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Understanding Post Production changes (PPC) in Clinical Data Management (CDM)

 Understanding Post Production changes (PPC) in Clinical Data Management (CDM)

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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)
PPC's usually will have below steps:
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.
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)
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
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.
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.
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.
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?


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