Challenge # 2 My investigator refuses to put certain adverse events in the CRF

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Text transcription :

Hello everyone.
It’s Vanessa Montanari from the clinical research blog for Pharmaspecific.

Today, i will tell you about a new subject. My investigator refuses to put certain adverse events in the case report form, what to do?

It happens that the investigator does not want to add certain adverse events that
you found in the medical record, in the the CRF then what should you do in this case ?

First of all, you have to ask him why he’s going to explain to you why he don’t
want to add this adverse event and it will allow you to be able to assess whether these reasons are correct.

Second thing, once you have evaluated this you can then see with him let him put if he really finds that this adverse event is not significant. He will have to specify it in the medical file therefore in the medical file and will add a non-clinically significant mention and then he will put his initials and it will date. So if someone asks the question he finds this not clinically meaningful and it was noted by the doctor. When
I say someone, in general, it is a listener. Then you will have to train your investigator of the protocol and collection of adverse events. You need explain re explain him how we do collect adverse event as it which type of AE we collects since depending on the protocol. Sometimes, the protocol can ask this that certain adverse events, are not collected, it can happen so it is necessary retrain him to the protocol and to this part then if the investigator refuses to follow the protocol at that time. You will have to notify your project manager quickly to see what actions you are going to have to carry out with project manager and the sponsor to be able to resolve this problem. Also remember to list adverse events in your monitoring report if for exemple, the investigator said that he don’t want to add Something. Exemple : Neutropenia grade 1 in the crf, at this time you must note this information in your report you put that the investigator considers this adverse event as not clinically significant. You will specify that in your report and you will also specify it in your follow-up letter that you are going to send to the investigator to be able to document this whole situation here.

I hope it helped you. You can go to the clinical research blog website to have
more clinical research advice. You can also visit the website Pharmaspecific therefore our CRO in clinical research to see what type of activities we do.

Thank you and see you soon !
See you later !