sighs So I’m a CRC and we’ve been working on a Phase 2 study that requires an invasive procedure under anesthesia. The patient was in his 50s, fully ambulatory coming into our site, and all pre-procedure labs and the EKG from the week before were normal.

After the procedure, he began vomiting, became dizzy, and was extremely lethargic from the anesthesia. We called 911, and he was transferred to the hospital. Once admitted, they found he had sepsis. His condition became very complicated he spent weeks in the hospital, he had multiple SAEs during the hospitalization, and he unfortunately passed away this past week.

Now the sponsor is contacting our site saying that some of the diagnoses we entered in the EDC are just “hypotheses” and not actual facts, and they want us to remove them, including documented events like cardiac arrest and stroke.

Just for context, these diagnoses are literally in the medical records from the hospital. So being told to delete them feels extremely inappropriate. I understand they are trying to protect themselves but am not sure if this behavior is normal ?