Dd dsur


DSU vs. Neural:X use case

The DSU and DTSN:X up mixers are improved over previous versions as they attempt to treat the sounds in the tracks as objects in a three dimensional space using just a 5.1 setup. The effects can be heard when switching from DD or DTS to DSU or DTSN:X but the listener will decide if it is actually an improvement to the sound.

Height virtualization is now available as well from Dolby and DTS. Some receivers have their own rear channel speaker virtualizer function. When either DSU or DTSV:X is applied, they process the signal and take whatever effects would have been up mixed into height channels and sends them to the existing speakers and attempts to make the sound appear as if it is coming from above.

Seeing what is going on by bringing up the GUI doesn’t show much when using Dolby. So, if using virtualization on a 5.1 speaker setup, using DSU or Atmos height virtualization will simply show DSU 5.1 or Atmos 5.1 as the output signal to the speakers. It’s not very descriptive of what is going on.

DTS gives a bit more information while it up mixes. So, if playing a DTSHDMA track, one can apply Virtual:X and display the process. The DTSHDMA track will be displayed, then Neural:X since it is up mixing and then Virtual:X as it takes the processed signal to the existing speakers in the setup to make them appear to come from above. DTS:X tracks skip the neural process and go straight to Virtual:X like Atmos tracks go straight to 5.1.

While Dolby removed cross up mixing limitations, many will not be able to apply DTS up mixing to dolby tracks. Converting signals to PCM from devices will result in the ability to use both up mixers but will also kill metadata from both Atmos and DTS:X and the processing of the signal will not be the same as if using the virtualization processes with the non converted tracks.

There hasn’t been near enough information put out there by Dolby, DTS or manufacturers in a way that helps people wrap their heads around what is going on.o_OOh, and if you decide to play with PCM tracks back and forth, you will find DTS up mixing more aggressive and especially so when using Virtual:X


Sours: https://forums.audioholics.com/forums/threads/dsu-vs-neural-x-use-case.121287/

Denon AVR-X3700H AVR Review

ririt said:

Hi Circumstances, how is the sound quality compared with our previous set-up (Avm20 + MCA 50)?

Click to expand...

I don't have it dialed in yet.

Not needing all the analog cables and optical cables is a major plus.

I think the DolbyTrueHD over hdmi to the 3700 is as good or better than the blu ray player decoding it and sending it out over 5.1 analog to the AVM20.

Everything else sounds better. My TiVo cable broadcasts via hdmi, my Netflix and Amazon Prime from my FireTV over hdmi.

Getting DD+ for the first time. Definite audible improvement in all cable and streaming.

My television and my projector image (1080p) are both a bit better on 720p and 1080i sources, allowing the 3700 to upscale to 1080p instead of the displays (as I previously was doing). (Not that that had anything to do with the AVM20, I'm just saying).

I'm looking forward to learning more and tweaking further. I'm horrible at this!


Sours: https://www.audiosciencereview.com/forum/index.php?threads/denon-avr-x3700h-avr-review.15031/page-21
  1. Readers digest archive online
  2. Hay fork 3 point hitch
  3. Cha cha singers
  4. Minecraft pe castle map download

Selecting the surround decoder used in the program


Uses the decoder automatically selected by input source. The DTS Neural:X decoder is selected for DTS sources and the Dolby Surround decoder is selected for other sources.


Dolby Surround decoder. Expands the sound using a method optimized for the layout of the installed speakers. It produces the extended surround sound optimized for your speaker system. A real acoustic space (including overhead) will be created especially when object-based audio (such as Dolby Atmos content) is played.


DTS Neural:X decoder. Expands the sound using a method optimized for the layout of the installed speakers. It produces the extended surround sound optimized for your speaker system. A real acoustic space (including overhead) will be created especially when object-based audio (such as DTS:X content) is played.

Neo:6 Cinema

Uses the DTS Neo:6 decoder (or DTS-ES Matrix decoder) suitable for movies. Sounds will be output from the surround/surround back speakers.

Neo:6 Music

Uses the DTS Neo:6 decoder (or DTS-ES Matrix decoder) suitable for music. Sounds will be output from the surround/surround back speakers.

Sours: https://manual.yamaha.com/av/18/rxv685/en-US/3841550731.html
Pharmacovigilance (PV) training: AE, ADR, case processing, ICSR, PSUR, DSUR PEDAR causality labeling

Up-mixed: Dolby Surround v DTS:Neural:X

I was mid-review on the outstanding Denon AVR-X6200W 9-Channel AV Receiver when I came upon the topic of AVR sound processing, or up-mixing, and realized it might make a better standalone piece where we could talk about the sound processing outside the confides of a single product review.

Before we dive in, I want to make it very clear: Dolby and DTS fandom can run a little hot 'round the collar, but I'm not setting out to crown a winner here. Rather, my intention is to give you a baseline of expectations when comparing the two technologies and how they perform in adding height sounds to traditional surround experiences, be they stereo, 5.1 or 7.1 sources.

Also, my apologies for not including AURO 3D, which has also become available as a $150 firmware upgrade on some Denon AVRs, but my living room layout makes properly configuring AURO a bit of a headache, so I'm gonna have to sit that format out until further notice.

Denon AVR-X6200W with Dolby Atmos & DTS:X

For the purposes of our discussion today, let's get really simplistic and say there are two types of sound experiences for the home cinema environment:


experiences are simply when your AV Receiver DECODES a particular mix, be it stereo or 5.1 or Dolby Atmos. Outside of compression issues and speaker variances, you're hearing exactly what the filmmakers want you to hear.

Take me for example. I'm currently rocking a 7.2.4 KEF R Series speaker configuration capable of reproducing DIRECT sound mixes like Dolby Atmos and DTS:X. With these tracks, the Denon AVR-X6200W simply places certain sounds in certain speakers per the decoding algorithms built into Atmos and X.

When you, an avid home cinema enthusiast, end up with more speakers than a particular sound mix offers, in terms of channels or objects, you've entered the realm of UP-MIXING.

Up-mixing isn't new, of course. Dolby Pro Logic and DTS:Neo were likely part of many home surround experiences long before the prevalence of multi-channel surround sound. In addition to Dolby and DTS technologies, many AV Receivers also come with their own proprietary up-mixing modes. All of these up-mixing processors transformed 2.0-5.1 mixes into 5.1-9.1 experiences.

Denon AVR-X6200W: DTS-HD + Neural:X


Dolby Surround and DTS:Neural:X are the latest generation up-mixing processors to land in 2015+ AVRs, offering not only surround performance upgrades for stereo and 5.1 mixes, but also height channel atmospherics for stereo, 5.1 and 7.1 mixes.

UPDATE 1/30/17: The original version of this article was written at a time when DTS:X and DTS:Neural:X were semi-rare features on AVRs. Further, there was a complication with the way Denon/Marantz implemented Dolby Surround and DTS:Neural:X. Last fall, Denon updated the firmware for early 2016 model AVRs, and they can now apply Dolby Surround to DTS codecs as well as DTS:Neural:X to Dolby codecs. Also, as manufacturers revise and replace model lines, most AVR brands now offer a complete range of Dolby, DTS, and brand-based proprietary decoding and up-mixing capabilities. In other words, what was "semi-confusing" six or seven months ago is now exceptionally simple.


Since surround sound up-mixing has been around for a decade or so, we're going to focus mainly on height speaker performance to investigate how Dolby Surround and DTS:Neural:X create full hemispherical surround immersion.

KEF Ci200RR THX in-ceiling speakers

To do this, I took three Blu-rays with terrific multi-channel soundtracks and set them to output via multi-channel PCM, then watched MLB baseball on ESPN with my DVR outputting two-channel PCM, all while toggling back and forth between  to get a sense of how these two up-mixers each sounded in full 7.2.4 KEF glory...

Then I unplugged all my ear-level speakers.

Using ONLY my four KEF Ci200RR-THX in-ceiling speakers, I listened to what Dolby Surround and DTS:Neural:X isolated as "height sound" and tossed upwards.

The results were fascinating.



If you want to play along at home, my first demo is 'Seven', Chapter 35. As the film's insanely tense climax builds, Dolby and DTS both pushed skyward the droning musical score, helicopter rotors, and the echo of a gunshot. Outside those elements, dialog and most sound effects remain ear level (effectively invisible to me).

On this track, Dolby and DTS did very similar things, sonically, but measurements demonstrated DTS:Neural:X to be approximately 2-4dB more aggressive with height speaker volume levels, a measurement that was pretty consistent across the remainder of this experiment. An interesting choice, for sure. I know when I calibrate my speaker configuration, I personally to bump up height speakers about 2dB for a greater sense of immersion. In that sense, I definitely see how some listeners will flock to Dolby's more balanced approach, while others might enjoy DTS' more aggressive one.

Important to note: in casual listening, when all the ear-level speakers are running too, it's MUCH harder to hear the volume difference between Dolby Surround and DTS:Neural:X, but it might be important to you, so I thought it worth mentioning.

Road to Perdition

Next I moved to 'Road to Perdition', Chapter 4. Right about the 24 minute mark, Tom Hanks' son, standing outside a warehouse in the pouring rain, peeks in at the gangsters who are questioning a man in a chair. The rain is obviously the star of this sequence and both up-mixers crush it. But that changes when the characters start talking. Voices reverberate upwards in both up-mixers, but when you listen closely at the word "liar", the up-mixer react in strikingly different ways.

Dolby Surround produces cleaner reverb and the entire word -- liar -- is crisply audible, creating a much more lifelike warehouse echo. DTS:Neural:X, on the other hand, stumbles on individual voices, the world "liar" warbling between front and rear height speakers, revealing an obvious sense of digital processing.

This "warbling" was confirmed during MLB Baseball. Both DTS:Neural:X and Dolby Surround placed extra stadium crowd noise in the height speakers (and in the surround when those are plugged in). It's a fantastic effect; all sports should be watched this way. However, in the DTS version, announcer voices kept flitting in and out of the front height channels, almost like a radio signal coming in and out of range. I suspect the cause here is a less-than-elegant stereo PCM downmix my DVR was outputting at the time, but it still reveals a little more about how these two up-mixers do what they do. Unfortunately, I was unable to examine the baseball's native 5.1 mix because DTS:Neural:X is not an option on the X6200W when Dolby Digital is detected.


For my last demo, I went with 'Top Gun', Chapter 1. In your height speakers, you will hear elements of Kenny Loggins' Danger Zone as well as various roaring jet effects.

Once again the results surprised.

DTS:Neural:X was not only louder, but also more accurate in its height channel panning. There's a fantastic moment where a fighter jet takes off towards camera. With your entire sound system engaged, there's a tremendous whoosh as it screams past the right side of your listening environment and out to the rears. DTS:Neural:X mimics this screaming whoosh from front-right-height to rear-right-height speakers in a very dramatic fashion. Dolby Surround, by contrast, offered no such panning for this one effect, but instead ramped up front and rear rightside height channels equally, and in a much less dramatic fashion. This is something I did not notice with the entire system engaged.

Denon AVR-X6200W and VIZIO P-Series with Dolby Surround


At this point it was time to put my system back together for a review. It's fair to say, for more thorough and conclusive results, we'd probably want to check a hundred hours of content, but after these four demos and dozens of hours enjoying each up-mixer with a full 7.2.4 system engaged, I have a pretty good handle of how they each peform (from an audience perspective). More important than finding a "winner" is that we enthusiasts get to have an utterly smile-inducing surround sound experience whenever we want. In that sense Dolby Surround and DTS:Neural:X perform remarkably well (they also each have MUSIC modes).

What can we take away from this and similar experiements?

For the most part you could leave your AVR in one format or the other and never notice; that's what I did back in the Pro Logic IIx days. Likewise, if your first generation DTS:X-capable Denon or Marantz AVR is temporarily locking each up-mixer to its own branded codecs, you'll enjoy the results, but you might notice variances in the way your system sounds depending on content. However, assuming you have a choice between the two, Dolby Surround excels at spacial recreation and voice placement. It's more refined and delicate. If you feel as though you need more oomph overhead, DTS:Neural:X is a little louder and I also enjoyed the way it panned aggressive sound effects.

Thanks again to Denon for loaning us the fantastic AVR-X6200W. A full review will be up shortly.


Does your AV Receiver offer both Dolby Surround and DTS:Neural:X? Do you have a preference? Why? Is this preference for all content, or some? Jump into the FORUMS (link below) to let us know. Cheers.

See what people are saying about this story in our forums area, or check out other recent discussions.

Discs mentioned in this article: (Click for specs and reviews)
Road to Perdition (Blu-ray)
Top Gun - 3D (Blu-ray)
Se7en (Blu-ray)
Sours: https://www.highdefdigest.com/news/show/Dolby/DTS/Surround_Sound/height-speakers/Dolby_Atmos/dtsx/Denon/KEF/Yamaha/Pioneer/Onkyo/Sony/avr/av-receiver/Surround_Sound/upmixed-dolby-surround-v-dtsneuralx/32382

Dsur dd

Template for the Development Safety Update Report (DSUR) with Guidance Notes for Completion. This document is the template to be used for your DSUR with brief notes on the completion of each section. The full guidance document (if required) is available as an associated document to Standard Operating Procedure UoA-NHSG-SOP-013; alternatively the full guidance can be located via: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/developmentsafety-update-report.html All sections should be completed; when no information is available, this should be stated. All instructions are in italic and should be deleted when the report is finalised. If there have been no Serious Adverse Reactions or other safety issues within the reporting year, there is still a requirement to send the annual DSUR to the Medicines and Healthcare Products Regulatory Agency (MHRA), NHS G R&D department and the Sponsor or Co-sponsor. The executive summary should be sent to the ethics committee which provided the favourable opinion for the trial. This page should not be included as part of the submission. TMP-QA-15 V1 (22-8-15) DSUR Report Page 0 of 9 ICH E2F DSUR – Non-Commercial Sponsor Insert Study Title Insert Study Acronym DSUR number Reports should be numbered sequentially Investigational drug(s) Reporting period dd/mm/yyyy – dd/mm/yyyy Date of the Report dd/mm/yyyy Sponsor(s) name(s) and address(es) Applicable eudraCT numbers eudraCT numbers of all trials reported Chief Investigator responsible for DSUR submission: Name: Signature: The cautionary statement below should be amended as appropriate Note: This Development Safety Update Report contains confidential information. This report includes unblinded adverse event data. TMP-QA-015 V1 (22-8-15) DSUR Report Page 1 of 9 Executive Summary This section should provide a concise summary of the important information contained in the report. Together with the title page, it can serve as a ‘stand-alone’ document suitable for the submission to ethics committees and other stakeholders. The following information should be included in the Executive Summary: Introduction – report number and reporting period; Investigational drug(s) – mode(s) of action, therapeutic class (es), indication(s), dose(s), route(s) of administration, formulation(s); Estimated cumulative exposure of clinical trial subjects; Marketing approval(s)? (yes/no) – If yes, number of countries; Summary of overall safety assessment (based on section 18 of the DSUR); Summary of important risks (based on Section 19 of the DUSR); Actions taken for safety reasons including significant changes to the IB; Conclusions. Table of Contents 1. Introduction This section should include: Date of Clinical Trial Authorisation approval, Development International Birth Date of drug or International Birth Date of Drug as appropriate; Reporting period and sequential number of the report; Investigational drug(s) – mode(s) of action, therapeutic class (es), indication(s), dose(s), route(s) of administration, formulation(s); A brief description of the indication(s) and population(s) being studied. A short summary of the scope of the clinical trials covered by the report (e.g. all trials with the investigational drug, indication-specific trials, trials with combination products); A brief description and explanation of any information that has not been included in the DSUR (e.g. when written agreements with a partner company do not provide for exchange of all safety data); The rationale for submission of multiple DSURs for the investigational drug, if applicable. 2. Worldwide Marketing Authorisation Status TMP-QA-015 V1 (22-8-15) DSUR Report Page 2 of 9 This section should provide a brief narrative overview including: date of first approval, indication(s), approved dose(s), and where approved, if applicable. 3. Actions Taken in the Reporting Period for Safety Reasons This section should include a description of significant actions related to safety that have been taken during the reporting period by the sponsor, regulators, data monitoring committee or ethics committee that had an impact on the conduct of a specific clinical trial(s) or on the overall clinical development programme. The reason(s) for each action should be provided if known. Relevant updates to previous actions should also be summarised in this section (e.g. resumption of a clinical trial after suspension). This section should also summarise requests from regulatory authority(ies) that place a specific limitation on current or future development (e.g. a request to conduct long term animal studies before initiating a long term clinical trial, specification of a maximum dose to be evaluated, a request for specific safety data before initiating trials in paediatric subjects.) A cumulative listing of such requests from regulatory authorities should be provided, including any updates if applicable. This can be provided as a table, in an appendix, or in this section. 4. Changes to Reference Safety Information This section should list any significant safety-related changes to the Information Brochure (IB) or other reference safety information within the reporting period. Such changes might include information relating to exclusion criteria, contraindications, warnings, precautions, serious adverse drug reactions, adverse events of special interest, interactions, any important findings from non-clinical studies (e.g. carcinogenicity studies). Specific information relevant to these changes should be provided in the appropriate sections of the DSUR. 5. Inventory of Clinical Trials Ongoing and Completed during the Reporting Period This section should provide a brief overview of the clinical trials ongoing and completed by the sponsor during the reporting period, with detailed information presented in a table as an appendix (see examples in Appendix A, Tables 1 and 2). 6. Estimated Cumulative Exposure 6.1. Cumulative Subject Exposure in the Development Programme 6.2. Patient Exposure from Marketing Experience Sections 6.1 and 6.2 of the DSUR should provide information on cumulative exposure in clinical trials and the marketed setting, respectively. An estimation of cumulative subject exposure can help provide context for the cumulative summary tabulations of serious adverse events, and the overall assessment of safety. The accuracy of the estimation of clinical trial exposure might be limited because of a number of factors, including the rapidity of subject enrolment and the number of ongoing trials where treatment assignment remains blinded. TMP-QA-015 V1 (22-8-15) DSUR Report Page 3 of 9 For marketed drugs that are under clinical investigation, it might not be feasible or useful to obtain precise cumulative clinical trial exposure data, e.g. when the drug has been marketed for a number of years and/or has many indications. In these circumstances an explanation should be provided. 7. Data in Line Listings and Summary Tabulations Sections 7.1 – 7.3 of the DSUR should present important clinical safety information through: Interval line listings of the Serious Adverse Reactions that were reported during the period covered by the DSUR; and If appropriate, cumulative summary tabulations of serious adverse events that have been reported since the Developmental International Birth Date of the drug. The line listings and tabulations should include blinded and Unblinded clinical trial data. Unblinded data might originate from completed trials and individual cases that have been Unblinded for safety reasons (e.g. expedited reporting), if applicable. Data should not be unblinded for the specific purpose of preparing the DSUR. 7.1. Reference Information This section should specify the version of the medical coding dictionary used. If applicable, it should also specify the document and version used as Reference Safety Information for determining expectedness (e.g. IB, Summary of Product Characteristics). 7.2. Line Listings of Serious Adverse Reactions during the Reporting Period This section should summarise how case reports were selected for inclusion in the line listings. This section should not serve to provide analyses or conclusions based on the SARs. The line listings should be provided in an appendix (see Appendix A, Table 3). Where possible the line listings should include each subject only once regardless of how many SAR items are reported for the case. If there is more than one reaction, they should all be mentioned by the case should be listed under the most serious or primary adverse reaction. It is possible that the same subject could experience different SARs on different occasions (e.g. weeks apart). Under such circumstances, the SARs can be listed separately and a single subject can be included in the line listing more than once. 7.3. Cumulative Summary Tabulations of Serious Adverse Events See appendix A, Table 3 for an example of the headings for the line listing. 8. Significant Findings from Clinical Trials during the Reporting Period The information in this section can be provided by indication, when appropriate, and should address the following topics, when applicable: 8.1. Completed Clinical Trials Should provide a brief summary of clinically important emerging efficacy and safety findings from clinical trials completed during the reporting period. TMP-QA-015 V1 (22-8-15) DSUR Report Page 4 of 9 8.2. Ongoing Clinical Trials Should provide details of clinically important safety information that has arisen from ongoing clinical trials (e.g. learned through interim safety analyses or as a result of unblinding of subjects with adverse events), this section should briefly summarise the issue(s). 8.3. Long-term Follow-up Where applicable, this section should provide information from long-term follow up of subjects from clinical trials of investigational drugs. 8.4. Other Therapeutic Use of Investigational Drug This section should include clinically important information from other programmes conducted by the same sponsor or co-sponsor that follows a specific protocol. 8.5. New Safety Data Related to Combination Therapies If this DSUR is for an investigational drug that is also under development as a component of a fixed combination product or a multi-drug regimen, this section should summarise important safety findings from the combination therapy DSUR. Conversely, if this DSUR is for a multi-therapy drug or fixed combination product, this section should summarise important safety information arising from trials on the individual components. 9. Safety Findings from Non-interventional Studies This section should summarise relevant safety information from sponsored or co-sponsored non-interventional studies that becomes available during the reporting period (e.g. observational studies, epidemiological studies, active surveillance programmes. 10. Other Clinical Trial/Study Safety Information This section should summarise relevant safety information from any other sponsored or cosponsored clinical trial/study sources that becomes available during the reporting period (e.g. results from pooled analyses or meta analyses of randomised clinical trials). 11. Safety Findings from Marketing Experience If the investigational drug has been approved for marketing in any country, this section should include a concise summary of key safety findings that have arisen from marketing experience and that became available to the sponsor during the reporting period. 12. Non-clinical Data This section should summarise major safety findings from non-clinical in vivo and in vitro studies (e.g. carcinogenicity, reproduction or immunotoxicity studies) ongoing or completed during the reporting period. Implications of these findings should be discussed in the Overall Safety Assessment (section 18). TMP-QA-015 V1 (22-8-15) DSUR Report Page 5 of 9 13. Literature This section should summarise new and significant findings, either published in the scientific literature or available as unpublished manuscripts, relevant to the investigational drug during the reporting period. This section should include information from non-clinical and clinical studies and, if relevant an applicable, information on drugs of the same class. It should also summarise significant new safety information presented at a scientific meeting and published as an abstract; a copy of the abstract should be provided, if possible. 14. Other DSURs One single DSUR should be prepared for all trials being undertaken on one investigational drug. However, if multiple DSURs are to be prepared for a single investigational drug (e.g. covering different indications, development programmes, or formulations), this section should summarise significant findings from other DSURs if not presented elsewhere in the report. 15. Lack of Efficacy Data indicating lack of efficacy, or lack of efficacy relative to established therapy(ies), for investigational drugs intended to treat serious or life-threatening illnesses (e.g. excess cardiovascular adverse events in a trial of a new anti-platelet drug for acute coronary syndromes) could reflect a significant risk to the clinical trial subjects and should be summarised in this section. 16. Region-Specific Information The information in this section can be used to comply with national or regional requirements and can be provided in appendices to the DSUR. Should a DSUR be required for a country other than Britain the Chief Investigator should determine the requirements for that country. Examples of what may be included are: Cumulative summary tabulation of serious adverse reactions; List of subjects who died during the reporting period List of subjects who dropped out of clinical trials in association with an adverse event during the reporting period, whether or not thought to be drug related. Any safety issues should be addressed in Section 18 of the DSUR as appropriate; Significant manufacturing changes. 17. Late-Breaking Information This section should summarise information on potentially important safety findings that arise after the data lock point but while the DSUR is in preparation. Examples include clinically significant new case reports, important follow-up data, clinically relevant toxicological findings and any action that the sponsor or co-sponsors, data monitoring committee, or a regulatory authority has taken for safety reasons. Section 18 should also take account of this new data as appropriate. TMP-QA-015 V1 (22-8-15) DSUR Report Page 6 of 9 18. Overall Safety Assessment This section should be a concise, integrated evaluation of all new relevant clinical non-clinical and epidemiological information obtained during the reporting period relative to the previous knowledge of the investigational drug. This assessment should consider cumulative experiences, new information collected in the period covered by the DSUR and, for investigational drugs with a marketing approval, clinically significant post-marketing data. It should not summarise or repeat information presented in previous sections of the DSUR, but should provide an interpretation of the information and its implications for the clinical trial population and the development programme. If appropriate, separate assessments can be provided by therapeutic area, route of administration, formulation and/or indication. 19. Summary of Important Risks This section should provide a concise, cumulative, issue-by-issue list of important identified and potential risks, e.g. those that might lead to warning, precautions, or contraindications on labelling. Such risks might include, for example, toxicities known to be associated with a particular molecular structure or drug class, or concerns based on accumulating non-clinical or clinical data. Each risk should be re-evaluated annually and re-summarised as appropriate, based on the current state of the knowledge. New information should be highlighted. The appropriate level of detail is likely to be dependent on the stage of the drug development. For example, summaries covering drugs in early development might include information on individual cases, whereas in later development, as more knowledge and perspective are gained the information on each risk might be less detailed. Risks that have been fully addressed or resolved should remain in the summary and be briefly described, e.g. findings from toxicology studies or early clinical trials that were not borne out by later clinical data. Conclusions This section should briefly describe any changes to the previous knowledge or efficacy and safety resulting from information gained since the last DSUR. The conclusions should outline the actions that have been or will be taken to address emerging safety issues. 20. Appendices to the DSUR The DSUR should be accompanied by the following appendices, as appropriate, numbered as follows: 1. 2. 3. 4. 5. 6. 7. Investigators Brochure; Cumulative Table of Important Regulatory Requests; Status of Ongoing and Completed Trials; Cumulative Summary Tabulations of Demographic Data; Line Listings of Serious Adverse Reactions; Cumulative Summary Tabulation of Serious Adverse Events; Scientific Abstracts (if relevant). TMP-QA-015 V1 (22-8-15) DSUR Report Page 7 of 9 Appendix A- Tables and Table headings for Clinical Trial Listings Table 1 – Overview of Ongoing Studies [Study Drug] Study Phase Country Study Study Dosing Study FVFP† Planned Subject ID Title design regimen Population enrolment exposure‡ †FVFP = first patient first visit ‡ Based upon total numbers of patients recruited as of [date] and applied randomisation schemes. Table 2 – Overview of Studies Completed During the DSUR period [Study drug] Study ID Phase Country Study Title Study design Dosing regimen Study Subject Population exposure per treatment arm (M/F) Table 3 – Examples of Headings for Interval Line Listings of Serious Adverse Reactions Study ID EudraCT number Case ID/Subject number† Country Gender Age Serious Adverse Drug Reactions (SARs) Outcome Date of onsent Time to onset‡ Suspect drug Daily dose Route Formulation Dates of treatment Treatment duration Comments † Study/Centre/patient ‡ ‘Primary’ SAR only TMP-QA-015 V1 (22-8-15) DSUR Report Page 8 of 9
Sours: https://studylib.net/doc/7003464/template-for-the-development-safety-update-report--dsur--...
Pharmacovigilance (PV) training: AE, ADR, case processing, ICSR, PSUR, DSUR PEDAR causality labeling

His arms above his head, as if trying to ward off the strange brown smoke that swirled above him. You paid your last tax, you bastard. Your time has come. - My time is still ahead. It's not your monkey herd that decides that.

You will also like:

After a short pause, Yana added, Has this happened to you before. To publicly describe. Yes, a couple of times, Rose admitted.

1058 1059 1060 1061 1062