Life Sciences

Oops! I Just Deleted Production Data For An EDC Study

Imagine accidently deleting lots of production clinical data. What do you do? How do you recover?

Those are the tough questions our client was recently faced with when one of their Oracle Clinical (OC) power users ran the Delete Study Information function in the system with the intention of deleting patient data for only a handful of patients on a given Data Collection Instrument (DCI) and Clinical Planned Event. Little did he know, the parameter limits for that particular Delete Study Information job were not correctly bang_headspecified and, in one fell swoop, all the production data for the DCI – including over 500 received DCIs and 200,000 responses – was gone!  Literally, gone. To make things more complicated, as all of this was happening, production data continued to be entered into the same OC/RDC database by other users in the database.

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With this particular study scheduled for close-out in two weeks, it was essential for our client to resolve the issue quickly and cost-effectively to avoid severe repercussions.

We determined that restoring the entire production database from a backup was not a viable option, as it wouldn’t include any data that was captured after the patient data was accidentally deleted. And, manually re-entering data from the backup would be difficult and time-consuming.

After evaluating a variety of possible scenarios, the team decided to bring up a clone of the client’s production database from the exact point before the data was deleted for the DCI. Using Accel-Copy, a tool that was developed by our team of life sciences-focused application developers, we were able to extract the patient data, including discrepancies, from the cloned database. From there, we were able to restore the missing production data.

Although the client was able to get back to normal fairly quickly and continue operations with minimal disruption, it’s crucial to reiterate the importance of backing up your clinical data and pharmacovigilance systems and having a disaster recovery plan in place. Without a backup of your data, no tool (even ours!), could make things better.

To learn about our Accel-Copy, click here. If your organization needs guidance on backing up your systems or developing a disaster recovery plan, contact us by filling out this form. For general information about our life sciences offerings, click here.

About the Author

As a senior solutions architect in Perficient’s dedicated life sciences practice, Michelle Engler oversees custom clinical and safety software development activities. Her in-depth knowledge of clinical and pharmacovigilance systems allows her to fully understand customer needs and address them through the development of cost-effective applications. Michelle led the development of Simple Forms EDC, Accel-Account Manager and Accel-Copy, three industry tools that complement and enhance Oracle Clinical, Remote Data Capture (RDC) and Thesaurus Management System (TMS). She also heads the team that implements CoSign, a digital signature solution developed by ARX. Michelle has been with Perficient, via the acquisition of BioPharm Systems, since 1999.

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