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Bethesda's Craig Lafferty has laid out some flamebait by suggesting that The Elder Scrolls V: Skyrim has been developed primarily for consoles.
Like I said before, bethesda are releasing mod tools on day one and on the disc, so frankly port from the consoles or not, it doesn't matter. Because the pc modding community has a hell of a reputation for making the elder scrolls series a much more engaging experience with mods.
Most multi-platform games this generation have lead on the consoles....and you can tell
just know that they are probably perfectly aware that you guys will mod the hell out of the game to make it better so they might as well make it the best experience on the consoles as they can.
It's no surprise imo.
TES has been cutting depth for a while because it wants to go the route of the majority of modern RPGs and "simplify" "streamline" and make itself more "accessible" all the way to the bank.
Although I remain a big fan (mostly due to mods which add that depth back in) the series has lost a bit on the RPG side over the years.


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The Seastreak Nautical
June 15, 2015 // Swedish Midsummer Festival
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This piece is real Sterling Silver, and handcrafted in the USA.
in Sterling Silver .925 quality silver
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The field trip on Oct. 18, 2017
We went to Kyoto and Gion as our field trip!
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At Kanji Museum, we learned the kanji structure and futures by using touch panel display. We were very worried about the weather but the sun was up and everybody had a wonderful day!


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mandel posted a topic in Pit Bikeswell ive had my bike for awhile now but only really rode it in the dry so today i wake up and its hammering down with rain and i think lets go: while i was out my bike was really under performing as id increase the throttle it seemed to just die out pure spluttering or it would just cut out i couldnt figure the prob out untill i got home and started to jet wash the dirty thing and i noticed that while i was reving it to keep the engine from getting soaking it was startin to splutter again so i stopped the jet washer and reved it abit more within 20 secs it was bk to normal i then jet washed all by my air filter ( which i might add faces forward 2 the front wheel) and reved and it would splutter like mad again anyone know how i can stop water and tha getting in? or can i turn my filter around? so it fast backwards? my air filter is pritty much the same as this apart from its just flat no slight cone on it http://cgi.ebay.co.uk/MINI-MOTO-DIRT-K-N-K-N-AIR-FILTER-STACK-MPH-NEW_W0QQitemZ8057378509QQihZ019QQcategoryZ25640QQssPageNameZWDVWQQrdZ1QQcmdZViewItem thx for the help
hey could someone explain tyre sizes for me ? as im kinda confused my current setup is 14" front 12" rear my tubes say summin like 2.50-2.75x14 can i use any 14" or 12" tyre ? or have i gotta match the 2.75 and all tha up? ive seen these http://www.a1mx.co.uk/store/index.php?act=viewProd&productId=292 but again they confused me even more with the 90/100/14 anyone clear this up ill be greatful i really need these better tyres also if anyone knows any decent low priced shops (tha ship to me in uk mainland) other than ebay id be even happier thx mandel
Could use a Little Advice!
mandel posted a topic in Pit Bikeshey I've been searching the net now for alot off info and have read alot about the things im lookin into but i still cant find what im looking for, as u all probably know its typical internet and one site says one thing and another says another lol anyways..... more 2 the point so i was out on the weekend on my 110cc (i think its 125cc cause its fastest 110 ive seen around my area but manual says 110) that i bought off ebay in all fairness ive not had a problem untill i hit a slight ditch while wheeling it across the field and flipped it.... ive included sum photos off the fairings and would appriciate sum help on the following questions Fairings: http://img215.imageshack.us/img215/2913/photo00032ei.jpg http://img509.imageshack.us/img509/6963/photo00045rz.jpg http://img226.imageshack.us/img226/6239/photo00051bt.jpg http://img226.imageshack.us/img226/7530/photo00062jt.jpg Questions: the damage is quite minimal so should i glue it? If yes what glue would you recommend? My m8 had same plastics and used a black glue had to use a silicon gun to use it dried like rubber and very flexy but he forgot the name and lost the tin any ideas? any other way i can repair the plastics without using glue? (i read u could use a soldering iron and sort off smelt the bits 2gether carfully) also another problem altho its not a concern atm as its not 2 difficult 2 fix but i could use sum info below is sum pics off the sprocket....... http://img501.imageshack.us/img501/7884/photo00072az.jpg http://img226.imageshack.us/img226/3292/photo00087el.jpg and the questions: My chain almost cums off everytime i hit wet mud and the back tire spins 2 much any ideas what would be the problem? the sprocket nuts and bolts seem 2 rattle alot hence the pictures above 2 are missing these are becuase they where rounded and had to be remove any idea if i can use anything to stop these moving and never have to worrie about em again? thx for the time and effort taken to reply to these questions yours thankfully Mandel


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amazon Ryzen Threadripper reviews
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After a crewmember is crippled in a battle with the Klingons Captain James Kirk takes the Enterprise to Vulcan, where an experimental treatment under development at the Vulcan Academy of Science promises to return him to health. Also undergoing the treatment is Spock's mother Amanda, who is suffering from a degenerative nerve disease that threatens to end her life. As Kirk, Spock, and Leonard McCoy settle in for an extended stay on Spock's homeworld, an catastrophic failure kills one of the subjects undergoing the treatment. Then a second patient dies, raising an unthinkable question — could there be a murderer on Vulcan?
Jean Lorrah's novel, her first of several contributions to the Star Trek universe, is unusual in several respects. One is its setting, as it is the first to be set on Vulcan. This gives Lorrah an opportunity to offer readers an extended look at life on Vulcan, and it is to her credit that she does not overdo it by making the novel about the arcana of one of the most popular cultures of the Star Trek universe. Given the location, it might be expected that Spock would take center stage in the novel, yet Lorrah surprises once again by making his father Sarek the primary Vulcan in the storyline. This further adds to the novel's appeal, as it gives readers an extended look at a beloved character who had yet to receive the extended focus he would in subsequent novels and TV episodes.
Finally there is the plot of Lorrah's novel, which is a rare bird indeed among Star Trek novels: a murder mystery. Here she develops her setting by introducing several new characters (perfectly understandable, as nobody is going to buy a murderer being one of the familiar faces of the bridge crew) and lets the plot unfold while developing them. This she does over the course of the first half of the book, letting suspects accumulate as the murders take place and the motivations are established. Yet all of this is ruined at the halfway point of the novel, when she tips her hand as to the identify of the murderer, after which the rest of the book lapses into a mundane pattern of chasing red herrings and identifying the guilty party at the very end. It's a disappointing ending for a novel that throughout much of its first half offered an engaging tale of mystery in an unlikely place.


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Maggie MacKay isn't the only person living on the Other Side.
Meet Miss Spell.
Queen of Other Side hospitality, her suite of nightly rooms at the No Spell Hotel is filled with creatures just dying to meet you. But as the old saying goes, you attract more bees with honey, more vampires with B positive. If you can't beat 'em, kill 'em with kindness.
Book One in the Other Side Hospitality spin off series.
Product Details
|Katherine Danley
|Publication date:
|Know Spell Hotel , #1
|Sold by:
|NOOK Book
|Sales rank:
About the Author
Kate Danley began her writing career as an indie author in 2010. Since then, she spent five weeks on the USA Today bestseller list, has been honored with various awards, including the Garcia Award for Best Fiction Book of the Year, and her Maggie MacKay series has been optioned for film and television development. She has won the 2016 Panowski Playwriting Award and her plays have been produced in New York, Chicago, Los Angeles, Houston, and other major cities. She has over 300+ film, television, and theatre credits to her name, and specializes in sketch, improv, and Shakespeare. She wrote sketch for a weekly show in Hollywood and has performed her original stand-up at various clubs in LA. She learned on-camera puppetry from Mr. Snuffleupagus and played the head of a 20-foot dinosaur on an NBC pilot. She lost on Hollywood Squares.


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Nude female offering bearer standing with feet together and balancing a basket on her head with her left hand. The body is carved from a single piece of wood with the arms and basket added. The feet are molded from plaster.
From Deir el-Bersha, tomb 10, shaft A (tomb of Djehutynakht). May 1915: excavated by the Harvard University–Boston Museum of Fine Arts Expedition; assigned to the MFA in the division of finds by the government of Egypt. (Accession Date: March 1, 1921)
Credit Line
Harvard University—Boston Museum of Fine Arts Expedition
Egyptian, Middle Kingdom, late Dynasty 11 – early Dynasty, 2010–1961 B.C.
Object Place for Label
Object Place
Deir el-Bersha, Egypt
Width x height x depth: 8 x 41 x 14 cm (3 1/8 x 16 1/8 x 5 1/2 in.)
Accession Number
Medium or Technique


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I sin senaste bok "Event" diskuterar Zizek Platon och hans tanke om idévärlden som grunden för vår flyktiga och skenbara värld, men vänder på begreppen och menar att det snarare är det flyktiga som konstituerar vår värld:
"This is why – if we return for the last time to love - love has nothing whatsoever to do with an escape into an idealized Romantic universe in which all concrete social differences magically disappear. To refer to Kierkegaard again, 'love believes everything – and yet is never to be deceived' – in contrast to the mistrust which believes nothing and is nevertheless thoroughly deceived. The person who mistrusts others is, paradoxically, in his very cynical disbelief, the victim of the most radical self-deception: as Lacan would have put it, les non-dupes errent – the cynic misses the actuality of the appearance itself, however fleeting, fragile and elusive it is, while the true believer believes appearances, in the magic dimension that 'shines through' an appearance: he sees Goodness in the other where the other himself is not aware of it. Appearance and actuality are here no longer opposed: precisely in trusting appearances, a loving person sees the other the way she effectively is, and loves her for her very foibles, not despite them.
With regard to this point the Oriental notion of the Absolute Void-Substance-Ground beneath the fragile, deceptive appearances that constitute our reality is to be opposed to the notion that it is the ordinary reality that is hard, inert and there, and it is the Absolute that is thorouhly fragile and fleeting. That is to say, what is the Absolute? Something that appears to us in fleeting experiences, say, through the gentle smile of a beautiful person, or even through the warm, caring smile of a person who otherwise may seem ugly and rude – in such miraculuos, but extremely fragile moments, another dimension transpires through our reality. As such, the Absolute is easily corroded; it all too easily slips through our fingers, and must be treated as carefully as a butterfly. In short, the Absolute is a pure Event, something that just occurs – it disappears before it even fully appears. - Slavoj Zizek ("Event", 2014, s 89f.)


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Wimbledon is ready to make a run at the Kentucky Derby.
The promising 3-year-old colt trained by Bob Baffert makes his stakes debut Sunday in the US$600,000 Louisiana Derby, a major step on the road to Churchill Downs on May 1.
"He needs to get some seasoning, and there's nothing like Cajun seasoning," Baffert said after Wimbledon tuned up for the Louisiana Derby with a five-furlong workout Monday at Santa Anita.
Wimbledon, a loser in his first four races, is coming off a smashing eight-length maiden win Feb. 8.
And his tennis-inspired name? The horse is owned by Jim McIngvale, whose Westside Tennis Club in Houston has hosted the US Men's Clay Court Championships and Tennis Masters Cup.
The gray colt will be shipped in from California to challenge a field that features Risen Star winner Gradepoint and stablemate Breakaway. Gradepoint, a winner of three straight races for trainer Neil Howard, is rated seventh in this week's Top 10 Derby Prospects list.
One other top prospect, No. 6 Lion Heart, makes his 3-year-old debut in Saturday's US$200,000 San Rafael Stakes at Santa Anita. Baffert, the three-time Kentucky Derby winning trainer, will send out Consecrate in the San Rafael.
Lion Heart, with regular rider Mike Smith aboard, worked six furlongs in 1:12 4/5 at Santa Anita on Tuesday in his final breeze before the San Rafael. The colt won all three starts at 2, and he hasn't raced since taking the Hollywood Futurity on Dec. 20.
Breakaway and Gradepoint, both owned by William S. Farish, put in final breezes before the 1 1-16th-mile Louisiana Derby. They worked together Tuesday and went six furlongs in 1:14 3/5 at the Fair Grounds.
With many of the other top horses not racing until next weekend, there were no changes in this week's Top 10. Moving into the Keep in Mind category were Silver Minister, winner of the John Battaglia Memorial Stakes, and Smarty Jones, winner of the Southwest Stakes.


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Martin Botha
Books by South African Cinema 1896–2010
Dr Botha is an Associate Professor in the Centre for Film and Media Studies at the University of Cape Town.
He published more than 200 articles, reports and papers on the South African media, including five books on South African cinema, namely Images of South Africa: the rise of the alternative film (1992), Movies Moguls Mavericks: South African cinema: 1979-1991 (1992), Kronieken van Zuid-Afrika: De films van Manie van Rensburg (1997) Jans Rautenbach: Dromer, baanbreker en auteur (2006) and Marginal Lives and Painful Pasts: South African cinema after apartheid (2007).
At the 2009 Ischia Global Film and Music Festival he received a special award for his extraordinary contribution to the South African film industry.
Dr Botha has an in-depth knowledge of South African cinema. He was actively involved in research regarding the restructuring of the South African film industry, as well as film policy that lead to the creation of the South African National Film and Video Foundation (NFVF).
He also served as consultant for the Western Cape Investment and Trade Promotion Agency (WESGRO) regarding the establishment of the Cape Film Commission. He was a member of the Steering Committee of the Cape Film Commission, as well as the Council of the National Film and Video Foundation (1999-2006) and the Board of the Cape Film Commission (1999-2003).
He was also the project leader of an investigation into the establishment of a national statutory body for the administration and funding of the local film industry (July - December 1994) and was one of the writers of the White Paper for the post-apartheid South African film industry.
His is currently working on a history of South African cinema for Intellect.
He was a member of FEPACI's Feasibility Study Steering Committee. He also served on the editorial board of the Journal of African Cinemas.
Since 1991 he has been South Africa's correspondent for International Film Guide.
The Centre for Film and Media Studies is committed to promoting the study of African Cinemas, taking account of the richness and diversity of the film cultures that have emerged from the countries that make up this vast and complex continent. Prof. Botha convenes a third-year course in African Cinemas that introduces students to the work of directors such as Djibril Diop Mambety, Youssef Chahine, Gaston Kabore, Ousmane Sembene and Gillo Pontecorvo. The course examines contemporary issues in African cinemas, including cinema in South Africa during and after apartheid.
He is also the founder of the African Cinema Unit at the Centre for Film and Media Studies.
Send me a message:


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ISLAMABAD: Muttahida Qaumi Movement (MQM) lawmakers staged walk out of the National Assembly on Wednesday opposed to the violent death of party workers in Karachi.
Minister for Inter-Provincial Coordination Riaz Pirzada stated speaker lower house had written letters to the interior minister over reservations of MQM. He included that law and order were provincial matter and MQM was part of Sindh government.


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Zithromax is used to treat many different types of infections caused by bacteria, such as respiratory.Azithromycin is recommended in areas with quinolone-resistant Campylobacter and for the treatment of children and. vomiting, abdominal cramps, tenesmus, or bloody.Consumer Medicine Information (CMI) about Zithromax (Azithromycin) intended for persons living in Australia.Some common azithromycin side effects include vomiting, abdominal pain (or stomach pain), and headache.
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In instance of a presumed overdose with symptoms such as diarrhea, nausea or vomiting,.
Zithromax (Azithromycin) is good for treating many bacterial infections. Can cause abdominal pain, diarrhea, vomiting, and nausea.
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Ford Transit Custom lease
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The ITIL Certification Training has become a standard in IT Service Management. ITIL is a globally recognized framework that represents the procedures, tasks, and checklists that are in general applicable to all IT industry. However, ITIL certification primarily covers IT sector but it has spanned itself into healthcare and higher education.
The eligibility criteria for taking ITIL Certification Training is:
This course can be taken up by the professionals who aspire to learn the fundamentals of ITIL frameworks and implement those to amplify the quality of IT service management. Professionals who hail from following designation can take up ITIL course:
IT Architects, Planners and Consultants.
Database Administrators.
Operations Managers
System Administrators and Analysts
IT Managers/Support teams
Service Delivery Professionals
Quality Analysts
Application Management team/ Development team.
With ITIL Certification training program, a professional can take a good salary hike and the professionals who want to switch into IT industry can also take up this course.
The following gives a glance of benefits of ITIL Certification:
Since the ITIL framework gives a business- view of the functioning of IT department . As more and more organizations adopt ITIL framework, there is huge demand of ITIL Certified professionals.
The ITIL framework:
Manages business risk for the services of an organization
Minimizes Service Disruption
Quantifies and clearly demonstrates the true value of the service that an organization provides.
Standardised Services and Maximum Return on Investment.
- the Marketing and Consumption of the Services of the organization.
Supports business transformation/change keeping the pace with the demand of the customer. Thus, helps in building and maintaining positive relationship with customers.
ITIL helps in forecasts and fast response to demand for services of an organization and positively influences the demand for the services of an organization within the effective costs.
Implementation of ITIL allows IT department to have greater visibility of IT costs and assets which is further helpful in asset utilization and reduction of hidden costs
which ultimately result in hike of Total Cost of Ownership.
With so much advantages from organizational view and view of the professionals who take up ITIL course, the ITIL Certification Training provides a leverage to the growth of the organizations and individuals as well.
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Spider-Man and His Amazing Friend Vs. A Massive Man-Wolf
I confess that I don't watch cartoons much anymore. I still love the stuff from my youth (like SPIDER-MAN AND HIS AMAZING FRIENDS), and always will, but I despise, and I do mean DESPISE, the animation you see in such contemporary programs as PHINEAS AND FERB. It makes me want to smash the television screen, I hate it so much. I was pleasantly surprised recently to discover that they do still make cartoons the way they used to, after all. Disney XD's SPIDER-MAN cartoon is refreshingly old-school in terms of the animation, and the writing isn't dumbed-down like you too often see with such programs. It wasn't with that particular episode, anyway.
The episode I watched involved Spider-Man and the Hulk fighting the Man-Wolf. The latter character was rendered much bigger than he appears in the comics, and John Jamison was returned to his teenage years. He wasn't an astronaut anymore, just a high school Science nerd, and his transformations were powered not by a moon rock but by a stone infused with gamma radiation, like the Hulk. Yes, the Hulk got scratched, and then turned into a werewolf himself, so Spidey sure had his hands full. The werewolves were surprisingly savage, considering it was a kid's show. Hulk-Wolf smash!
WAYNE MILLER is the owner and creative director of EVIL CHEEZ PRODUCTIONS (www.evilcheezproductions.blogspot.com, www.facebook.com/evilcheezproductions), specializing in theatrical performances and haunted attractions. He has written, produced and directed (and occasionally acted in) over a dozen plays, most of them in the Horror and Crime genres. His first novel, THE CONFESSIONS OF SAINT CHRISTOPHER: WEREWOLF, is available for purchase at https://www.smashwords.com/books/view/734763


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ClinicalTrials.gov Why Does it Affect Me? Should I Be Concerned? Presenter Name and contact Info
Be aware that… Any PowerPoint presentation can only be an introduction to a topic. This subject is complex – this will point you to many other resources – and our office is happy to assist you further. PowerPoint bullets are neither the law nor the regulations that apply. 2
Explain what ClinicalTrials.gov is and what it can do Explain why you should register your study o FDAAA o ICMJE o Voluntary (Recruitment etc.) Identify who is responsible for registration Provide practice examples Explain how registration works at YOUR INSTITUTION Help Resources (institutional & national) Learning Objectives 3
What is ClinicalTrials.gov? 4 Why should I be concerned?
http://www.ClinicalTrials.gov 5
Help for Registering Studies on ClinicalTrials.gov "Submit Studies" at http://clinicaltrials.gov/ct2/manage-recs http://clinicaltrials.gov/ct2/manage-recs "For Researchers" at http://clinicaltrials.gov/ct2/help/for- researcher http://clinicaltrials.gov/ct2/help/for- researcher "For Study Record Managers" at http://clinicaltrials.gov/ct2/help/for-manager http://clinicaltrials.gov/ct2/help/for-manager 6
ClinicalTrials.gov can be searched in real time to find enrolling and completed studies including Conditions Interventions Outcome measures Sponsors/collaborators Locations Phases Dates (Start and Completion) Results 7
Rationale Increase research transparency Help people find trials 8 To learn more, visit: http://clinicaltrials.gov/ct2/manage-recs/backgroundhttp://clinicaltrials.gov/ct2/manage-recs/background
Evolution of Clinical Trial Disclosure Requirements 1997:FDAMA establishes ClinicalTrials.gov 2000:ClinicalTrials.gov launched 2005:ICMJE requires registration of trials (including at ClinicalTrials.gov) 2007:FDAAA expands ClinicalTrials.gov to require registration of more studies and results and adds penalties for noncompliance 2008:ClinicalTrials.gov adds basic results modules, including adverse events Source: http://clinicaltrials.gov/ct2/about-site/historyhttp://clinicaltrials.gov/ct2/about-site/history 9
Recent News Place holder slide for YOU to insert recent news about ClinicalTrials.gov 10
Updated from D. Zarin, ClinicalTrials.gov, Overview of ClinicalTrials.gov presentation, December 2008, http://prsinfo.clinicaltrials.gov/webinars/module1/resources/Overview_Handouts.pdf. http://prsinfo.clinicaltrials.gov/webinars/module1/resources/Overview_Handouts.pdf 11
Why should I register a trial in ClinicalTrials.gov? 12
FDA Amendments Act of 2007 (FDAAA) Most prospective clinical trials involving regulated drugs, biological products, and devices must be registered on ClinicalTrials.gov. (The law also requires reporting of results and adverse events for a subset of these studies.) To learn more about FDAAA 801 Requirements, visit: http://clinicaltrials.gov/ct2/manage-recs/fdaaa # 1 It's the law! 13
It's the law (a final detail) Some Phase I trials, though they are not Applicable Clinical Trials under FDAAA, are required to register under FDAMA – the earlier law -- which is still in effect. These involve primarily experimental treatments for serious or life-threatening diseases whether using an IND, Group C Cancer drug, or other FDA regulated product. Thus, many studies for cancer and other serious and life- threatening diseases must register regardless of Phase. For more information: http://prsinfo.clinicaltrials.gov/publications/FDLI-Update_2009_508.pdf 14
FDAAA - Registration Required for "Applicable Clinical Trials": Interventional studies (drugs, biologics, devices) Phase 2 – 4 (not phase 1 drug; not small feasibility device;) US FDA jurisdiction (e.g., IND/IDE or US site) Studies initiated after September 27, 2007, or initiated on or before that date and were still ongoing as of December 26, 2007 When: Within 21 days of enrollment of 1 st subject Update at least every 12 months (30 days for Recruitment Status and Primary Completion Date) http://clinicaltrials.gov/ct2/manage-recs/fdaaa 15
FDAAA – Results Submission Required for: Applicable Clinical Trials In which the study product is approved (for any use) by FDA When: Within 12 months of Primary Completion Date (final data collection for primary endpoint) If product not approved by Primary Completion Date but is approved later, then results due 30 days after approval Delays are possible, primarily for manufacturer or under limited special circumstances o Pending publication is NOT considered a good cause for delay http://clinicaltrials.gov/ct2/manage-recs/fdaaa 16
International Committee of Medical Journal Editors (ICMJE) Requires registration in a publicly available, searchable system. Scope is broader than FDAAA (i.e., all clinical trials). Includes 1000+ journals that have adopted the ICMJE policy, such as BMJ, JAMA, and NEJM. Source: http://www.icmje.org/journals.htmlhttp://www.icmje.org/journals.html #2 You Want to Publish! 17
ICMJE – Registration: Which studies? Required for Prospective studies that: Assign subjects to an intervention or concurrent comparison or control groups Study the cause/effect relationship between medical intervention and a health outcome. ICMJE scope is much broader than the scope of FDAAA: Interventions include procedures, behavioral treatments, dietary interventions Health outcomes include any biomedical or health-related measure obtained in participants, including pharmacokinetic measures and adverse events 18 Source: http://www.icmje.org/publishing_10register.htmlhttp://www.icmje.org/publishing_10register.html
ICMJE - Registration When to register: o Prior to enrollment of 1 st subject ICJME doesn't require results submission ICMJE will not consider results data posted in the tabular format required by ClinicalTrials.gov to be prior publication 19 Source: http://www.icmje.org/publishing_10register.htmlhttp://www.icmje.org/publishing_10register.html
Policy Requirements – Recap (Relative numbers of trials subject to policy) FDAAA Results & AE Reporting ICMJE Registration FDAAA and FDAMA Registration 20
Who is responsible for registering the trial? ICMJE: Anyone can register, but the author is responsible for ensuring complete registration FDAAA: The Responsible Party (RP) defined as… The Sponsor (or Sponsor-Investigator): IND/IDE holder If no IND/IDE, the industry, academic institution or other organization that initiated the study 22
FDAAA: Designation of Responsible Party RP can be designated by the Sponsor to a PI who: Is responsible for conducting the study Has access to and control over the data Has the right to publish the trial results, AND Has the ability to meet the requirements Example of RP designation PI initiated study at "Your U" funded by NHLBI o "Your U" is the Sponsor (grant funding recipient) o "Your U" can be the RP or designate the PI as the RP Note: even if not designated as RP, the PI can still enter data into ClinicalTrials.gov 23
Who is the RP? (Let's practice) 1.Department funded/ PI initiated research 2.NIH funded research/ "Your U" is the grantee institution 3.Pharmaceutical company funded research/ multi- center study including site at "Your U" 4.Device company funded research/ "Your U" PI is the IDE holder 5.Cooperative Group study 24
25 What happens if I don't register?
Consequences of Noncompliance FDAAA Public notices of noncompliance and violations Withholding of NIH funds FDA sanctions Civil monetary penalties (up to $10,000/day) ICMJE Cannot publish in journals following ICMJE policy, and other select journals 26
What are my responsibilities for the following studies? Hmmm… 27
Study #1 Effectiveness of Bupropion for Treating Nicotine Dependence in Young People Study Design: Multi-center, Randomized, Efficacy Study Interventions: Bupropion, Placebo Primary Outcome: Smoking behavior over 6 months Register? For FDAAA? For ICMJE? Results? Responsible Party? 28
Study #2 Effects of Chronic Sleep Restriction in Young and Older People Study Design: Open label, Crossover Assignment Interventions: Chronic sleep restriction Primary Outcome: Changes in sleep and waking EEG measures, frequent measures of performance, attention, alertness Other fact: Two universities collaborating, Dr. A @ AU and Dr. B at BU; Dr. B designed study, but A will enroll more Register? For FDAAA? For ICMJE? Results? Responsible Party? 29
Study #3 Assess the impact on Quality of Life (QoL) of long term caregivers of patients with multiple sclerosis. Centers/sample size: Multi-site, 450 subjects Intervention/method: Caregivers take QoL survey monthly for 2 years Other fact: Funded by Pharmaceutical Co. Register? For FDAAA? For ICMJE? Results? Responsible Party? 30
Study #4 Implantable device designed to relieve the symptoms of heart failure through counter-pulsation technology. Study Design: Open Label Intervention: Implantable device (IDE obtained) Primary outcome: to test the feasibility of the device 8 people enrolled, 6 month study Register? For FDAAA? For ICMJE? Results? Responsible Party? 31
Study #5 Dental graduate student is the investigator for a medical device study. Study Design: Randomized Intervention: Treatment with 1 of 3 different FDA approved medical devices Primary Outcome: Which device increases fluoride in saliva the most? Register? For FDAAA? For ICMJE? Results? Responsible Party? Who will follow up when she graduates? 32
Study #6 – Last one Hip Fracture Study Method: Compile data from electronic medical record (EMR) over a two year period for 1700 subjects Data elements: smoking status, use of alcohol, bone marrow density, weight, and height Primary Outcome: Determine the validity of a new hip fracture risk assessment method compared to FRAX, World Health Organization's fracture risk tool Register? For FDAAA? For ICMJE? Results? Responsible Party? 33
What is the FDAAA requirement for informed consent language? 34
Informed Consent Language FDA Mandated Changes in Consent Form Language The FDA has added a new element of consent that is required for "applicable clinical trials." All applicable clinical trials are required to include this new element of consent by March 7, 2012. By federal regulation, the required language must be incorporated verbatim and cannot be altered in any way. "A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by US law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time."www.ClinicalTrials.gov Subjects who were consented before March 7, 2012 will NOT have to be re-consented or otherwise sign addendum consent with this language. For more information or questions, contact the "YOUR U" IRB office or office of regulatory affairs. 35
"As required by law" Note: you should only include that section if the trial is an "applicable clinical trial" required by law to post in ClinicalTrials.gov. If not, do not use this language. Guidance for Sponsors, Investigators, and Institutional Review Boards Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c) (Small Entity Compliance Guide) Feb. 2012 Nonbinding on government! 36
Reasons to Register & Use Informed Consent Language FDAAA Results & AE Reporting ICMJE Registration FDAAA and FDAMA Registration Looking for Participants 37
38 What if I have more questions?
Additional Resources General ClinicalTrials.gov information: http://clinicaltrials.gov/ct2/about-site http://clinicaltrials.gov/ct2/about-site FDAAA related information: http://clinicaltrials.gov/ct2/manage-recs/fdaaa http://clinicaltrials.gov/ct2/manage-recs/fdaaa For specific questions or comments: email@example.com@clinicaltrials.gov Office of Extramural Research (OER): http://grants.nih.gov/Clinicaltrials_fdaaa/ http://grants.nih.gov/Clinicaltrials_fdaaa/ Frequently Asked Questions for NIH Grantees: http://grants.nih.gov/Clinicaltrials_fdaaa/faq.htm http://grants.nih.gov/Clinicaltrials_fdaaa/faq.htm Instructions for Authors sections of ICMJE journals all have information regarding clinical trial registration Local Contacts: – ADD "YOUR U" contacts here or on a final slide 39
This slide set was made possible by a collaboration of CTSA organizations (Mayo Clinic, Partners, University of Michigan Medical School, University of Rochester) and the National Library of Medicine. The Clinical and Translational Science Awards Program (CTSA) is part of the Roadmap Initiative, Re-Engineering the Clinical Research Enterprise and is funded by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH). 40
ICMJE changes 2005 41
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> Tha Chang
We have 2 hotels in Tha Chang.
Phuendernthang Resort
15/1 Moo 6 T.lamet A.Chaiya Suratthani
Phuendernthang Resort offers a comfortable setting while in Tha Chang. It also provides meeting rooms, a coffee bar and room service.On-site dining options include a restaurant, which is an ideal place to enjoy a meal.
Happy House Resort
41 Moo 6 Tambon Lamet Amphur Chai Ya
Happy House Resort provides a comfortable setting when in Tha Chang.Happy House Resort has cosy rooms, furnished to fit the requirements of any traveller.The guest house is under a 25-minute drive from Surat Thani Airport.
More on Tha Chang .
Tha Chang is a district in the west of Surat Thani Province of southern Thailand.


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