Difference between revisions of "SDTM Validation Minutes 2013"

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(Created page with "__TOC__ == Working Group Leadership == {| class="wikitable" |- ! Role !! Names |- | Project Leads|| Mike Molter, Majdoub Haloui |- | Industry|| Max Kanevsky, Hany Aboutaleb |- |...")
 
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<br>Facilitator:  Mike Molter, Majdoub Haloui
 
<br>Facilitator:  Mike Molter, Majdoub Haloui
  
==Agenda==
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===Agenda===
 
# Revisit OpenCDISC previous Action Items
 
# Revisit OpenCDISC previous Action Items
 
# Continue reviewing rules
 
# Continue reviewing rules

Revision as of 10:36, 14 May 2013

Working Group Leadership

Role Names
Project Leads Mike Molter, Majdoub Haloui
Industry Max Kanevsky, Hany Aboutaleb
FDA DJ Chhatre, Doug Warfield
Steering Committee Liaison Anne Russotto
Project Manager Lisa Lyons

May 6, 2013


When: 02:00pm-3:00pm (EST) , Bi-weekly Mondays
Place: Teleconference
Facilitator: Mike Molter, Majdoub Haloui

Agenda

  1. Revisit OpenCDISC previous Action Items
  2. Continue reviewing rules

General discussion

Reviewed following ID #s from the SDTM Validation Rule Spreadsheet. Note: Revisited items ID1, ID2 since we had OpenCDISC representation.

  • ID1: Wasted space/padded variables
  • ID2: Dataset size
  • ID3: Duplicate USUBJID/DECOD/--STDTC
  • ID5: Rule # SD0006 No baseline result in [Domain] for subject
  • Following rules were discussed together due to similar issue;
  • ID7: Rule # SD0029 Missing value for --STRESU, when --STRESC is provided
  • ID8: Rule # SD0031 Missing values for --STDTC and --STRF, when --ENDTC or --ENRF is provided
  • ID10: Rule # SD0035 Missing value for --DOSU, when --DOSE, --DOSTXT or --DOSTOT is provided
  • ID11: Rule # SD0046 All values of Qualifier Variable Label (QLABEL) should be the same for a given value of Qualifier Variable Name (QNAM)
  • ID12: Rule # SD0063 SDTM/dataset variable label mismatch


Action Items

Following ID's discussed at the meeting (ID1, ID2, ID3, ID5, ID7, ID8, ID10, ID12) need to be revisited with OpenCDISC/FDA at next meeting

ID11: Mike/Majdoub follow-up with Ann Russotto to see who she sent ID11 to at SDS and see if any progress has been made on clarifying IG.

April 22, 2013


When: 02:00pm-3:00pm (EST) , Bi-Weekly Monday
Place: Teleconference
Facilitator: Mike Molter, Majdoub Haloui

Agenda

  1. Introductions
  2. Review action items discussed at March conference and follow up on status

General discussion

Introductions:

  • Introduced new co-leads and provided overview of how future meetings will be run
  • Meeting invitee quick introduction

Review of Conference Action items

  • Reviewed following ID #s from the SDTM Validation Rule Spreadsheet
  • ID1: Wasted space/padded variables
  • ID2: Dataset size
  • ID4: Rule ID # SD0002 (NULL Values in variables marked as required)
  • ID6: Rule ID# SD0026 (Missing value for --ORRESU, when --ORRES is provided)

Action Items

  • ID1:
  • FDA to update CDER Common Data Standards Issues and Study Data Specifications to reflect final decision regarding no padding of data.
  • OpenCDISC needs to update check based on decision regarding no padding of data
  • ID2:
  • FDA needs to harmonize wording between CDER Common Data Standards Issues and Study Data Specifications on how to handle split datasets.
  • Majdoub needs to update the SDTM Validation Rule spreadsheet to not give impression sponsors should be applying the resize macro avail from FDA. Change needs to be "sponsors should resize the data first".
  • ID4:
  • FDA needs to provide specific examples because it was not clear to the group.
  • ID6:
  • FDA will generate a list of variables that have the issue and we will discuss it with the group to determine how to resolve the issue.

Follow up


Last revision by DanBoisvert,05/14/2013