Project Manager (CTM) Training – What’s New ePIP Phase II

Planned Outage Notification 2 ● Internal PPD Notification ● Bulletin on ePIP log in page for External Users − Target = 9pm EST 01-Feb-13 through 6pm EST 3-Feb-13

Required Training 3 ● New or revised training materials will be automatically presented as they are available − User must view and acknowledge before proceeding ● Phase 2 training videos for Sponsor and Site users will be available immediately. PM and MM videos forthcoming. Click the link to open the video Check to acknowledge completion

Dashboard – Project Manager role 4 ● The option Follow-up on Outstanding Inquiries has been renamed to Inquiries Requiring Action ● The option Check Status of Previous Submissions has been removed and replaced with View All Inquiries (Reporting) − The Check Status option is available in the header toolbar

Submit Protocol Inquiry – PPD Team 5 ● PPD users may submit an inquiry on behalf of the PPD Team − For internal processing and tracking of protocol questions; only visible to the PPD Team and Sponsor

Submit Protocol Inquiry – Completed Inquiry 6 ● A Completed Inquiry is submitted for tracking purposes only − Inquiry has been resolved by the team outside of ePIP − PIF is closed upon submission; there is no workflow and no s − Attachments are required: Telephone Contact report, , paper PIF.

Submit Protocol Inquiry – Completed Inquiry (continued) 7 Fields from the Follow-Up feature are entered upon creation of a Completed PIF, as there is no Follow-Up.

Notifications – Project Manager role 8 ● PM users will receive hourly batch notifications for all New or Pending PM inquiries − Sponsor and Protocol for each PIF will be listed − s for Urgent PIFs will be sent immediately and included in batch s *****It’s good business practice to log in daily***** * Do not rely solely on notifications*

Inquiries Requiring Action 9 ● Sorts by highest priority: Urgent-Subject Waiting, Urgent- Other, Not Urgent; then by days Aged within each grouping Status icon shows how long the PIF has been assigned to MM Site # includes Sponsor Site # and CTMS Site # Status icon shows how long the PIF has been assigned to PM

Inquiries Requiring Action – Inquiry Type 10 ● Inquiry Type options have changed − Deviations has been removed − Protocol Deviations and ICH/GCP Deviations have been added ● If either are selected, an additional classification is required − Targeted Eligibility has been added ● Use only on studies where MM review of Targeted Eligibility is contracted ● MM users can edit the Inquiry Type entered by the PM ● The PM cannot change the MM-entered Inquiry Type ● The reason for change is available through the Audit Trail via Reporting Protocol Deviation and ICH/GCP Deviations have an additional classification to align with CTMS-R conventions

Inquiries Requiring Action – Respond Directly 11 ● Request Decision option Approved is not available if Past Deviation Acknowledged is checked

Inquiries Requiring Action – Respond Directly OBO 12 ● Is Additional Information Required may be checked for OBO inquiries if the PIF was submitted by a PM user − The PIF will route to the PM to reply OBO − notification will be sent to the PM; no s will be sent to the site Additional information may not be requested for OBO inquiries submitted by MM, RA2, or RA1 users

Inquiries Requiring Action – Forward to Medical Monitor 13 ● Enter Primary, Secondary, and Global Backup MMs to determine Notification recipients and prioritization − Primary=Immediate Secondary=5 hoursBackup=14 hours − The medical monitors will receive batch notifications every 3 hours for inquiries Pending MM >24hours − The same medical monitor user may be selected for each of the three fields The Primary MMs for each region will be listed first, followed by the Secondary, and Global Backup. Use the labels indicating Level and Region assignments to assist with selecting the appropriate recipient

Inquiries Requiring Action – Forward to Sponsor 14 ● Enter Primary, Secondary, and Backup sponsor recipients to determine Notification recipients and prioritization − Primary=Immediate Secondary=14 hoursBackup=20 hours − The same sponsor user may be selected for each of the three fields At least 1 sponsor user must be assigned to the protocol to forward to Sponsor

Reporting – Filter and Export 15 ● Users can filter by ePIF# ● PPD users may filter inquiries by the Medical Monitor who acted on an inquiry ● Users can export the Inquiry Listing Report (Excel) for all selected/filtered inquiries (Refer to Reporting training for more details)

Creating Users – Upload Template 16 ● Excel format replaces CSV format and additional fields provided for ease of use but are not imported CTMS Sponso r ID Sponsor Name CTMS Protocol Number CTMS Site Number Sponsor Site Number FirstMiddleLast Internal/ ExternalRole Protocol Number Enter CTMS Sponsor Unique ID Enter CTMS Sponsor Name (not imported ) Enter CTMS Protocol Number ID Enter CTMS unique Site ID Number for site users. Enter “All” for RAs, PM, MM and sponsor users Enter the Sponsor Site Number for site users or All' for sponsor and internal users (not imported) Enter the user’s address. Each user must have their own unique .(Ensure the address is complete and accurate. Ensure addresses do not contain apostrophes.) Enter the Users First Name Enter the users Middle Name (Not required) Enter the user’s Last Name (Remove apostroph es) Enter Internal for all RAs, PM. and MMs user roles. Enter “External” for sponsor and site user roles mm pm ra2 su sponsor (all in lower cases). Protocol Number (not imported) 1-TEST Pharmac eutical Corp1-PROTID 1- GreenExternalsu ABC-123- Test All User Roles must be in lower case.

17 ● Research Administrators (RA1) − Route New inquiries for follow-up to the MM (in absence of PM) − Reset the status of any PIF to Pending PM to reroute the inquiry − Cancel any inquiry − Edit user-entered initial PIF submission data (e.g. subject status, subject id) − Replace attachments in an ePIF to redact confidential data − Archive a protocol − Schedule automated Inquiry Listing Report generation per protocol − Adjust Sponsor notification timepoints per sponsor and per protocol − Label Medical Monitors with Level and Region assignments per protocol − Generate User Account Report per protocol (includes training details) ● To request completion of any of these RA1 activities, submit an ePIP Quick Ticket through the IT Service Desk − Written approval from the PM (CTM) is required Enhancements for Other Roles

18 ● Medical Monitors − Add annotation comments and attachments ● Research Assistants (RA2) − Replace attachments in an ePIF to redact confidential data Enhancements for Other Roles (continued)