Reference safety information how is reference safety. The investigators brochure must contain reference safety information rsi, to be used for assessing the expectedness of serious adverse reactions sars that occur during a clinical trial. What is reference safety information rsi rsi should be a list of medical events that defines which reactions are expected for the investigational medicinal product imp. If the rsi is within ib it should be a clearly identified separate section. Hello and welcome to reference safety information ii. Reference safety information rsi for a clinical trial. Annual safety report an annual summary of all serious adverse events for an active compound in clinical evaluation with a safety evaluation relating to the ongoing study ies new upcoming format. Sop 4 protocol and investigational brochure content. The investigator s brochure must contain reference safety information rsi, to be used for assessing the expectedness of serious adverse reactions sars that occur during a clinical trial. Jan 18, 2017 hello and welcome to reference safety information ii. Stay on the safe side reference safety information europe. Mar 01, 2018 the reference safety information section the fda regulations have been mirrored by updates in european guidance and regulation in 2011 and 2014, which are more detailed than in the u. There should be a specific section in the investigators brochure entitled reference safety information for assessment of expectedness of serious adverse reactionsand this section should be the basis for expectedness assessment, not the general safety information section. In drug development, the investigator s brochure ib is a comprehensive document summarizing the body of information about an investigational product ip or study drug obtained during a drug trial.
When submitting a clinical trial application the reference safety information rsi should be, when applicable, within the summary of product characteristics smpc or within the investigators brochure ib. The investigator s brochure ib will be produced following the ich guidelines. Compliance matters, good clinical practice my name is balall naeem and i have been with the mhra for more than 10 years now. Guidance for the submission and conduct of clinical trials. The rsi should be within the investigator s brochure ib or smpc.
Update investigators brochure ib at least once per year according to good clinical practice. Reference safety information rsi for a clinical trial for. Also provide information on any final and ongoing changes to the nationallocal authorized product information. Safety reporting sop hull university teaching hospitals. The reference safety information serves different purposes like information to the investigators about the safety profile of an investigational medicinal product imp, basis for expectedness assessment of an adverse reaction by the investigator sponsor for expedite reporting and annual safety reporting, as well as surveillance of participants safety in a. Reference safety information rsi defines which reactions that are expected for the investigational medicinal product imp being administered to subjects participating in a clinical trial.
The dcsi is an integral part of the investigator s brochure and documents the adverse events which, based on the information available so far, could be reasonably assumed to be associated with enter compound number and therefore considered expected for the purposes of expedited reporting to regulatory authorities and investigators. Depending on the nature of inspection this may be covered during medical information interview session or the reference safety information session. Medicines and healthcare products regulatory agency. Clinical trial facilitation group cftg question and.
Ich guideline e2f on development safety update report. The future of investigator brochures in eu clinical trials. The investigators brochure is given to clinicians, investigators, and other healthcare professionals involved in the conduct of clinical trials for instance, the clinical trial coordinators and study nurses. Reference safety information should be clearly identifiable in the initial clinical trial authorisation cta application to the mhra. Reference safety information product specific investigator brochure or spc. During clinical studies serious unexpected serious adverse reactions susars annual safetyreport asr new format. Reference safety information rsi for a clinical trial for new clinical trial applications. Efpia position paper on reference safety information 200916 final. Reference safety information the rsi is a list of expected serious adverse reactions, which are classified using preferred terms pts according to the medical dictionary for regulatory activities meddra. At the end of the reporting period the sponsor may assess the new safety information that has been generated and submit any proposed safety changes to the ib or reference safety.
In the absence of detailed guidance or a template for the content of the investigator. The information on this page is current as of april 1 2019. For suggested format of investigators brochure refer to guidance for industry. Reference safety information for clinical trials mhra. The ib is a compilation of nonclinical and clinical data relevant to the study of the medicine in humans it is the single most comprehensive document summarising.
Recent eu national competent authority nca focus on clinical trial ct reference safety information rsi has resulted in an increase in rejections of investigator brochure ib updates and ct authorisations cta. For example, the investigator s brochure is not the rsi. Reference safety information for assessment of expectedness of. They require the inclusion of a specifically labelled section called the reference safety information rsi and provide more requirements on the content. Efpia september 2016 position paper on reference safety information draft final 4. Investigators brochure for medical device investigations. Safety monitoring and reporting for clinical trials in europe. Although the ib also serves other purposes, it is primarily written to enable investigators conducting clinical studies to assess the risks and benefits associated with an investigational product. Dasatinib bms354825 investigator brochure summary of changes to the investigator brochure section change escalation study number was section 5. Management of safety information from clinical trials. The ib is a document of critical importance throughout the drug development process and is updated with new information as it becomes available.
This post is a followup that will address some of the queries that have been received since the first post was published and give. Inconsistencies and recommendations a survey was undertaken to gain an understanding of. Remember the entire investigators brochure ib is not the rsi, but a clearly defined section of it should be if. Guideline for the preparation of investigators brochures.
An overview of the periodic safety update report for. This is a deliverable of the clinical trials facilitation group ctfg, replacing the previous version dated december 20. Sop 4 protocol and investigational brochure content, design. The investigators brochure ib is intended to provide the investigator with details necessary to manage a clinical trial and study participants. Seriousness the definition of serious is defined on the basis of international consensus ich e2a5, but it still requires medical judgment. Clinical safety introduction of two phase 3 studies ca180034 and ca180035, which were designed to assess the safety and efficacy of different dosing schedules and to. Reports which add significant information on the specificity, increase in occurrence or severity of a known, documented serious. Request pdf survey of safety information in the investigator s brochure. Overview of adverse reaction reporting requirements in. This section should include information on the frequency and nature of the adverse reactions if the imp has a marketing authorisation in several member states concerned with. Investigators brochure guideline 10 july 2002 3 introduction the investigators brochure ib is a compilation of all relevant nonclinical and clinical data for a drug undergoing clinical investigation. Safety monitoring and reporting in clinical trials.
This post is a followup that will address some of the queries that have been received since the first post was published and give some further. Edition 10, dated 04 february 2014 disclosure statement this document contains information that is confidential and proprietary to millennium pharmaceuticals, inc millennium. Update investigator s brochure ib at least once per year according to good clinical practice. The investigators brochure ib will be produced following the ich guidelines. In drug development, the investigators brochure ib is a comprehensive document summarizing the body of information about an investigational product ip or study drug obtained during a drug trial. Mar 02, 2016 reference safety information for clinical trials posted by. Estimated exposure and use patterns provide accurate estimation of. Information for the investigator basis for expectedness for susar reporting basis for annual safety report there was inconsistency among sponsors inconsistency among member states multiple gnas findings in gcp inspections. Investigator s brochure for medical device investigations. The primary purpose of the safety information in the investigators brochure ib is to provide investigators and other stakeholders with the sponsors current understanding of the risk profile of the investigational product ip and corresponding risk mitigation strategies. Protocol, informed consent documents, and investigator brochure. One single definitive list or document that determines which serious adverse reactions sars require expedited reporting and which are exempt.
A survey was undertaken to gain an understanding of current industry practices in the preparation of the safety information for the investigators brochure ib. The reference safety information section the fda regulations have been mirrored by updates in european guidance and regulation in 2011 and 2014, which are more detailed than in the u. The reference safety information rsi for any investigational medicinal products imps involved in a clinical trial must stay consistent during each reporting period. For investigator initiated ind applications that have a right of reference to an existing manufacturer. Feb 21, 2018 summary of information relating to safety and effectiveness in humans obtained from prior clinical studies. Investigators may obtain investigator s brochure ib from ind products manufacturer.
Stem reference safety information update dr kirsty wydenbach. The rsi is a list of expected serious adverse reactions, which are classified using preferred terms. The rsi should be within the investigators brochure ib or smpc. The investigators brochure ib is a multidisciplinary document that summarises the main elements of an entire development programme to date. The sponsor of a clinical trial is defined as an individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a study. The cover letter for the clinical trial authorisation application should state where the rsi is located. As reported in the december 2017 issue of safety observer, the heads of medicines agencies hma have published a new version of their guidance document entitled questions and answers reference safety information rsi. Survey of safety information in the investigators brochure.
New requirements for reference safety information in the eu. Safety information that acts as a reference against which the expectedness of. Summary of data and guidance for the investigators. The investigator s brochure ib is a compilation of the clinical and nonclinical data on. The rsi should list serious adverse reactions sars which are considered expected with the investigational product. The reference safety information serves different purposes like information to the investigators about the safety profile of an investigational medicinal product imp, basis for expectedness assessment of an adverse reaction by the investigator sponsor for expedite reporting and annual safety reporting, as well as surveillance of participant. For suggested format of investigator s brochure refer to guidance for industry. Efpia position paper on reference safety information. For suggested format of investigators brochure refer to guidance. From a post marketing perspective the rsi is indeed all the relevant safety information relating to the product including the investigators brochure ib the summary of product characteristics smpc and the core data sheet cds. Hopefully you will all have read my first reference safety information rsi post which focused on how the rsi should be identifiable, approved and consistent. The expectedness of an adverse reaction shall be determined by the sponsor according to the reference document. Reference safety information guidance for clinical trials. They may print off this document for training and reference purposes.
Changes to reference safety information list any significant changes made to the reference safety information within the reporting interval. Furthermore, as noted for severity below, a particular ae term may be. Reference safety information how is reference safety information abbreviated. Types of reference safety information summary of product characteristics spc patient information leaflet company core data sheet ccds company core safety information ccsi investigator s brochures abbreviated prescribing information 4 mandatory. Provision of reference safety information to healthcare professionals and patients is a legal requirement. The reference safety information serves different purposes like information to the investigators about the safety profile of an investigational medicinal product imp, basis for expectedness assessment of an adverse reaction by the investigator sponsor for expedite. Information for the investigator basis for expectedness for susar reporting. Safety monitoring and reporting in clinical trials involving therapeutic goods 2. Investigators brochure orteronel tak 700 millennium pharmaceuticals, inc.
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