Electronic Protocol Inquiry Platform

1 Version: Effective Date: 01 NOV2020 PPD Proprietary and Confidential Page 1 of 17 Electronic Protocol Inquiry Platform (ePIP) Site User (SU) User Manual Version: Effective Date: 01 NOV2020 PPD Proprietary and Confidential Page 2 of 17 Table of Contents Submit New Inquiry ..4 Inquiries Requiring Check Inquiry Status ..11 Reporting ..13 View Details on Inquiry Page.

2 14 FAQ ..15 Training Materials ..16 Session Time Version: Effective Date: 01 NOV2020 PPD Proprietary and Confidential Page 3 of 17 Site User Manual The eP IP Platform will display the Site User dashboard after the user s login credentials pass authentic ation and authorization Site User Dashboard The digit 9 in the icon in dicates the number of outstanding inquiries pending site user response. From the Site User Dashboard page, the user can: Submit a new Inquiry Follo w up on an Inquiry requiring action View all in quiries (Reporting) Access the Check Status screen from the Protocol Inquiry menu to loc ate open inquiries Access the FAQ & Training Mat erials under Resources Provide system feedback Version: Effective Date.

3 01 NOV2020 PPD Proprietary and Confidential Page 4 of 17 Submit New Inquiry A new Inquiry can be submitted by clicking the Submit New Inquiry icon or by clic king the Submit New Inquiry sub-menu. After cli cking a sele ction, the Submit New Inquiry Step 1 Pick Protocol page will appear. There are 3parameters which must be set prior to proceeding to the Step 2 Fill Out Form page: Sele ct the sp onsor; the Sponsor List only displays sponsors assigned to the user. Select the Protocol ; the Protocol List only displays protocols assigned to the user. The Protocol li st will be refreshed according to the selected sponsor. Se lect the site; the Site List only displa ys sites assigned to user . The site list will be refreshed according to the sele cted sponsor and Protocol .

4 *Please co ntact your site monitor if a desired study or site is not avail able in the drop downs. Cli ck the Next button to validate the 3 selections (sponsor, Protocol , and site) The system will display a red message below any section indicating errors. If not errors are found the system will advance to Step 2. Submit New Submit New Inquiry Icon Inquiry Menu Submit New Inquiry Step 1 Select sponsor from the drop down menu. Select pr ot ocol from the dr op down menu. Select site from th e dr op down menu. Version: Effective Date: 01 NOV2020 PPD Proprietary and Confidential Page 5 of 17 After clic kin g the Next button in Step 1, the Submit New Inquiry , Step 2 Fill out Fo rm page will appear.

5 Some fields are auto-prefilled by the system: Sponsor, Pro toc ol # and Site # are auto-generated per user sele ction in Step 1. PI, Study Coordinator, Country, Tele phone, and Fax are prefill ed based on data in PPD s Cli nical Trial Management System. (CTMS). (Note: if any of this information is incorrect, please contact the site monitor to request an update in CTMS.) Users must sel ect a Subject Status. Sele ctions include: Screened, Randomized, and Other. If Other is sel ected then users must enter an additional descriptor such as Pre-screening or General Question. Users are required to enter a response in the Inquir y Description field. The field all ows up to 2,000 characters. (Note: If 2,000 characters are insufficie nt to document the question, then please summarize key points in the Inquiry description field and attach a Word document containing further detail.)

6 Users may sp ell check their comments by cli cking the Check spelling function. Users may upload single or multiple file(s) by clic king the Browse button. Users may upload additional fil es by clic king the +Another button. Submit New Inquiry Step 2 Prior to uploading an attachment, users must review the attachment for prohibited subject identifiers and indicate that the attachment does not contain prohibited subject identifiers. Version: Effective Date: 01 NOV2020 PPD Proprietary and Confidential Page 6 of 17 Users are required to select the Urgency of their inquir y.

7 The system defaults to Not Ur gent. Urgency options are: Not Urgent Urgent Subject waiting at site Urgent - Other Users should only sel ect Urgent Subject wait at site or Urgent - other if a patient is waiting at the site. A warning message will appear directing users to submit the Inquiry and call the hotline number found in the Investigator Site File Notebook. Urgent Subject Waiting at Site Urgent - Other Version: Effective Date: 01 NOV2020 PPD Proprietary and Confidential Page 7 of 17 After cli ckin g the Revie w button in Step 2, the Submit New Inquiry Step 3 page will appear for use rs to review and co nfir m their entries before submissi on.

8 Uploaded fil e(s) may be viewed by clic king the file name. Ensure all prohibited subject identifiers have been redacted. The user must check the checkbox regardin g subject safety and rig hts The Edit button allows users to return to Step 2 for editing Submit New Inquiry Step 3 This check box must be selected to Submit the Inquiry Click Submit to complete and submit Inquiry . Click the Edi t button to return to Step 2 for editing. By clic king the Submit button in Step 3, the submission is completed and the Submit New Inquiry Completed page will appear. A link is avail able for the user to download the newly created Inquiry Submit Another button will navigate the user to the Submit New Inquir y Step 1 page Back to Home button will navigate the user to the Site User Dashboard page Submit New Inquiry Completed Page Click the link to download a compressed file for your records.

9 Version: Effective Date: 01 NOV2020 PPD Proprietary and Confidential Page 8 of 17 Inquiries Requiring Acti on The system provides two ways for users to foll ow up on outstanding inquiri es. Users may click the Inquiries Requiring Ac tion icon or click the Inquiries Requiring Ac tion sub-menu. Inquiries Requiring Inquiries Requiring Action Icon Action Menu After clic kin g Inquiries Requiring Ac tion the Inquiries Requiring Ac tion Step 1 page will ap pear. On this page, all user specific inquir ies (with Pending SU status) will be listed.

10 Displa y defaults to Urgent-Subject Waiting at Site inquiri es on the top, followed by Urgent-Other, and then by the time aged. Each column except the Ac tions column may be sorted by cli cking the column header. The default number of inquir ies displayed per page is 25. Users may change the number to 10, 25, 50, and 75. Urgent inquiri es are highli ghted with an ! symbol in the Actions column. The OBO column helps users identify inquiri es created on behalf of (OBO) the site by PPD. Status Column Icons indicate Urgent: >20 hours Red Exclamation Burst Approaching Deadli ne: 14~20 hours Orange Runner On Time: <14 hours G reen Clock Inquiries Requiring Action Step 1 Urgent inquiries lis te d first and indicated by a red exclamation point.