Post production changes in clinical data management can be difficult to navigate, and a lack of talented pharmaceutical industry resources has driven up demand for Clinical Data Managers . In the last 4 years alone, massive growth has come for clinical data managers resulting in a more than 93 percent growth rate according to Recruiter.com. Those who understand what do with difficult tasks, like dealing with post-production changes (PPCs) or mid-study updates (MSUs) after a clinical database has gone live, or into the production environment, are scarce. Post-production changes (PPC) in clinical data management often include changes to forms, structures, fields and/or edit checks, and they can be attributed to planned or unplanned updates, meaning: Planned post-production changes (PPCs) refer to study specific updates that were known by a clinical data manager in advance or specified in the clinical study protocol or an amendment; and Unplanned post-production changes (PPCs) refer to updates not included in the clinical study protocol and are needed for reasons that may include Sponsor requests or misinterpretation of, or new knowledge about, the clinical study protocol. In either case, a post-production change (PPC) can result in a disruption of the clinical study and present many challenges to the timelines and budget. In speaking from experience, and further with other Clinical Data Managers at MMS, there multiple ways to navigate these challenges. Clinical data managers need to maintain the integrity of clinical data Any updates to the already existing database could undermine the integrity of the clinical data. For this reason, it is vital that clinical data managers follow an exact process, ensuring that all steps are documented thoroughly. It is equally important to consider the electronic data capture (EDC) software being utilized for the study, as there are limitations with many individual systems. Approval by other teams is also key. Have any post-production changes (PPC) approved by Programmers and Statisticians to ensure data integrity in exports and gain confirmation that primary or secondary outcomes are not negatively impacted. Post-production changes (PPC) can come with numerous obstacles. Yet, with proper planning and understanding of the necessary steps to take, clinical data managers can seamlessly integrate the updates into the ongoing database and train new data management professionals to fill pharmaceutical industry needs along the way. Justification, impact assessment, and validation A solid justification for the post-production change (PPC) must be provided. Clinical data managers should ask, “why is the update necessary?” Once this question is answered, the next important consideration is the impact of the post-production change (PPC). What impact will this update have on clinical data that is already present in the database?

1. Understanding Post Production changes (PPC)
in Clinical Data Management (CDM)
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soumyapottola@gmail.com |
https://clinicalda.blogspot.com/2024/04/understanding-
post-production-changes.html

2. As a data manager, one of the most common pain points are PPC's. They
are necessary evil & you can't avoid them, but if you clearly understand
them - then you can manage them successfully.
PPC's can be planned (you know it's coming & you can prepare) and
unplanned (Surprise!!! These are real shockers)

3. PPC's usually will have below steps:
1. Identifying the changes
2. Impact Analysis
3. Define timelines for PPC
4. PPC approvals
5. Implementing the changes
6. Document learnings in "Lesson Learnt Document"

4. 1. Identifying the changes
This is not always a straight forward activity & needs inputs from
several study team members. Ensure you identify each change correctly
& document the same in change control form / change control
document.

5. 2. Impact Analysis
This is the most important step of PPC. As Data Manager we are not
always aware of complete impact of the changes requested by sponsor. (
for Example - custom functions updates, RTSM updates) so involving all
the required study team members ( programmers, coders, clinical team
member, stats etc)

6. Along with technical impact DM also need to assess the impact on
budget & resource. How much the requested changes cost? Does study
has the budget for the same? Are people available to work on the PPC?
etc

7. 3. Define timelines for PPC
Once impact analysis is done, ensure to come up with timelines
for each activity (ex: programming, UAT, approval, push to prod
etc). Share the timelines with entire study team and get an
agreement about the same.

8. 4. PPC approvals
Ensure PPC request form is thoroughly reviewed and approved by
sponsor / study team members including programmer, project
manager etc.
Do not start the work unless you have all the approvals in place.

9. 5. Implementing the changes
As DM ensure the changes are programmed correctly, tested in
UAT and are ready to be pushed to production. Also do think about
unseen issues like data loss, access related issues wont arise due
to implementation.
Get required signoff on UAT documentations, go live checklists. Do
keep CRA's and site managers updates about the implementation.

11. 6. Document learnings in "Lesson Learnt Document"
Once the PPC is implemented, document lessons learn specially
for unplanned PPC's about what lead to PPC? What is the root
cause? Why was it missed first time?