Veeda’s successful execution of a bioequivalence study involving ovarian cancer patients
May 20, 2021
Individual Case Study Report (ICSR) is a source of data in pharmacovigilance that contains information on the adverse events caused by medications. It is reported by an individual or individual’s physician. Reports from member countries of the WHO Network are the primary target of ICSRs. The Uppsala Monitoring Centre (UMC), on behalf of the WHO, manages and produces a worldwide individual case safety report database called the VigiBase. Medical coding aims to translate information on adverse effects into terminology that can be defined and analyzed quickly as the terminology used for similar event may vary from region to region. As a part of medical coding, a generic terminology from a medical coding dictionary, such as MedDRA (the most widely used medical coding dictionary) is used for an adverse event. UMC has updated MedDRA 23.0 to capture the ICSRs for COVID-19 treatment and the current MedDRA version in use is 23.1.
It should be noted that there are insufficient safety details about the multiple therapeutic options for COVID-19 infection. It is important to exchange information on suspected adverse effects from all of the drugs that are used to treat COVID-19, as well as how the virus and the medications used to treat it affect patients with co-morbidities that are already on various medicines for managing conditions like hypertension, diabetes, etc. Given the global scale of the pandemic, all attempts should be made to reduce delays in reporting events related to COVID-19, so that countries can benefit as early as possible from each other’s experience. Data points other than demographic details (sex and age of a patient) that are particularly useful for analyzing and identifying COVID-19 related cases include:
• Medical history of the patient inclusive of the concurrent medications
• The therapeutic reaction of the drug
• Laboratory tests results
• If there is death, then the reason behind death
• Patient narrative, diagnostic reports, and comments from the healthcare provider
EMA has recently released the complete guidance on processing and submission of ICSRs in the context of the global pandemic COVID-19.The detailed guidance document refers to the updated MedDRA version 23.0 for getting the terms related to COVID-19 and also notifies the release of a COVID-19 SMQ with MedDRA version 23.1. It calls upon organisations to comply with their legal obligations to disclose reported adverse drug reactions in compliance with the provisions of Articles 107 and 107a of Directive 2001/83/EC. It also requests the organizations to comply with the guidelines laid down in GVP Module VI, ICH E2B Guidelines and the current version of MedDRA term selection.
The important points from the document regarding capturing ICSRs for COVID treatment include:
• Complete information that includes the medical and administrative data for a valid ICSR should be submitted in a standardized manner in the relevant ICH-E2B data elements and in the narrative section for serious adverse event cases.
• No report should be documented for the misuse of non-medicinal products that may contain substances which are also found in the medicinal product.
• The guidance stated to discuss the reports of drugs having off-label use with no associated suspected adverse reactions in the Periodic Safety Update Report or in the product Risk Management Plan. These reports should not be submitted to EudraVigilance as ICSR.
• If a pharmaceutical product is used to prevent or cure COVID-19 infection after getting approval and no possible adverse effect is recorded for lack of therapeutic effectiveness, then it should be sent to EudraVigilance as an ICSR within 15 days. The reason being that COVID-19 is a potentially life-threatening illness.
• If any medication has a valid Adverse Drug Reaction (ADR) and demonstrates a lack of clinical efficacy for the treatment of COVID-19, an ICSR should be requested regardless of whether or not the application of the drug as off-label.
• ICSRs should be considered as spontaneous reports. If ICSRs are of named patient programs having an active collection of adverse events, then they will be considered as solicited reports.
• Given the substantial rise in the number of publications related to COVID19, the marketing authorization holders should abstain themselves from creating duplicates ICSRs in the EudraVigilance. Those AE reports should be submitted by the Medical Literature Monitoring Service.
• For every single identifiable patient, one case should be generated when respecting the exclusion requirements given in GVP module VI.C.220.127.116.11.
• Specific COVID-19 terms have been included in MedDRA version 23.1. Stakeholders should ensure that when coding ICSRs in compliance with the MedDRA, they choose the correct specific COVID-19 related word.
• If the COVID-19 condition is found to aggravate, then usually the ‘Reaction (MedDRA)’ field should be populated with either the MedDRA LLT “COVID-19 aggravated” (LLT Code 10084657) or MedDRA LLT “COVID-19 pneumonia aggravated” (LLT Code 10084658) term.
• If a suspected adverse reaction befalls in the off label use environment, the guidance provided in GVP Module VI chapter VI.C.18.104.22.168 should be followed for coding AE in the ICSR.
• The medicinal drugs that are used in the treatment of confirmed or suspected COVID-19 infection should be populated with the most precise COVID-19 related MedDRA LLT (Low level term).
• If any approved medication is used as a prophylaxis against COVID-19 infection, the indication “COVID-19 prophylaxis” (LLT code 10084458) should be filled as MedDRA LLT.
• If the medicine is used as immunization against COVID-19 infection, it should be filled in MedDRA under the PT as “COVID-19 immunization”.
• If the medication is used as a cure for COVID-19 infection, the indication under the PT ‘COVID-19 treatment’ should be filled with the most appropriate MedDRA LLT, unless a more accurate code word is available.
• If a patient has reported COVID-19 infection, then the patient medical history data should be filled with the most reliable MedDRA LLT COVID-19 terms.
• The most accurate MedDRA LLT codes such as “Exposure to SARS-CoV-2” or “Occupational exposure to SARS-CoV-2” should be entered for ICSRs where the alleged medicinal agent was not used to treat COVID-19 infection and where it is specifically stated that the patient has documented exposure to COVID-19 without contracting an infection.
• The code for the name of the test should be populated under the most accurate MedDRA LLT, as applicable. Code like PT’s ‘Coronavirus test’, ‘SARS-CoV-2 test’ or ‘SARS-CoV-2 antibody test’ can be used.
The updated MedDra Version 23.1 contains 50 new COVID-19 related LLTs/PTs. Similarly, a revised guideline on post-marketing adverse case reporting for prescription drugs and nutritional supplements during the COVID-19 has been released by the FDA. Formance should be maintained as far as possible, but to ensure business stability, the FDA agrees that consistency in adverse event reporting responsibilities would be required. The post-marketing notice on Mandatory Reporting Requirement of COVID-19 from Health Canada also aligns with the views of the FDA.The MHRA has also included a new section on PV in its guidance on regulatory flexibility during COVID-19.
• COVID-19 impact on Pharmacovigilance. Accessed at
COVID-19 impact on Pharmacovigilance
• Detailed guidance on ICSRs in the context of COVID-19. Accessed at
• ICSR in Pharmacovigilance. Accessed at https://www.idmp1.com/wiki/icsr/
• How to capture ICSRs for COVID-19 treatments. Accessed at https://www.who-umc.org/global-pharmacovigilance/covid-19/how-to-report-icsrs-for-covid-19-treatments/
• EMA DETAILED GUIDELINES ON VALIDITY AND CODING OF ICSR IN CONTEXT OF COVID 19. Accessed at https://allaboutpharmacovigilance.org/ema-detailed-guidelines-on-validity-and-coding-of-icsr-in-context-of-covid-19/
• What’s New MedDRA Version 23.1. Accessed at