY If you require additional product, follow the process below. 1. Log in to the Visiontracker system. 2. Locate the study by using either the Task List or All My Studies tab. 3. Click the View or Add Status Updates link. 4. Click on the Study Status Updates tab. 5. Scroll to the section titled Additional Product Request and click the Add link. 6. Select the product from the drop down list. TIP: Scroll to the right to locate the drop down menu button. page 18

19 7. Complete the form; required fields are marked with an * [asterisk]. 8. Click OK when finished. 9. Click the Submit button. IX. HOW TO SUBMIT A PUBLICATION/PRESENTATION Submit your publications for a study by following the process below. 1. Log in to the Visiontracker system. 2. Locate the study using either the Task List or All My Studies tab. 3. Click the View or Add Status Updates link. 4. Click on the Attachments tab. 5. Under the Additional Attachments section, click the Post New link near the paperclip icon. 6. A pop up window appears; click the Browse button. 7. Navigate to the appropriate folder on your computer, click to highlight the file name, then click the Open button. page 19

20 8. At the next screen, select the type of publication from the drop down menu. In this example, we are attaching an Abstract. 9. Enter a description of the attachment (optional). 10. Click OK.. page 20

21 X. FRQUENTLY ASKED QUESTIONS (FAQS) 1. HOW CAN I GET HELP? To receive technical support while using the Visiontracker system contact the Envision Technology Solutions (ETS) help desk. ETS provides technical support for the Sanofi/Genzyme Visiontracker application program. There are several ways to contact the Envision Technology Solutions (ETS) help desk. A) From the web screen: 1. Click the Contact Us link (left corner of the web page). 2. Select Technical Support from the Address to field. 4. Select a Subject from the drop down menu. 5. Select a Related to item from the drop down menu. 6. Type your Message into the box. 7. To attach a screen shot or other documentation, click the Browse button, navigate to the file location, click on the file name, and then click the Open button. 8. Click Send. B) the ETS help desk: visiontracker_general_requests@envisionpharmagroup.com C) Call the ETS help desk: USA Hotline: Europe Hotline: (9 AM 4 PM EST) (9 AM 4 PM GMT) 2. WHAT IF I CAN T LOGIN? Double check that you have your user ID entered correctly into the User ID field. If you have forgotten your password, click on the Forgot Password link. The system will send a temporary, one time use password. After you have received your new password and login, you will be required to create a new password. You can then log in with the new password. If you do not recall your User ID, the ETS help desk: visiontracker_general_requests@envisionpharmagroup.com page 21

22 Call the ETS help desk: USA Hotline: Europe Hotline: (9 AM 4 PM EST) (9 AM 4 PM GMT) 3. WHAT IF I HAVE A QUESTION ABOUT MY SUBMISSION? For questions regarding the submission, applicants can contact the appropriate Medical Affairs Department in their region for an explanation. Medical Affairs contact information or answers to questions may be requested through the following contacts: Sanofi: saists@sanofi aventis.com Genzyme: Europe eumedinfo@genzyme.com Japan koho@genzyme.com United States and Canada medinfo@genzyme.com Asia Pacific medinfoasia@genzyme.com Latin America MEDINFO.LATAM@GENZYME.COM 4. WHAT IF I WANT TO ADD MORE INFORMATION AFTER I CLICK SUBMIT? Unfortunately, you cannot edit it any further after you have submitted the study application. If Sanofi/Genzyme requests additional information from you, they can open up the study application to allow you to add more information. You may send Sanofi/Genzyme a message explaining why you need to make changes to the study application already submitted. 1. Click on the Contact Us link on the left side of the web page. 2. A Contact Form will appear. Required fields are marked with an * [asterisk]. 3. From the *Address to field, select the Appropriate Medical Affairs Office from the drop down menu. page 22

23 4. Select a *Subject from the drop down menu. 5. Select a *Related to item from the drop down menu. 6. Type your *Message into the box. 7. To attach a screen shot or other documentation click the Browse button. 8. Navigate to the file location, click on the file name, and then click the Open button. 9. Click Send. page 23

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25 5. HOW LONG DOES MY VISIONTRACKER SESSION LAST? Your web session will time out after 240 minutes and you will be prompted to reenter your Username and Password information. Like many other Web applications, this time limit exists for security purposes. If using Internet Explorer, you might try refreshing the browser memory. However, if you left the browser window open for more than 240 minutes with an incomplete study proposal: 1. Press F5, then click the Logout button in the left column. 2. Exit out of the browser, completely shutting it down. 3. Open Internet Explorer again and log in to the web link. 4. Press F5 and see if your data were recovered. We recommend that Investigators save their work often to avoid this issue. When stepping away for a while, investigators should log off the system rather than leave the browser window open. 6. HOW DO I PRINT MY SUBMITTED APPLICATON? Here is one way to print your submitted application. 1. Log in to the Visiontracker system. 2. Click on the All My Studies tab. 3. Click on the Tracking Number of the study you wish to print. 4. Click on the print icon, located in the top right corner. 5. A PDF file is automatically created for you to print or save. 6. To print, click the Open button. page 25

26 7. You may see a security warning; if so, click Allow to give you permission to open the file. When the file opens, click the File menu and then click Print. The study application will print to the printer that you have previously configured as your default printer. page 26

27 VI. DATA DICTIONARY [See attached Spreadsheet Help file Sanofi Genzyme Investigator PWB.xlsx]