Unresolved Discrepancies & Data Discussion.

Instructions:

Question 1

Unresolved discrepancies related to SAE data could lead to the study not correctly having the correct data in the end. If the specific SAE was caused by the drug/product being studied but the discrepancy was not updated properly to indicate if it truly meets the criteria, then this could affect the outcome of adverse events caused by the drug/product. If data is not being updated or recorded in real time, it can lead to a lot of reconciliations towards the end of the study (Cobert, 2018). This could lead to delays in database locks, and possibly having to create and send an expedited report to the proper people, such as the FDA, sponsor, etc (Cobert, 2018).

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Reconciliation of SAEs is needed for those in the appropriate roles to discuss the discrepancies in the item and decide if it is appropriate for the SAE and then determine the correct course of action (The SAE Reconciliation Process, n.d.). If the data does not match in the databases, when it comes time for an audit, this could be picked up on and then reported to the site/sponsor. It could also lead to question on why it wasn’t caught and why it wasn’t resolved prior to now, what data is missing or needs to be clarified, etc. (Cobert, 2018). This can also lead to inaccurate data being put into the system if a long amount of time has passed since it was originally recorded. This should try to be avoided as you want to be as accurate as possible when recording AEs/SAEs and reconciling discrepancies in real time will help avoid the chance of being inaccurate.

Question 2

Data management having a strong relationship with those conducting monitoring visits is important as these positions need to ultimately work closely with each other. When monitoring visits occur, the monitor will verify the data in the EDC against the sites source documents. If there are queries that have been issued by the data management team, the monitor will be able to help address any questions they may have to clear up any queries or discrepancies. Being able to discuss these with each other is important for the study and will help clear up any questions or problems found.

Being able to build a strong relationship starts at the beginning. When you are able to first reach out to the data management team or the monitoring team, I believe it’s important to first introduce yourself and get to know the person. If you know the persons characteristics and can effectively communicate with them it will make having to discuss queries or problems with data vs source later. I believe that open communication and expressing the goal in your work is important to creating a strong relationship. Without this, things could be misunderstood, and details could be overlooked, missed out on.

Should you be in a situation where the relationship between you and the data management or monitoring team wasn’t strong. You could develop strategies together to have a plan in place for those times when they are needed. If someone is not able to answer common questions when needed, maybe implementing a standard “cheat sheet” to look back on for the answers. Strong relationships again, start with communication, if the relationship is causing work not to be completed then maybe it could be looked into a different team member to work with. Being able to talk more to either person regarding what they are looking for specifically could help turn a relationship around that didn’t have any or much communication to begin with. Being willing to also learn common terms each person will use in their respective jobs can help turn the relationship around as each person will see that they are making an effort to help their job flow a little better.

References:

Cobert, B. (2018, April 19). Reconciliations – Clinical Trial & Drug Safety Database – C3iHC. C3i Solutions. Retrieved January 27, 2022, from https://www.c3isolutions.com/blog/reconciliations/

The SAE Reconciliation Process. (n.d.). Www.Datareconciliation.Com. Retrieved January 27, 2022, from https://www.datareconciliation.com/Data-Reconcilia…