改ざんとは

改ざんとは

昨今、当局における改ざんの問題が世間をにぎわしている。
しかしながら「改ざん」の定義について正確に理解されていないケースが多い。

「改ざん」は悪意のある不正行為であると理解している人が多いようである。
実はそうではない。

「改ざん」は、文書、記録等の全部又は一部が、本来なされるべきでない時期に、本来なされるべきでない形式や内容などに変更されること、すること、をいう。故意の場合も過失の場合もともに含み、悪意の有無を問わない。
「改ざん」という概念は、悪意が無い場合も含んでおり、たとえばその変更が不適切であるか否かが厳密に定義できる分野では、悪意がなくても誤解や知識不足によって不適切な変更を行った場合や、パソコンの誤操作等の事故による意図的でない変更は「改ざん」にあたる。

データインテグリティと改ざんについて

データインテグリティの目的の一つとして、データが改ざんされていないことを保証することがあげられる。
患者の安全性にとって、故意によるデータの改ざんも入力ミスや転記ミスといった事故による改ざんも等しく問題となる。
多くのデータインテグリティに関するセミナーや書籍においては、悪意のある不正な改ざんに焦点が当たり過ぎている感がある。
しかしながら、不正による改ざんがそんなに多い訳ではない。
製薬企業として確立し対応しなければならないのは、不正よりも悪意のない改ざんである。

悪意のない改ざんには、故意による改ざんと非故意による改ざんに分類される。
前者は、手順書を理解していなかったり、思い込みにより悪意はないもののわざとデータを変更してしまう事案である。本人が気づくことなく日常的な違反を繰り返してしまう。
後者は不注意によるデータ入力ミスや転記ミスなどがあげられる。

一般に故意による改ざんは全体の20%を占め、非故意による改ざんは全体の80%を占めるといったデータもある。

医薬品の有効性と安全性を担保するためには、不正による改ざんよりも、悪意のない改ざんを防ぐ必要があり、知らず知らずに起こしてしまう非故意による改ざんを防止することが喫緊の課題であると言える。

データインテグリティに関する規程・手順書

イーコンプレスでは「データインテグリティ規程・手順書」のひな形の販売を開始いたしました。

データインテグリティ規程・手順書  55,000円(税込)

【目次】
データインテグリティ規程

1. 目的
2. 適用範囲
3. 用語の定義
4. 背景
5. データインテグリティの原則
6. データガバナンス
6.1 データインテグリティのためのステップ
6.1.1 教育およびコミュニケーション
6.1.2 リスクの発見および低減
6.1.3 技術およびITシステム
6.1.4 データガバナンス
7. 手順書等
8. 参考
9. 付則


データインテグリティ手順書

1. 目的 
2. 適用範囲 
3. 用語の定義 
4. 役割と責任 
5. 啓発活動 
6. 教育訓練 
7. 関連する手順書の改訂 
 7.1 リスクマネジメント 
   7.1.1 リスクの検討 
   7.1.2 リスク低減策の検討 
   7.1.3 リスク低減策の実施 
 7.2 データライフサイクル 
   7.2.1 データの作成 
   7.2.2 データの処理 
   7.2.3 データのレビュ・報告・使用 
   7.2.4 データの保管・維持 
8. コンピュータシステムの見直し、導入 
9. 監視・測定 
10. 監視・測定 
11. 記録の保管 
12. 参考 
13. 付則 


ご購入は こちら

Related post

Comment

  1. A motivating discussion is worth comment. I believe that you ought to write
    more on this subject, it may not be a taboo subject but usually people don’t
    talk about such subjects. To the next! Many thanks!!

  2. Hi, Neat post. There’s an issue together with your web site in internet explorer, may test this?

    IE nonetheless is the marketplace chief and a
    large component of other people will leave out your excellent writing due
    to this problem.

  3. Hi there! Quick question that’s entirely off topic. Do you know how to make your site mobile friendly?
    My blog looks weird when viewing from my iphone4.
    I’m trying to find a theme or plugin that might be able to fix this problem.
    If you have any suggestions, please share. Many thanks!

  4. At this moment I am going away to do my breakfast, once having my breakfast coming over again to
    read more news.

  5. It’s a pity you don’t have a donate button! I’d most certainly donate to this superb blog!
    I suppose for now i’ll settle for bookmarking and adding your RSS feed to my Google
    account. I look forward to new updates and will talk about
    this website with my Facebook group. Talk soon!

  6. Whoa! This blog looks just like my old one! It’s on a completely different topic but it has pretty
    much the same layout and design. Wonderful
    choice of colors!

  7. https://solo.to/kobet1

  8. https://www.outlookindia.com/plugin-play/ED8590ED8590EBB2B3-EB8F99EC9DBC-EC8694EBA3A8EC8598-EBA994EC9DB4ECA080EC82ACEC9DB4ED8AB8-EBAAA8EC9584EBB3B4EAB8B0

  9. http://www.genebiotech.co.kr/bbs/board.php?bo_table=free&wr_id=2413225

  10. http://daoad.kr/bbs/board.php?bo_table=free&wr_id=62777

  11. https://bkmobile.biz/bbs/board.php?bo_table=free&wr_id=93045

  12. http://www.arkmusic.co.kr/bbs/board.php?bo_table=free&wr_id=1404648

  13. https://yic.co.kr/bbs/board.php?bo_table=free&wr_id=398936

  14. http://mdcs.co.kr/bbs/board.php?bo_table=free&wr_id=18193

  15. I’m extremely inspired together with your writing
    talents and also with the format in your weblog.
    Is that this a paid theme or did you modify it yourself?

    Either way stay up the nice quality writing, it’s rare to look a nice weblog like this one nowadays..

  16. hi!,I love your writing very a lot! proportion we keep up a correspondence extra approximately your post on AOL?
    I need an expert on this area to solve my problem. May be
    that’s you! Taking a look ahead to look you.

  17. Howdy would you mind sharing which blog platform you’re using?
    I’m looking to start my own blog in the near future but I’m
    having a tough time deciding between BlogEngine/Wordpress/B2evolution and Drupal.

    The reason I ask is because your design and style seems different then most blogs and I’m
    looking for something unique. P.S Apologies for being off-topic but I had
    to ask!

  18. I visited multiple blogs but the audio feature for audio songs current at this website is actually superb.

  19. Thank you for the auspicious writeup. It in fact was a amusement account it.
    Look advanced to more added agreeable from you!
    By the way, how can we communicate?

  20. You’re so awesome! I don’t believe I’ve read
    something like that before. So good to discover somebody with a few original thoughts on this subject.
    Really.. thank you for starting this up. This website is one thing that’s needed on the web, someone with some originality!

  21. Hi, i think that i saw you visited my web site so i came to “return the favor”.I am attempting to find things to enhance my web site!I suppose its ok to use some of your ideas!!

  22. Hey there! Do you know if they make any plugins to help with SEO?

    I’m trying to get my blog to rank for some targeted keywords but I’m not seeing very good
    success. If you know of any please share. Thanks!

  23. http://downtown21.com/bbs/board.php?bo_table=free&wr_id=205596

  24. I couldn’t resist commenting. Perfectly written!

  25. Hi there, its nice piece of writing about media print, we all be aware of
    media is a impressive source of information.

  26. If you desire to improve your experience only keep visiting this site and
    be updated with the hottest news posted here.

  27. My spouse and I absolutely love your blog and find almost all
    of your post’s to be exactly I’m looking for. Does one offer guest writers to
    write content in your case? I wouldn’t mind creating a post
    or elaborating on some of the subjects you write in relation to here.
    Again, awesome site!

  28. A motivating discussion is worth comment. I do think that you ought to publish more on this issue, it may not be a taboo
    matter but generally people do not talk about such subjects.
    To the next! Cheers!!

  29. Thank you for sharing your info. I truly appreciate your efforts and I am waiting for your
    further write ups thank you once again.

  30. Hey there would you mind stating which blog platform you’re working with?
    I’m looking to start my own blog in the near future but I’m having a difficult time deciding
    between BlogEngine/Wordpress/B2evolution and Drupal. The
    reason I ask is because your layout seems different then most blogs and I’m looking
    for something unique. P.S Apologies for getting off-topic but
    I had to ask!

  31. Quality content is the secret to be a focus for the viewers to pay
    a quick visit the web page, that’s what this website is
    providing.

  32. Oh my goodness! Impressive article dude! Thank you so much, However I am
    experiencing issues with your RSS. I don’t know the
    reason why I am unable to subscribe to it.
    Is there anybody having similar RSS issues? Anybody who knows the answer will you kindly respond?
    Thanx!!

  33. Good post. I learn something totally new and challenging on blogs I stumbleupon every day.
    It’s always useful to read through content from other authors and use something from other web sites.

  34. This site truly has all the info I wanted about this subject and didn’t know who to ask.

  35. Every weekend i used to visit this web site, for
    the reason that i wish for enjoyment, since this this web site conations in fact nice funny stuff too.

  36. Awesome blog! Do you have any helpful hints for aspiring writers?
    I’m hoping to start my own blog soon but I’m a little lost on everything.
    Would you recommend starting with a free platform like WordPress or go
    for a paid option? There are so many options out there that
    I’m completely overwhelmed .. Any recommendations?
    Thanks a lot!

  37. Hello! I’m at work surfing around your blog from
    my new iphone 3gs! Just wanted to say I love reading your blog and look forward to all your posts!
    Carry on the fantastic work!

  38. I just could not go away your website before suggesting
    that I really loved the standard information an individual
    provide to your visitors? Is going to be again often in order to check out new posts

  39. Do you have a spam problem on this blog; I also am a blogger,
    and I was wanting to know your situation;
    many of us have developed some nice procedures and we are looking to exchange methods with
    other folks, be sure to shoot me an e-mail if interested.

  40. I know this site gives quality dependent articles and extra data, is there any other web page which offers these data
    in quality?

  41. Hi are using WordPress for your blog platform? I’m new to the blog world but I’m
    trying to get started and create my own. Do you require any html coding
    knowledge to make your own blog? Any help would be greatly appreciated!

  42. Every weekend i used to pay a quick visit this web site, because i
    wish for enjoyment, since this this web page conations genuinely good funny material too.

  43. Great post.

  44. Hello there! This blog post could not be written much better!
    Reading through this post reminds me of my previous roommate!
    He constantly kept talking about this. I’ll forward this post to him.
    Fairly certain he’s going to have a very good read.
    Thanks for sharing!

  45. Someone essentially help to make significantly articles I
    would state. This is the first time I frequented your web page and up to now?

    I surprised with the research you made to create this particular put up extraordinary.
    Wonderful task!

  46. Everything is very open with a very clear description of the issues.
    It was truly informative. Your website is very helpful.

    Thanks for sharing!

  47. Very good post! We are linking to this particularly
    great post on our website. Keep up the good writing.

  48. Hey I know this is off topic but I was wondering if you knew of any widgets I could add to my blog that automatically tweet my newest
    twitter updates. I’ve been looking for a plug-in like this for quite some time
    and was hoping maybe you would have some experience with something like this.
    Please let me know if you run into anything. I truly enjoy reading your blog and I
    look forward to your new updates.

  49. Heya! I just wanted to ask if you ever have any problems with hackers?
    My last blog (wordpress) was hacked and I ended up losing many months of hard work due to no back up.
    Do you have any solutions to protect against
    hackers?

  50. I think what you said made a great deal of sense. But, what about this?
    suppose you typed a catchier post title? I mean, I don’t wish to tell you how to run your blog, but what if you added a title that
    grabbed folk’s attention? I mean 改ざんとは | お役立ち情報 is a little plain. You might look at Yahoo’s home page and note how they create news titles to grab people
    to open the links. You might add a video or a related pic
    or two to grab people excited about what you’ve written. Just my opinion, it could
    make your posts a little bit more interesting.

  51. I was excited to uncover this site. I want to to thank you for ones time just for this fantastic read!!

    I definitely enjoyed every part of it and I have you book-marked to
    check out new information in your site.

  52. I think this is among the most significant info for me.
    And i am glad reading your article. But want to remark on some general things, The
    site style is wonderful, the articles is really excellent :
    D. Good job, cheers

  53. This design is wicked! You obviously know how to keep a reader amused.
    Between your wit and your videos, I was almost moved to start my own blog (well, almost…HaHa!) Fantastic job.
    I really enjoyed what you had to say, and more than that,
    how you presented it. Too cool!

  54. This is my first time pay a visit at here and i
    am truly pleassant to read everthing at one place.

  55. hello!,I love your writing very a lot! proportion we communicate extra approximately
    your article on AOL? I require a specialist in this house to resolve
    my problem. Maybe that’s you! Taking a look ahead to look you.

  56. Incredible! This blog looks exactly like my old one! It’s on a entirely different subject
    but it has pretty much the same layout and design. Excellent choice of colors!

  57. Heya i’m for the primary time here. I found this board and I
    to find It really helpful & it helped me out
    a lot. I am hoping to give one thing again and aid others such as you helped me.

  58. What’s up, the whole thing is going well here and ofcourse
    every one is sharing data, that’s truly excellent, keep up writing.

  59. Right now it looks like Drupal is the top blogging platform
    out there right now. (from what I’ve read) Is
    that what you are using on your blog?

  60. If you are going for best contents like me, just go to see this website daily
    for the reason that it provides quality contents, thanks

  61. May I just say what a relief to discover an individual who
    really understands what they are discussing on the net.
    You actually understand how to bring a problem to light and make it important.

    A lot more people really need to read this and understand
    this side of the story. I was surprised that you aren’t more popular because
    you definitely possess the gift.

  62. Hi! I know this is sort of off-topic but I had to ask.

    Does operating a well-established website such as yours require
    a large amount of work? I’m completely new to blogging however I do write in my diary daily.
    I’d like to start a blog so I can share my own experience and thoughts online.
    Please let me know if you have any ideas or tips for
    new aspiring blog owners. Thankyou!

  63. Valuable info. Fortunate me I discovered your website by chance,
    and I am surprised why this twist of fate did not happened earlier!
    I bookmarked it.

  64. whoah this blog is excellent i really like studying your articles.
    Stay up the good work! You realize, many persons are looking around for this info, you can aid them greatly.

  65. Every weekend i used to pay a visit this web page, for the
    reason that i wish for enjoyment, for the reason that this this
    site conations really nice funny material too.

  66. Pretty nice post. I just stumbled upon your weblog and wanted to say that I’ve
    truly enjoyed browsing your blog posts. In any case I’ll be subscribing to your
    feed and I hope you write again soon!

  67. Spot on with this write-up, I honestly believe this web
    site needs far more attention. I’ll probably
    be returning to see more, thanks for the information!

  68. Thank you, I have just been searching for info about this subject
    for a long time and yours is the best I’ve found out so far.
    However, what about the bottom line? Are you certain about the
    supply?

  69. I’m impressed, I have to admit. Seldom do I encounter a blog that’s both educative and interesting, and without a doubt, you have hit the nail on the head.
    The problem is something too few men and women are speaking intelligently about.
    I’m very happy I stumbled across this in my search for something concerning this.

  70. I’m not sure exactly why but this blog is loading extremely slow for me.
    Is anyone else having this issue or is it a problem on my end?
    I’ll check back later on and see if the problem still exists.

  71. I am really enjoying the theme/design of your blog. Do you ever run into
    any internet browser compatibility problems? A number of my blog visitors
    have complained about my website not working correctly in Explorer but looks great in Firefox.
    Do you have any recommendations to help fix this issue?

  72. Superb, what a blog it is! This webpage provides valuable facts to us, keep
    it up.

  73. Hey There. I found your blog using msn. This is a very well written article.
    I’ll make sure to bookmark it and return to read more of
    your useful information. Thanks for the post.
    I’ll certainly comeback.

  74. http://www.bioguard.kr/bbs/board.php?bo_table=free&wr_id=43309

  75. Hey I am so grateful I found your weblog, I really found you by mistake, while I was
    looking on Google for something else, Regardless I am here now and would just like to say cheers for
    a incredible post and a all round enjoyable blog (I also
    love the theme/design), I don’t have time to read through it all at the
    minute but I have saved it and also included your RSS
    feeds, so when I have time I will be back to read a lot more, Please do keep up the excellent work.

  76. I delight in, cause I found just what I was having a look for.
    You’ve ended my 4 day lengthy hunt! God Bless you man. Have
    a nice day. Bye

  77. You really make it seem so easy with your presentation but
    I find this matter to be really something which I think I would never understand.
    It seems too complicated and very broad for me. I’m looking forward
    for your next post, I will try to get the hang of it!

  78. Hi there, its fastidious article concerning media print, we all be familiar with media is a great source of facts.

  79. Heya i am for the first time here. I came across this board and I find It really useful & it helped me out much.
    I hope to give something back and help others like you aided me.

  80. I was able to find good information from your blog posts.

  81. https://rentry.co/k3m6po8n

TOP