Project Manager (CTM) Training – What’s New

ePIP Phase II

Planned Outage Notification

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● Internal PPD Email Notification● Bulletin on ePIP log in page for External Users

− Target = 9pm EST 01-Feb-13 through 6pm EST 3-Feb-13

Required Training

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● 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

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● 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

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● 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

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● 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 emails− Attachments are required: Telephone Contact report, email, paper PIF.

Submit Protocol Inquiry – Completed Inquiry (continued)

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Fields from the Follow-Up feature are entered upon creation of a Completed

PIF, as there is no Follow-Up.

Email Notifications – Project Manager role

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● PM users will receive hourly batch email notifications for all New or Pending PM inquiries− Sponsor and Protocol for each PIF will be listed− Emails for Urgent PIFs will be sent immediately and included in batch emails

*****It’s good business practice to log in daily****** Do not rely solely on email notifications*

Inquiries Requiring Action

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● 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

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● 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

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● Request Decision option Approved is not available if Past Deviation Acknowledged is checked

Inquiries Requiring Action – Respond Directly OBO

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● 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− Email notification will be sent to the PM; no emails 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

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● Enter Primary, Secondary, and Global Backup MMs to determine Email Notification recipients and prioritization− Primary=Immediate Secondary=5 hours Backup=14 hours− The medical monitors will receive batch email 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

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● Enter Primary, Secondary, and Backup sponsor recipients to determine Email Notification recipients and prioritization− Primary=Immediate Secondary=14 hours Backup=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

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● 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

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● Excel format replaces CSV format and additional fields provided for ease of use but are not imported

CTMS Sponsor ID

Sponsor Name

CTMS Protocol Number

CTMS Site Number

Sponsor Site Number EMAIL First Middle Last

Internal/External Role

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 email address. Each user must have their own unique email.(Ensure the email address is complete and accurate. Ensure email addresses do not contain apostrophes.)

Enter the Users First Name

Enter the users Middle Name(Not required)

Enter the user’s Last Name (Remove apostrophes)

Enter Internal for all RAs, PM. and MMs user roles. Enter“External” for sponsor and site user roles

mmpmra2susponsor(all in lower cases).

Protocol Number (not imported)

1-TEST

Pharmaceutical Corp 1-PROTID 1-11555AB 1001 ppdisu@test.com David   Green External su

ABC-123-Test

All User Roles must be in lower case.

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● 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 email 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

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● Medical Monitors− Add annotation comments and attachments

● Research Assistants (RA2)− Replace attachments in an ePIF to redact confidential data

Enhancements for Other Roles (continued)