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PMDA Valida+on Rules Preparing for your next submission to Japanese Pharmaceu6cals and Medical Devices Agency Max Kanevsky December 10, 2015

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Page 1: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

PMDA  Valida+on  Rules  Preparing  for  your  next  submission  to  Japanese  Pharmaceu6cals  and  Medical  Devices  Agency        Max  Kanevsky  December  10,  2015    

Page 2: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Presenter  –  Max  Kanevsky    ›  Founder  of  OpenCDISC  ›  CEO  of  Pinnacle  21  ›  Valida6on  tool  implementer    at  PMDA  and  FDA  

›  SME  on  FDA  JumpStart  Service  

Page 3: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Disclaimer  The  views  and  opinions  presented  here  represent  those  of  the  speaker  and  should  not  be  considered  to  represent  advice  or  guidance  on  behalf  of  the  Pharmaceu6cals  and  Medical  Devices  Agency  and  Food  and  Drug  Administra6on.      

Page 4: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Topics  ›  Rebranding  and  new  releases  ›  PMDA  guidance  and  valida6on  rules      ›  Rule  structure  and  content  ›  Comparison  between  PMDA  and  FDA  ›  Using  Pinnacle  21  tools  to  prepare  for    PMDA  submission  ›  Recommenda6ons  

Page 5: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

ENTERPRISE COMMUNITY

OpenCDISC  has  rebranded  

›  Why  ›  Requested  by  CDISC  

›  When  ›  Effec6ve  November  9th  

›  What  does  it  mean  to  you  ›  No  changes  in  func6onality  or  business  model  ›  The  only  thing  that  changes  is  the  name  ›  OpenCDISC.org  content  will  be  migrated  under  Pinnacle21.net  by  spring  2016  

Page 6: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Pinnacle  21  Releases    

›  Community  2.1.0  ›  Released  December  7th  ›  Open  source  desktop  toolkit  for  programmers  to    

QC  their  standardized  deliverables  

›  Enterprise  3.0.0  ›  Released  November  2nd  ›  SaaS  collabora6ve  environment  for  regulatory  

submission  prep,  standards  management,  and  con6nuous  compliance  

›  Used  by  PMDA  and  FDA  to  validate  incoming  submissions    

with  PMDA  valida+on  rules  support    

Page 7: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

 

PMDA  Guidance  

Page 8: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

“PMDA  will  perform  the  valida5on  of  all  submi:ed  electronic  data.  Valida5on  of  conformance  to  the  CDISC  standard  will  be  performed  using  a  tool  known  as  the  OpenCDISC  Enterprise.”    

“The  applicant  should  confirm  in  advance  the  conformity  degree  of  the  data  to  the  CDISC  standards  prior  to  the  applica5on  by  referring  to  the  published  rules  and  informa5on  on  the  PMDA  valida5on  environment.”    

“In  addi5on,  the  error  must  be  explained  in  the  data  guide  (SDRG  and  ADRG).”    *Source:  No6fica6on  on  Prac6cal  Opera6ons  of  Electronic  Study  Data  Submissions  

Valida+on  Requirement  

Page 9: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

The  first  release  of  PMDA  rules  ›  Published  November  24th  ›  Based  on  the  latest  Pinnacle  21  rules  ›  Changes  in  Severity,  Message  and  Descrip6on  ›  Introduces  addi6onal  PMDA  specific  valida6on  rules  

Page 10: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Covered  Standards  

›  SDTM  IG  3.2  ›  SDTM  IG  3.1.3  (3.1.2  Amendment  1)  ›  SDTM  IG  3.1.2  

›  ADaM  IG  1.0  

›  Define-­‐XML  2.0  ›  Define-­‐XML  1.0  

Page 11: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Rules  document  structure  ›  Excel  format  ›  “machine  readable”  › Most  commonly  used  for  metadata  ›  Easy  to  use  

›  Columns  ›  Rule  ID  (same  as  Pinnacle  21  Rule  ID)  › Message,  Descrip6on  ›  Domains,  PMDA  Severity  ›  Standards,  PMDA  Notes      

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Severity  ›  Reject  –  rules  which,  if  violated,  will  cause  the  review  to  be  suspended  un6l  correc6ons  have  been  made.  ›  Error  –  rules  which,  if  violated  without  any  prior  explana6on,  will  cause  the  review  to  be  suspended  un6l  correc6ons  have  been  made.  › Warning  –  rules  which,  even  when  violated,  will  not  necessarily  require  any  explana6on.  

Page 14: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Reject  Rules  

Standard   #  of  Reject  Rules  

SDTM   9  

ADaM   12  

Define-­‐XML   13  

Page 15: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Reject  Rules  (SDTM)  

Page 16: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Reject  Rules  (ADaM)  

Page 17: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Reject  Rules  (Define-­‐XML)  

Page 18: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Reject  Rules  (Excep+ons)  ›  Viola6on  of  CT2001  for  the  following  variable/codelist  pairs  will  be  considered  part  of  Rejec6on  criteria.  All  others  will  be  considered  Errors.  

Variable   Codelist  

AGEU   AGEU  

COUNTRY   COUNTRY  

IECAT   IECAT  

RELTYPE   RELTYPE  

SEX   SEX  

-­‐-­‐BLFL   NY  

-­‐-­‐DRVFL   NY  

-­‐-­‐FAST   NY  

Variable   Codelist  

-­‐-­‐OCCUR   NY  

-­‐-­‐PRESP   NY  

AESER   NY  

AESCONG   NY  

AESDISAB   NY  

AESDTH   NY  

AESHOSP   NY  

AESLIFE   NY  

Variable   Codelist  

AECONTR   NY  

AESCAN   NY  

AESMIE   NY  

AESOD   NY  

IEORRES   NY  

IESTRESC   NY  

-­‐-­‐STAT   ND  

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Reject  Rules  (Excep+ons)  ›  Viola6on  of  CT2004  for  the  following  variable/codelist  pairs  will  be  considered  part  of  Rejec6on  criteria.  All  others  will  be  considered  Errors.  

Variable   Codelist  

TSVAL  when  TSPARMCD  value  is  SEXPOP   SEXPOP  

TSVAL  when  TSPARMCD  value  is  ADDON   NY  

TSVAL  when  TSPARMCD  value  is  RANDOM   NY  

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Reject  Rules  (Excep+ons)  ›  Viola6on  of  SD0002  will  be  considered  part  of  Rejec6on  criteria,  except  for  the  following  variables  in  DM  domain  that  will  be  considered  

Variable  

ARMCD  

ARM  

ACTARMCD  

ACTARM  

Page 21: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

How  do  PMDA  valida+on  rules  differ  from  rules  published  by  FDA?  

Page 22: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

PMDA   FDA  

SDTM  3.2   ✔  

SDTM  3.1.3   ✔   ✔  

SDTM  3.1.2   ✔   ✔  

SDTM  3.1.1   ✔  

SEND  3.0   ✔  

ADaM  1.0   ✔  

Define.xml  2.0   ✔  

Define.xml  1.0   ✔  

Difference  1:    Covered  standards  

Page 23: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Difference  2:    

PMDA       FDA  326     314  

SDTM  rule  severity  

Page 24: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Difference  3:  SDTM  rule  severity  by  dimension  

FDA  PMDA  

FDA  PMDA   FDA  PMDA  

FDA  PMDA  

FDA  

PMDA  

Page 25: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Difference  4:  New  rules  

›  21  new  rules  › Mostly  to  check  data  quality  ›  Examples  ›  Observa6ons  aler  End  of  Par6cipa6on  ›  Treatments  before  the  First  Study  Treatment  or  aler  Last  Study  Treatment    

›  Incorrectly  set  AE  Serious  Event  flag  ›  Nega6ve  Study  Day  in  Exposure  

Page 26: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Difference  5:  Removed  rules  

›  9  rules  removed  ›  All  deal  with  Trial  Summary  parameters  controlled  by  FDA  Substance  Registra6on  System  (SRS)  ›  PMDA  doesn’t  use  FDA  SRS  dic6onary  

Page 27: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Difference  6:  Redefined  rules  

FDA  Rule   PMDA  Rule   Change  

SD1071:  Dataset  is  greater  than  1  GB  in  size  

SD1142:  Dataset  is  greater  than  5  GB  in  size  

PMDA  can  support  larger  datasets  of  5  GB  

SD1077:  FDA  Expected  variable  not  found  

SD1140:  PMDA  Expected  variable  not  found  

FDA  expects  ELEMENT  and  EPOCH,  while  PMDA  expects  -­‐-­‐BLFL  and  EPOCH  

SD1097:  No  Treatment  Emergent  info  for  Adverse  Event  

SD1141:  No  Treatment  Emergent  info  for  Adverse  Event  

Change  in  Descrip6on    

SD0008:  Value  for  -­‐-­‐DECOD  not  found  in  MedDRA  dic6onary  

Same   PMDA  limits  this  check  to  AE  domain  only  

SD0008C:  Value  for  -­‐-­‐DECOD  is  in  incorrect  case  

Same   PMDA  limits  this  check  to  AE  domain  only  

Page 28: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Differences  Conclusion  ›  Except  for  severity,  rules  are  consistent  

across  FDA  and  PMDA  ›  Even  though  PMDA  has  Reject  criteria,    

FDA  rules  are  s6ll  far  more  strict  ›  FDA  has  more  experience  and  more    

tools/analysis  that  depend  on  standard  data  ›  It’s  PMDA’s  first  version,  requirements  are  expected  to  

increase  over  6me  ›  77%*  of  all  submission  to  FDA  in  2014-­‐15  failed  to  load  to  

Clinical  Trial  Repository  (CTR),  so  don’t  be  surprise  to  see  Reject  criteria  from  FDA  too  

 *  Common  Errors  in  Loading  SDTM  Data  to  the  Clinical  Trial  Repository,  Crystal  Allard,  FDA  OCS  

Page 29: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

How  to  use  Pinnacle  21  tools  to  prepare  for  PMDA  submission?  

Page 30: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Recommenda+ons  ›  Always  use  the  latest  available  valida6on  rules  and  latest  version  of  Pinnacle  21  tools  

›  Comply  with  highest  severity  across  agencies  ›  You’ll  likely  need  to  submit  to  both  ›  Requirements  will  only  get  more  strict  

›  Fix  all  issues  that  are  fixable  and  explain  the  rest  ›  Follow  “Con6nuous  Compliance”  approach,    catch  and  fix  data  issues  as  early  as  possible  

Page 31: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Resources  ›  PMDA  Guidance  and  informa6on  webpage                  hqp://www.pmda.go.jp/english/review-­‐services/reviews/advanced-­‐efforts/0002.html  

›  Basic  Principles  on  Electronic  Submission  of  Study  Data  for  New  Drug  Applica6ons  

               hqp://www.pmda.go.jp/files/000153708.pdf  

›  No6fica6on  on  Prac6cal  Opera6ons  of  Electronic  Study  Data  Submissions  

         hqp://www.pmda.go.jp/files/000206451.pdf  ›  Technical  Conformance  Guide  on  Electronic  Study  Data  

Submissions                    hqp://www.pmda.go.jp/files/000206449.pdf  

›  Data  Standard  Catalog                  hqp://www.pmda.go.jp/files/000206482.zip  

›  Study  Data  Valida6on  Rules    hqp://www.pmda.go.jp/files/000208341.zip  

Page 32: PMDAValida+on%Rules% - Pinnacle 21 · 2016-05-05 · PMDAValida+on%Rules% Preparing)for)your)nextsubmission)to)Japanese) Pharmaceu6cals)and)Medical)Devices)Agency)))) Max)Kanevsky)

Get  updates  about  our  events  linkedin.com/company/pinnacle-­‐21  

twiqer.com/pinnacle_21  

facebook.com/pinnacle21  

pinnacle21.net/blog  

opencdisc.org  

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Ques+ons      Max  Kanevsky  [email protected]  


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Pinnacle Owners Manual 824 · 2016. 12. 13. · Pinnacle Pinnacle Appliances Pinnacle. Title: Pinnacle Owners Manual 824.cdr Author: Ninu Ninka Created Date: 12/13/2016 7:10:39 PM

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