1. Janet J. Li, Aakar Shah Pfizer Inc.
Something Old, Something New: A little programming management can go a long way
Janet J. Li, Aakar Shah
Pfizer Inc.

2. Have you ever been in Benjamin’s, Emma’s, or Olivia’s shoes?
Benjamin has been frantically searching for the most up-to-date version of his study’s SDTM and ADaM datasets. The previous study lead has already left the organization, so he can’t ask him for the whereabouts.
Emma is a statistical programming manager who wished she had easier access to the status of the projects that her direct report lead
Olivia is the director of statistical programming in her organization and she wishes for a high-level summary of the studies that fall under her umbrella

3. Project management and tracking tool
Allow us to manage ourselves, others, deliverables, and timelines at study level
A summary of study highlights can be pulled from individual study tracker files and be presented as an aggregate report to upper management

4. Study Tracker Tool
Study team contact information
Study files management
Study highlights and deliverables
Ongoing
Completed
Future
Risk management

5. Study team contact information

6. Study files management
In the highlighted example, “Study_01_SDRG” is hyperlinked to the Study 01 SDTM Reviewer’s Guide file pathname and we can see that the most current version of the SDTM Reviewer’s Guide is a draft from December 1, 2017.

7. Study Highlights and Deliverables

8. Risk Management
The above table details a qualitative risk register for Study 04
Risk: identified risks are described
Impact: consequence of the risk (“critical”, “high”, “medium”, “low”)
Probability: likelihood of the occurrence of risk (“high”, “medium”, “low”)
Risk Mitigating Actions: responses to the occurrence of the risk

9. Management Summary
High-level summary of study highlights from the individual study tracker files
Can be presented as aggregate report to upper management
Built according to needs of organization/team

10. Aggregate Study Highlights and Timelines

11. Aggregate Study Highlights and Timelines
We used the HIGHLOW plot statement (SG procedures, GTL) to create the aggregate study highlights and timelines
Use the HIGHLOW parameter y instead of x to create the horizontal bar segments seen in the aggregate highlights & timelines report

12. Aggregate Risk Summary Report
Overview of the risks for all studies (can be built to only show the risks that have high or critical impact as seen in the table)

13. Conclusion
Successful implementation of this proposed project management tool
The tool should be reviewed and updated on a regular basis as new information becomes available
Can be updated to fit the needs of any statistical programming organization or team

14. Contact Information
Name: Janet J. Li Company: Pfizer Inc. City/State: San Francisco, CA Name: Aakar Shah Company: Pfizer Inc. City/State: San Francisco, CA