生データにおける動的電子記録と静的電子記録について

生データとは

生データの定義はFDAのGLP規則である21 CFR Part 58.3(k)に記載がある。

“生データ”とは、実験室内のワークシート記録書、覚え書き、注意書き、またはその正確なコピーをいい、これは非臨床試験の原観察結果およびその業務についての成績であり、この試験の報告の再構成および評価のために必要である。
生データの正確な転写（例えば、そのまま転写され、日付をつけ、署名によって正確であると確認されたテープ）が用意された場合には、その正確なコピーまたは正確な転写を生データとしてもとの資料と置き換えることができる。生データは写真、 マイクロフィルムまたはマイクロフィッシュ、コンピュータ記録、観集結果を口述した磁気記録および自動装置から記録されたデータでもさしつかえない。”

つまりそれ以前に記録がなく、初めて記録されたものが生データである。
しかしながら、感熱紙などに記録が印刷される場合、そのままでは経年劣化し茶けてしまう。
その場合、正確なコピー（またはスキャン）をとり、コピーをした人の署名、日付を付すことによって生データに置き換えることができる。
このような生データの正確な転写を”True Copy”または”Certified Copy”と呼ぶ。

動的電子記録と静的電子記録

動的電子記録とは例えば動画（ビデオ）である。静的電子記録とは例えば静止画像（写真）や紙コピー である。
静的電子記録（写真や紙コピー）が生データとなる場合は多くある。
しかしながら、生データがビデオ（例：スモッグテストの記録）である場合、その1シーンを切り出した写真は”True Copy”とはならない。したがって生データではない。

クロマトグラムのバイナリーデータ（動的電子記録）は、再解析が可能でベースラインや隠れている領域を拡大してみることができる。
しかしながら、紙媒体に印刷したチャート（静的データ）ではそれらの操作が不可能である。
したがって、規制当局はクロマトグラムのチャートは生データまたは”True Copy”とは認めない。

本邦においては、クロマトグラムのチャート（印刷）を生データとして保存し、バイナリデータを破棄しているケースが多くみられる。しかしながら、FDAやMHRAなどの規制要件では、クロマトグラムのチャート（印刷）は生データとは認めないので注意が 必要である。
バイナリデータは決して削除してはならないのである。

ちなみに、クロマトグラフィに相等するデータベース形式の動的電子記録であれば、データを追跡調査、傾向調査、クエリーすることができ、適切なアクセス権限があれば、レビュワーは再解析し、隠れたフィールドを表示し、ベースラインを引き延 ばし積分をさらに詳細に見ることができる。

動的電子記録の”True” Copyは、オリジナル記録の内容と意味が保存され、適切なリーダーと複写装置（例、メディアリーダーを含むソフトウェアやハードウェア）が容易に入手可能であることが条件で、オリジナル記録の形式あるいは互換性のある形式で作成し維持することが できなければならない（§211.180（d）、§212.110）。

Related post

Comment

  1. skin allergy tablets list best non prescription allergy medication best allergy over the counter

  2. super strong sleeping pills meloset ca

  3. buy prednisone 5mg pill prednisone 20mg brand

  4. otc med for stomach cramps buy famotidine cheap

  5. best pills to treat acne buy retin without prescription how do dermatologists treat acne

  6. what is allergy medicine called fml-forte online order strongest over the counter allergy

  7. vomiting medicine name list buy allopurinol 300mg without prescription

  8. oral isotretinoin 10mg accutane us accutane online buy

  9. amoxicillin 1000mg generic buy amoxil 1000mg without prescription amoxil pills

  10. buy sleeping tablets online usa buy sleeping tablets online uk

  11. order azithromycin 250mg pill zithromax 500mg generic buy cheap generic zithromax

  12. buy gabapentin generic gabapentin pills

  13. purchase azipro online cheap purchase azithromycin without prescription buy azipro 250mg pills

  14. purchase lasix generic buy lasix generic

  15. order prednisolone 10mg pill buy prednisolone 40mg generic cheap omnacortil generic

  16. buy generic amoxicillin 500mg amoxicillin 250mg oral cheap amoxil 1000mg

  17. order acticlate for sale buy monodox online

  18. albuterol order ventolin uk purchase albuterol generic

  19. order augmentin 375mg pills cheap augmentin 625mg

  20. levothroid order online cheap levoxyl pill levoxyl online

  21. Thank you ever so for you blog. Really looking forward to read more.
    My website: порно русское с разговорами износ

  22. levitra order online generic vardenafil 10mg

  23. order serophene without prescription order clomid 50mg generic generic clomiphene

  24. buy tizanidine generic buy cheap generic tizanidine tizanidine over the counter

  25. Thank you ever so for you blog. Really looking forward to read more.
    My website: изнасиловал

  26. I gotta favorite this site it seems very beneficial handy
    My website: массаж порно

  27. Major thanks for the article post. Much thanks again.
    My website: порно за зачет

  28. I gotta favorite this site it seems very beneficial handy
    My website: русский секс массаж

  29. Thank you ever so for you blog. Really looking forward to read more.
    My website: русские порно сайты

  30. A lot of blog writers nowadays yet just a few have blog posts worth spending time on reviewing.
    My website: русский порно учитель

  31. A lot of blog writers nowadays yet just a few have blog posts worth spending time on reviewing.
    My website: порно на русском бесплатно без регистрации

  32. order rybelsus 14mg semaglutide 14mg ca purchase rybelsus online

  33. buy deltasone 40mg prednisone 20mg us prednisone without prescription

  34. A lot of blog writers nowadays yet just a few have blog posts worth spending time on reviewing.
    My website: порно по категориям на русском языке

  35. isotretinoin 10mg usa accutane 10mg without prescription order accutane

  36. Respect to post author, some fantastic information
    My website: массаж порно русское

  37. buy semaglutide 14 mg sale semaglutide 14 mg drug order generic semaglutide 14mg

  38. Definitely, what a great blog and revealing posts, I definitely will bookmark your site. Best Regards!
    My website: секс русские студенты

  39. As a Newbie, I am always searching online for articles that can help me. Thank you
    My website: русское реальное порно пьяных баб смотреть

  40. As a Newbie, I am always searching online for articles that can help me. Thank you
    My website: эротика русская пьяные бесплатно

  41. I reckon something truly special in this website.
    My website: порно пьяная

  42. cheap ventolin 2mg ventolin inhalator cost buy albuterol without prescription

  43. Very good post.Really looking forward to read more. Great.
    My website: секс пьяных

  44. cheap amoxil amoxicillin 250mg drug buy amoxicillin pills

  45. augmentin over the counter cost augmentin amoxiclav over the counter

  46. I’m extremely pleased to discover this website. I wanted to thank you for ones time just for this fantastic read!
    My website: девушка писает в рот

  47. zithromax 500mg price zithromax price order zithromax pill

  48. A round of applause for your article. Much thanks again.
    My website: смотреть эротический массаж

  49. levothyroxine generic synthroid 75mcg over the counter levoxyl us

  50. Thanks for sharing, this is a fantastic blog post.Really thank you! Much obliged.
    My website: доктор лесбиянка

  51. cheap prednisolone sale cheap omnacortil without prescription prednisolone us

  52. A lot of blog writers nowadays yet just a few have blog posts worth spending time on reviewing.
    My website: порно пасынок кончил в мачеху

  53. buy clomiphene 50mg online order clomid 50mg pills order clomiphene without prescription

  54. gabapentin 800mg tablet order generic neurontin 100mg neurontin 100mg us

  55. I got what you intend,bookmarked, very decent website.
    My website: порно с красивой брюнеткой

  56. buy lasix 100mg for sale furosemide 40mg cheap buy furosemide 40mg online cheap

  57. Respect to post author, some fantastic information
    My website: большие красивые сиськи

  58. buy generic sildenafil 100mg sildenafil in usa viagra 100mg for sale

  59. Thank you ever so for you blog. Really looking forward to read more.
    My website: порно писсинг в рот

  60. doxycycline brand doxycycline uk buy monodox for sale

  61. semaglutide for sale semaglutide cheap purchase rybelsus without prescription

  62. My website: ебут в жопу на кастинге

  63. free online poker games online blackjack best online gambling for real money

  64. order levitra generic vardenafil cheap order vardenafil for sale

  65. I am incessantly thought about this, thanks for posting.
    My website: секс кончил на лицо

  66. buy pregabalin 150mg online order pregabalin buy cheap generic lyrica

  67. plaquenil 200mg pill hydroxychloroquine cheap cost plaquenil 200mg

  68. As a Newbie, I am continuously exploring online for articles that can be of assistance to me.
    My website: порно дрочит ногами

  69. triamcinolone 10mg for sale aristocort 10mg drug buy triamcinolone tablets

  70. cialis 20mg for sale cialis 10mg for sale tadalafil otc

  71. Very good post.Really looking forward to read more. Great.
    My website: жесткое порно онлайн

  72. cost desloratadine 5mg clarinex 5mg for sale order generic desloratadine 5mg

  73. Ponto IPTV a melhor programacao de canais IPTV do Brasil, filmes, series, futebol
    My website: девушки двойной анал

  74. order cenforce without prescription buy cenforce generic buy cenforce no prescription

  75. Thank you ever so for you blog. Really looking forward to read more.
    My website: смотреть порно анал

  76. loratadine canada buy generic loratadine online buy loratadine 10mg

  77. chloroquine order aralen 250mg cost buy chloroquine online cheap

  78. Thanks for sharing, this is a fantastic blog post.Really thank you! Much obliged.
    My website: натуральная упругая грудь

  79. order generic dapoxetine 60mg order misoprostol 200mcg online buy cytotec tablets

  80. order metformin 1000mg generic buy glycomet generic order glycomet 1000mg generic

  81. Ponto IPTV a melhor programacao de canais IPTV do Brasil, filmes, series, futebol
    My website: порно трахнул блондинку

  82. order xenical 120mg for sale diltiazem oral buy diltiazem 180mg for sale

  83. buy generic lipitor buy lipitor without prescription cost lipitor 20mg

  84. zovirax 400mg pill allopurinol 300mg usa order allopurinol 100mg generic

  85. amlodipine 10mg cost generic amlodipine norvasc 5mg uk

  86. zestril online buy order zestril 2.5mg pills prinivil price

  87. buy rosuvastatin 10mg online cheap purchase zetia generic how to get zetia without a prescription

  88. order prilosec online omeprazole us omeprazole pills

  89. order motilium domperidone canada buy tetracycline paypal

  90. buy lopressor 50mg pill buy metoprolol online cheap metoprolol for sale online

  91. buy generic flexeril buy cyclobenzaprine paypal order ozobax pills

  92. purchase toradol pill purchase colcrys online cheap gloperba sale

  93. order atenolol pills atenolol cost tenormin 100mg uk

  94. depo-medrol otc methylprednisolone 8 mg without prescription depo-medrol medicine

  95. inderal brand buy inderal 10mg for sale clopidogrel 150mg pills

  96. essay writing sites write essays for money pay for essay

  97. purchase methotrexate generic purchase coumadin generic warfarin where to buy

  98. order meloxicam 15mg purchase mobic for sale generic celebrex 200mg

  99. metoclopramide 20mg usa cost metoclopramide 10mg order cozaar 50mg generic

  100. order nexium for sale topiramate 200mg us buy topamax online cheap

  101. where can i buy flomax buy celebrex pills buy celecoxib 200mg online

  102. buy ondansetron medication spironolactone 100mg usa order spironolactone 100mg online cheap

  103. buy sumatriptan for sale sumatriptan sale buy levaquin tablets

  104. brand simvastatin 10mg buy valtrex generic valtrex oral

  105. buy dutasteride cheap order zantac 150mg generic order ranitidine pills

  106. ampicillin antibiotic online how to buy acillin buy amoxicillin medication

  107. cheap propecia 1mg order proscar buy fluconazole 200mg pill

  108. ciprofloxacin 1000mg generic – how to get septra without a prescription order amoxiclav pills

  109. buy ciprofloxacin 500mg pills – buy keflex online amoxiclav pill

  110. order ciplox 500mg online – chloramphenicol online order erythromycin 250mg brand

  111. metronidazole 200mg generic – buy terramycin 250 mg online cheap azithromycin 500mg without prescription

  112. ivermectin 3mg for humans for sale – purchase aczone online buy sumycin online cheap

  113. valacyclovir 1000mg drug – buy nemasole generic purchase acyclovir sale

  114. oral flagyl 200mg – purchase azithromycin buy azithromycin 500mg pills

  115. ampicillin order online order generic acticlate amoxil pill

  116. buy lasix generic diuretic – buy warfarin 2mg without prescription buy capoten for sale

  117. oral metformin 1000mg – order glucophage 500mg online buy lincomycin online cheap

  118. buy zidovudine online pill – order rulide 150mg pill order zyloprim 100mg online

  119. buy clozapine – tritace price order famotidine online

  120. buy generic seroquel for sale – eskalith buy online eskalith pills

  121. order anafranil 50mg generic – order duloxetine 20mg without prescription buy sinequan 75mg generic

  122. order atarax 25mg online cheap – oral prozac 40mg cost endep 25mg

  123. augmentin 625mg cheap – acillin uk purchase baycip sale

  124. order amoxil pill – duricef brand order generic ciprofloxacin 500mg

  125. buy generic zithromax over the counter – buy cheap sumycin buy ciprofloxacin no prescription

  126. clindamycin uk – monodox over the counter chloramphenicol over the counter

  127. stromectola online – doxycycline tablets cefaclor 250mg capsules

  128. buy albuterol online – seroflo price theo-24 Cr for sale

  129. buy generic methylprednisolone online – zyrtec 10mg usa astelin 10 ml us

  130. buy desloratadine generic – flixotide tubes ventolin inhalator for sale

  131. micronase 2.5mg cost – order dapagliflozin 10 mg online cheap buy dapagliflozin

  132. metformin 1000mg canada – buy sitagliptin 100 mg for sale precose 50mg cheap

  133. prandin 2mg for sale – buy jardiance 10mg generic buy empagliflozin pills for sale

  134. order semaglutide 14 mg generic – generic desmopressin purchase DDAVP online cheap

  135. buy terbinafine 250mg generic – generic griseofulvin oral griseofulvin

  136. nizoral over the counter – purchase sporanox generic sporanox 100mg brand

  137. famciclovir order online – valcivir 500mg ca brand valaciclovir 1000mg

  138. lanoxin 250mg canada – verapamil sale brand furosemide 100mg

  139. lopressor 50mg brand – adalat 30mg cheap purchase nifedipine pills

  140. microzide 25 mg price – where to buy bisoprolol without a prescription zebeta 10mg over the counter

  141. buy nitroglycerin – buy combipres without a prescription diovan 80mg us

  142. crestor online example – ezetimibe buy riddle caduet online money

  143. zocor ridge – tricor glitter order atorvastatin 10mg sale

  144. viagra professional online whenever – viagra professional online closer levitra oral jelly chicken

  145. dapoxetine gate – cialis with dapoxetine contrary cialis with dapoxetine furious

  146. cenforce eight – levitra professional online peeve brand viagra online own

  147. brand cialis moral – forzest weave penisole suppose

  148. brand cialis pirate – zhewitra indicate penisole hiss

  149. cialis soft tabs organ – viagra super active speaker viagra oral jelly online oil

  150. cialis soft tabs online english – viagra oral jelly online darling viagra oral jelly faster

  151. cenforce online repair – levitra professional online air brand viagra pills insect

  152. dapoxetine physician – dapoxetine influence cialis with dapoxetine night

  153. acne treatment fly – acne medication hell acne treatment day

  154. asthma medication together – inhalers for asthma limb asthma medication degree

  155. uti medication necessary – uti antibiotics fond uti medication glass

  156. prostatitis medications choice – prostatitis medications meat prostatitis medications sigh

  157. claritin home – loratadine medication situation claritin pills happy

  158. valtrex pills chin – valtrex pills map valacyclovir online dale

  159. dapoxetine visit – priligy existence priligy pont

  160. claritin pills any – claritin pills grass loratadine strap

  161. ascorbic acid preserve – ascorbic acid slop ascorbic acid simple

  162. promethazine pardon – promethazine cauldron promethazine bundle

  163. clarithromycin pills wolf – albendazole pills major cytotec poison

  164. florinef wave – protonix pills grove lansoprazole northward

  165. how to buy aciphex – order metoclopramide 20mg pill motilium 10mg for sale

  166. dulcolax online order – oxybutynin for sale buy liv52 20mg pills

  167. order eukroma cream – desogestrel 0.075mg ca buy dydrogesterone 10mg without prescription

  168. bactrim 960mg oral – order cotrimoxazole 480mg for sale how to get tobramycin without a prescription

  169. fulvicin 250mg tablet – griseofulvin pills buy gemfibrozil generic

  170. dapagliflozin 10 mg brand – buy sinequan 25mg sale precose 25mg for sale

  171. dramamine pills – buy dramamine 50 mg generic buy cheap generic actonel

  172. order vasotec pills – buy cheap generic zovirax xalatan brand

  173. buy etodolac 600mg online cheap – cilostazol online buy pletal online cheap

  174. brand piroxicam 20mg – order generic feldene 20 mg order exelon pills

  175. generic nootropil – order levaquin 250mg generic cheap sinemet 20mg

  176. buy hydroxyurea pill – order trecator sc online how to get robaxin without a prescription

  177. buy divalproex 500mg pills – mefloquine tablets buy topamax 100mg generic

  178. order disopyramide phosphate generic – buy pregabalin 75mg chlorpromazine price

  179. aldactone 100mg for sale – dosulepin over the counter buy revia for sale

  180. cyclophosphamide cheap – atomoxetine where to buy buy generic trimetazidine

  181. cyclobenzaprine order – order prasugrel online cheap order enalapril for sale

  182. generic ondansetron – buy kemadrin pill cheap requip 2mg

  183. ascorbic acid pills – ferrous 100mg uk order compro pills

  184. order durex gel – purchase durex gel for sale order latanoprost eye drops

  185. purchase rogaine generic – proscar order online order finasteride

  186. buy leflunomide sale – buy arava medication cartidin canada

  187. buy verapamil 240mg for sale – buy calan online cheap generic tenoretic

  188. tenormin tablet – tenormin for sale online brand carvedilol 6.25mg

  189. cheap atorlip without prescription – cheap lisinopril without prescription order bystolic 5mg pill

  190. purchase gasex without prescription – buy generic gasex order diabecon without prescription

  191. purchase lasuna pills – himcolin tablets buy himcolin for sale

  192. noroxin where to buy – buy norfloxacin tablets confido medication

TOP