Notes

1 Good Afternoon everyone, I’m Bhanu Gajjala I will be presenting on behalf of Boris Reznichenko. Today, Lilia Zaltsman and I will co-present slides on the submissions roadmap for publishing and technology. If you have any questions we will be happy to answer them at the end.

2 This presentation is designed to introduce you to access prerequisites, submission project tools, project publishing leads, publishing processes, turnaround and quality expectations.
The following slides contain the information to help the team to meet the submission schedule

3 So what is a prerequisite to be successful? Be proactively trained and/or gain access to the systems and tools you will need. There are five critical systems and tools: GEPIC, OST (stands for Otsuka Style Template), CMC Access, SharePoint and shared drive.
Remember - poor planning almost always results in crisis. Raise issues or questions to the appropriate personnel as they occur. Do not postpone issue resolution until it is critical as it may impact timelines

4 This slide contains a snapshot of the Access Checklist for submissions. Please complete in its entirety and provide to your PM after the KoM meeting. Checking the tools prior will ensure tight timelines are met AND reduces headaches!
7
GEPIC ACCESS
First, identify who needs to have access: Functional Team Members, Contingent Workers, and Alliance Team Members.

Secondly, specify what level of access is required - Product/Role/Author/Reviewer/CMC (quality) access

8 GEPIC Access and Quick Reference Guides can be requested through the GEPIC & GQEDMS Knowledge Community SharePoint Site. The snapshot to the right depicts a location of the user account request form.

Please note that GEPIC Training is required prior to gaining access through the assigned training in your Learning System.

Contact IT Help for issues with setup

10 The Otsuka Style Guide is essential to be used by the author. All documents must be created using OST installed. Model Documents which are stored in GEPIC contain the latest outline, instructions, and formatting for submissions. Use of model documents helps us to focus on content and not formatting, minimizing formatting or validation issues. Remember that formatting consistency and tfacilitation of hyperlinks and bookmarks aid the reviewer greatly. Despite common belief, that these are publishing requirements, they are actually the Health Authority Requirement.
 
13 The Scope of RLP team is to combine the documents into volumes. Facilitate Headers and Footers, Hyperlinks (for final publishing) and creating publishing prepared TOCs, Handoff for Functional Approval and to the SLP team

SLP Team publishes individual documents and files, provides hyperlinks other documents and submits to the Health Authority

14 The left side in the green boxes show the deliverables published by the RLP team.

Types of deliverables published by SLP are in the blue boxes on the right

 
15 This slide explains RLP Publishing Workflow

First RLP Requestor compiles the Report Publishing Planner. The RPP. And stores it in GEPIC for CSRs or in SharePoint for deliverables other than CSRs

The RPP is then QC’ed by RLP requestor and for Final publishing of CSRs the RPP needs to be sent approval

The RLP Requestor then notifies RLP Team to start publishing using OPDC clinical report publishing mailbox

Typical publishing timelines for Draft and Final publishing cycles are mentioned in the chart below

Once receiving the notification to start publishing RLP publisher conducts the publishing activities, by creating the assembly, assigning the documents and splitting volumes as per RPP. The publisher facilitates navigational aid (hyperlinking for final publishing), applies page scaling, generates publishing prepared Table of contents, Publishes and then performs post publishing as necessary

A comprehensive QC is then conducted by the QC publisher using the 9 milestones seen above.

A QC issue log is utilized to track any of the findings and provide appropriate resolution

QC Checklist is a dashboard style document is completed by QC Publisher to be used by RLP Lead

 
16 A senior RLP publisher conducts a second level RLP lead technical QC

Will check all QC documentation and send for approval after each publish Cycle

RLP Lead then uploads the published output to GEPIC and sends a notification to the requestor that its ready for their review

The RLP Requestor then reviews the uploaded published output, responds whether a republish is required

If no republish is required GEPIC approval is completed by the content owner and a notification to SLP lead is sent to update the TOC tracker