challence # 8 an SAE during the weekend. the declaration did not take place within 24 hours. What to do?
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Word from the author:
Following a comment from a user, I would like to clarify some details of this video:
What the regulatory texts say: ICH R1 (1996) and R2 (2016): All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator’s Brochure) identifies as not needing immediate reporting.
Art. R. 1123-54. French health code (Year 2006) or (Year 2016) – The investigator notifies the promoter without delay from the day on which he becomes aware of all serious adverse events, except those listed in the protocol or in the brochure for the investigator as not requiring immediate notification. This notification is the subject of a written report and is followed by detailed written additional reports.
Text found in most clinical study protocols: (Sponsor) must be notified of the occurrence of any SAE as soon, within 24hours of the Investigator, designee, or site personnel’s knowledge of the event.
Most international clinical study protocols speak of the 24h rule. It’s on this basis that we produced this video. It is clear that the investigators must follow the study protocol authorize by the authorities as well as the law in force.
Transcription texte :
Hello everyone ! It’s Vanessa Montanari from the clinical research blog for Pharmaspecific today we will see a new case. Tthis is a case of serious adverse events you have a serious adverse event arriving at 6 p.m. on a Friday evening and the site coordinator report it only on Monday. What should you check first ? First thing I want to tell you that a serious adverse event should be reported in 24 hours after taking knowledge of the investigator therefore from when a study investigator learned about this serious adverse event within 24 hours. This serious adverse event must be reported to pharmacovigilance department. Pharmacovigilance is a very important in clinical research. So I said pharmacovigilance but it can be also materiovigilance for studies with medical devices therefore pharmacovigilance or materiovigilance should be taken very seriously. You must respect these 24 hours of statement you need to check when the principal investigator or a co-investigator has taken note of this serious adverse event did he was aware on Friday evening at 6 p.m. or then during weekend Saturday or Sunday or so did he was aware on Monday. So this is important because from this moment he became aware you have to count the 24 hours so it often happens that one of the study investigators is present during the weekend and who take care about the patient so that means that he was aware about this serious adverse event during the weekend. At that time, he must maintain the 24 hours of reporting this serious adverse event requires ask the center to document the awareness of the serious adverse event by the principal investigator or the sub-investigator and this must be entered in the medical file. If the report has not been made within 24 hours after awareness by the principal investigator or sub-investigator, we will have to train the center again on the reporting of serious adverse events be aware that in an emergency if the investigator does not have the form. There can still make a statement with a simple email to the service of pharmacovigilance by giving certain information as the patient’s initials if it is accepted by the study the patient number country, at least description of SAE and then a gradation of this SAE you need to give some details on these SAEs in particular. Is this SAE is related or not to Study products this is an important information for the vigilance service you must document any training of the investigator in the training form that you will file in the investigator binder and then you should report in your monitoring report, and in your follow-up letter all these information.Your project manager must be immediately informed of this type of deviation which is a deviation which can go from minor to major when it’s something that happens again.
I hope this video helped you. I would also like to tell you that pharmaspecific create a white paper to explain how to conduct your studies clinical success. This guide is a guide about a hundred pages feedback from our team to help you better understand clinical trials. you can download this guide at the bottom of the video, I suggest you visit the research blog site which here and also the site of Pharmaspecific. Pharmaspecific is a CRO in clinical research. You can discover on our site all our services. I thank you all.
See you soon ! Goodbye !