DSUR LITERATURE REVIEW

So we have established what the RSI is and its purpose in clinical trials, but how do we manage it? Examples of findings often seen in this scenario include:. RSI queries can be directed to ctdhelpline mhra. It does not exempt you from the need to submit amendments to make RSI changes. Find out more about cookies. They usually stem from a lack of understanding, overly complicated processes and poor oversight. Cumulative subject exposure in clinical trials Phase I-IV Patient exposure from marketed setting Presentation of Safety Data from Clinical Trials General considerations Interval line listings of Serious Adverse Reactions SARs Cumulative summary tabulations Deaths in the reporting period Subjects who dropped out in association with any adverse event in the reporting period Significant Findings from Clinical Trials During the Reporting Period Completed trials and any interim analyses Ongoing clinical trials Other therapeutic use of investigational drug New safety data related to combination therapies Relevant Findings from Non-Interventional Studies Relevant Findings from Other Studies Safety findings from marketing experience Other Information:

Well, here are my ABCs, or in this case IACs, that if implemented correctly will help you meet the legislative requirements, and avoid Grounds for Non Acceptance and inspection findings. Expectedness can have a lot of different meanings in the medical world, but from a regulatory perspective, in relation to safety reports and Suspected Unexpected Serious Adverse Reactions SUSARs , it means whether or not the reaction is an expected side effect of the IMP, thus determining whether it does or does not need reporting in an expedited fashion. If you want to change to version 2. You could also submit an amendment at the time stating that you will not implement the new RSI until the end of the current DSUR period. Consistent You need to ensure that throughout your trial, everyone is using the same version of the RSI at the same time, especially if investigators are conducting the expectedness assessment only the causality assessment needs to be done by a medic. As you may have gathered from the blog title, a common theme that often leads to inspection findings at all of these organisations is their understanding and application of the Reference Safety Information RSI. It should be clearly identifiable in your initial CTA application.

Development Safety Update Report (DSUR)

Examples of findings often seen in this scenario include:. RSI queries can be directed to ctdhelpline mhra. In that time, I have worked across 3 different Divisions in a number of roles. Evaluation of the risks Benefit-risk considerations Conclusions Summary of important risks Consolidated safety reporting systems dsr PrimeVigilance, together with extensive in-house medical expertise provide the means for accurate ddur through DSUR production.

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Any change in RSI is a change in risk benefit! United Kingdom Head Office.

Czech Republic PrimeVigilance s. It does not mean:. You can risk assess the new version of the IB against the current version and if the RSI changes are minimal or not relevant to your study or patient population, then you can choose to continue with the current RSI in the current IB version for the remainder of the period.

dsur literature review

Well, here are my ABCs, or in this case IACs, that if implemented correctly will help you meet the legislative requirements, and avoid Grounds for Non Acceptance and inspection findings.

This means if it is the SmPC, you must control the version they use so that it is the one approved by the MHRA, not just direct them to log onto a website containing multiple versions and select one. It should be clearly identifiable in your initial CTA application.

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Development Safety Update Report (DSUR)

You could also submit an amendment at the time stating that you will not implement the new RSI until the end of the current DSUR period. Oreskoviceva 20A Zagreb. Where is it located and how do the people conducting expectedness assessments find it? If you are using a defined section in IB version 1 you cannot go to IB version 2 with new expected events listed i.

The same also applies for the SmPC, it should be clear you are referring to section 4. If you want literahure change to version 2. So a few things to note; if you submit SmPC version 2. UK blogs use cookies to make the site simpler.

For trials with marketed products, the date is the first marketing authorisation granted in the EU. So we have established what the RSI litdrature and its purpose in clinical trials, but how do we manage it? Expectedness can have a lot of different meanings in the medical world, but literxture a regulatory perspective, in relation to safety reports and Suspected Unexpected Serious Adverse Reactions SUSARsit means whether or not the reaction is an dwur side effect of the IMP, thus determining whether it does or does not need reporting in an expedited fashion.

Identifiable Where is it located and how do the people conducting expectedness assessments find it? Algorithms or expected event terms in safety databases being changed before the RSI is approved.

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It does not exempt you from the need to submit amendments to make RSI changes. You need to ensure that throughout your trial, everyone is using the same version of the RSI at the same time, especially if investigators are conducting the expectedness assessment only the causality assessment needs to be done by a medic.

This assessment will only be carried out once you submit your rsur. Sitemap Privacy policy Cookie policy Legal information.

dsur literature review

Examples of findings often seen in this scenario include: It may well do but when a MHRA medical assessor reviews this as part of your initial CTA application, they interpret it as meaning the SmPC or IB that is current at the time of the application, literaturs a changing real time current version. As you may have gathered from the blog title, a common theme that often leads to inspection findings at all of these organisations is their understanding and application of the Reference Safety Information RSI.

However, you do not have to implement the new IB.

Reference Safety Information for Clinical Trials – MHRA Inspectorate

Some of these factors revuew be considered when assessing the causality of the event to determine revifw it is a reaction; for reactions to be excluded from expedited regulatory reporting they must be listed in the RSI or clearly defined in the current approved version of the protocol.

Consistent You need to ensure that throughout your trial, everyone is using the same version of the RSI at the same time, especially if investigators are conducting the expectedness assessment only the causality assessment needs ilterature be done by a medic. Cumulative subject exposure in clinical trials Phase I-IV Patient exposure from marketed setting Presentation of Safety Data from Clinical Trials General considerations Interval line listings of Serious Adverse Reactions SARs Cumulative summary tabulations Deaths in the reporting period Subjects who dropped out in association with any adverse event in the reporting period Significant Findings from Clinical Trials During the Reporting Period Completed trials and any interim analyses Ongoing clinical trials Other therapeutic use of investigational drug New safety data related to combination literrature Relevant Findings from Non-Interventional Studies Relevant Findings from Other Studies Safety findings from marketing experience Other Information: