{"id":6327,"date":"2020-01-03T22:43:35","date_gmt":"2020-01-03T21:43:35","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=6327"},"modified":"2025-05-21T11:58:01","modified_gmt":"2025-05-21T09:58:01","slug":"adverse-events-crf","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/adverse-events-crf\/","title":{"rendered":"Challenge # 2 My investigator refuses to put certain adverse events in the CRF"},"content":{"rendered":"<p>Challenge # 2 My investigator refuses to put certain adverse events in the CRF<\/p>\n<p>This year will be a year of meeting, sharing, knowledge and development. Are you ready with us It will start with our 2020 challenge, one video per day for 30 days on monitoring.<br \/>\nFor 30 days, we will give you high added value content for quality monitoring!<\/p>\n<p><!--more--><\/p>\n<p>Join us on Instagram by clicking here: <a href=\"https:\/\/www.instagram.com\/blogrechercheclinique\/\">https:\/\/www.instagram.com\/blogrechercheclinique\/<\/a><br \/>\nDo you need clinical research? contact PHARMASPECIFIC by going to our site by clicking here: <a href=\"https:\/\/pharmaspecific.com\/devis\/\">https:\/\/pharmaspecific.com\/devis\/<\/a><\/p>\n<p>If you have any questions about the profession of clinical research associate or a career in clinical research, you can put it in the comments below. We will get back to you as soon as possible.<\/p>\n<p>Activate the subtitles!<\/p>\n<p><iframe data-src=\"https:\/\/www.youtube.com\/embed\/llqgoSl4G1k\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" class=\"lazyload\" data-load-mode=\"1\"><\/iframe><\/p>\n<p>Text transcription :<\/p>\n<p>Hello everyone.<br \/>\nIt&rsquo;s Vanessa Montanari from the clinical research blog for Pharmaspecific.<\/p>\n<p>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?<\/p>\n<p>It happens that the investigator does not want to add certain adverse events that<br \/>\nyou found in the medical record, in the the CRF then what should you do in this case ?<\/p>\n<p>First of all, you have to ask him why he&rsquo;s going to explain to you why he don&rsquo;t<br \/>\nwant to add this adverse event and it will allow you to be able to assess whether these reasons are correct.<\/p>\n<p>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<br \/>\nI 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&rsquo;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.<\/p>\n<p>I hope it helped you. You can go to the clinical research blog website to have<br \/>\nmore clinical research advice. You can also visit the website Pharmaspecific therefore our CRO in clinical research to see what type of activities we do.<\/p>\n<p>Thank you and see you soon !<br \/>\nSee you later !<\/p>","protected":false},"excerpt":{"rendered":"<p>It happens that the investigator does not want to add certain adverse events that<br \/>\nyou found in the medical record, in the the CRF then what should you do in this case ?<\/p>","protected":false},"author":4,"featured_media":14163,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":{"facebook_122143508198123560_331463380343150":""},"rop_publish_now_history":[],"rop_publish_now_status":"pending","_sitemap_exclude":false,"_sitemap_priority":"","_sitemap_frequency":"","_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[449],"tags":[66,41,155,8],"class_list":{"0":"post-6327","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-pratiquer-le-metier-dattache-de-recherche-clinique","8":"tag-attache-de-recherche-clinique","9":"tag-cro","10":"tag-etude-clinique","11":"tag-recherche-clinique"},"translation":{"provider":"WPGlobus","version":"3.0.2","language":"en","enabled_languages":["fr","en"],"languages":{"fr":{"title":true,"content":true,"excerpt":true},"en":{"title":false,"content":false,"excerpt":false}}},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.9 - 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However, not all the details are in the medical records.","rel":"","context":"In &quot;Pratiquer le m\u00e9tier d'Attach\u00e9 de recherche clinique&quot;","block_context":{"text":"Pratiquer le m\u00e9tier d'Attach\u00e9 de recherche clinique","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/pratiquer-le-metier-dattache-de-recherche-clinique\/"},"img":{"alt_text":"Vid\u00e9o sur les traitement concomitants","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/traitements-concomitants.png?fit=520%2C292&ssl=1&resize=350%2C200","width":350,"height":200},"classes":[]},{"id":6439,"url":"https:\/\/blogdelarechercheclinique.com\/en\/monitoring-visit-investigator-binder\/","url_meta":{"origin":6327,"position":3},"title":"Challenge # 14 Monitoring visit: The investigator site file, What to check?","author":"Vanessa Montanari","date":"20 January 2020","format":false,"excerpt":"We're going to talk about managing the investigator binder. 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What should you ask the investigator to put in the investigator's CV?","rel":"","context":"In &quot;Clinical Research Job Interviews&quot;","block_context":{"text":"Clinical Research Job Interviews","link":"https:\/\/blogdelarechercheclinique.com\/en\/category\/clinical-research-job-interviews\/"},"img":{"alt_text":"CV investigateur","src":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/CV-investigateur.png?fit=1072%2C602&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/CV-investigateur.png?fit=1072%2C602&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/CV-investigateur.png?fit=1072%2C602&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/CV-investigateur.png?fit=1072%2C602&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/06\/CV-investigateur.png?fit=1072%2C602&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":6456,"url":"https:\/\/blogdelarechercheclinique.com\/en\/france-ask-diplomas-investigators\/","url_meta":{"origin":6327,"position":5},"title":"Challenge #18: In France, should you ask for the diplomas of the investigators?","author":"Vanessa Montanari","date":"20 January 2020","format":false,"excerpt":"Today we're going to look at a new topic. 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