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OpenCDISC Rules for Discussion. March 18-19, 2012. CDER’s Top Issues. Wasted Space Description: Currently, sponsors pad column widths by arbitrarily pre-allocation column widths to 200, loosely based on the previous IG example IG is updated, as is the FDA’s CID

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cder s top issues
CDER’s Top Issues
  • Wasted Space
  • Description:
    • Currently, sponsors pad column widths by arbitrarily pre-allocation column widths to 200, loosely based on the previous IG example
    • IG is updated, as is the FDA’s CID
    • Ideally, column widths should only be the maximum length used in that column across records
  • Solution:
    • Should we use extra characters used or %?
    • Exceptions?
cder s top issues1
CDER’s Top Issues
  • Dataset Sizes
  • Description:
    • Based on FDA’s SDS and CID
  • Solution:
    • Limit set to 1 gb
    • Warning acceptable for this?
    • Should warning/error be based on certain limits?
      • Warning 1 gb to 1.25 gb
      • Error > 1.5?
cder s top issues2
CDER’s Top Issues
  • Expected –DY variable when –DTC present
  • Description:
    • Are these three situations enough?
      • --DY variable value is not populated
      • --DY variable value is imputed
      • Incorrect value for --DY variable
  • Solution:
    • Someone brought up an issue with this
    • Extra rule check or edit of existing rule check?
    • Is warning appropriate?
cder s top issues3
CDER’s Top Issues
  • Duplicate USUBJID/--DECOD/--STDTC record
  • Description:
    • E.g. AEs with same start date
    • Situation for imputed dates?
  • Solution:
    • Add rule or modify to exclude any partial dates in records
    • Change to information if partial date?
cber s top open issues

CBER’s Top (open) Issues

Project Breakout Session

March 18-19, 2013

cber s top issues
CBER’s Top Issues
  • * SD0002: Required variable is null
  • Description:
    • This issue occurs across domains (LB, AE, TS, FA, etc.)
    • Why does this occur? EDC system issue? Quality Control?
    • If value not taken/recorded, how to avoid “null” entry? Screen failure? Explanation in Reviewer’s Guide?
    • Should check be adjusted if all/majority of values in a variable column are null/missing? Different check?
cber s top issues1
CBER’s Top Issues
  • * SD0006: No Baseline Result in [domain] for subject
  • Description:
    • While SDTM requires baseline, not all tests have a “baseline” value
    • Is this a CBER issue, or is it ubiquitous?
  • Proposal:
    • Should existing rule be split for different LBTESTCDs that do not have a baseline to avoid false positives?
    • Is this currently in progress?
cber s top issues2
CBER’s Top Issues
  • * SD0026/29/35: Standard unit null when standard result is provided
  • Description:
    • Implementation issue? EDC?
    • Or is the issue that not all LBTESTs have associated unit?
  • Proposal:
    • Identify rules with no units and update implementation
    • Define.xml or TS domain for list of tests w/o unit
    • Add additional variable to indicate LBTEST has no unit
    • Utilize screen failure if applicable?
cber s top issues3
CBER’s Top Issues
  • SD0031: Missing values for --STDTC and --STRF, when --ENDTC or --ENRF is provided
  • Description:
    • Data collection issue
    • Con meds for ongoing, so have ENRF but no start information
  • Proposal:
    • Adjust business rule on how to represent exposures that happen in a “moment in time”
    • CT for situations where started before trial but now ongoing
    • STRTPT could be used to represent event/intervention occurred prior, but would need to amend IG for clarification
cber s top issues4
CBER’s Top Issues
  • SD0063: SDTM/Dataset variable label mismatch
  • Description:
    • Variable label should match label described in SDTM
    • When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted
    • There was an issue in OpenCDISC v.1.3 that was resolved -> false positive resolved? Does anyone else see this issue now?
    • When would this issue arise at your company?
cber s top issues5
CBER’s Top Issues
  • SD0070: No EX record for subject
  • Description:
    • Typical for follow-on studies where exposure occurred in first study so no exposure in “this” study
    • Randomized but not “treated” -> perhaps subject died
    • Phase 0 study looking at population but no treatment being provided
  • Solution:
    • ACTARMCD provided in 3.1.3 which allows NOTTRT
    • OpenCDISC can check this to increase accuracy of rule validation
    • Important review piece for FDA reviewers
cber s top issues6
CBER’s Top Issues
  • SD0087/88: RFSTDTC/RFENDTC is not provided for a randomized subject
  • Description:
    • Why does this issue occur?
    • What do you all use this information to relay?
    • Data not collected? Study Design? EDC?
      • If not collected, is screen failure viable option with explanation in reviewer’s guide?
  • Proposal:
    • Smart checks based on study design? Is this possible to even implement?
cber s top issues7
CBER’s Top Issues
  • * CTxxxx: Many Codelist Issues
  • Description:
    • Invalid codelist value not found in codelist
    • This is not necessarily an extensible codelist vs. SDTM codelist issue
  • Proposal:
    • When using extensible codelists, reference needs to be made in define.xml
    • This will eliminate “most” CT issues in your OpenCDISC report which arose due to faulty define.xml
    • Update define.xml code specifying external code list dictionary
cder s top issues4

CDER’s Top Issues

Project Breakout Session

March 18-19, 2013

cder s top issues5
CDER’s Top Issues
  • File System Checks
  • Description:
    • Although OpenCDISC v1.4 checks CID for checks, what about other relevant documents, such as the Study Data Specifications?
    • Folder structure is one avenue to consider as FDA automates processes that require these items
    • Define.xml is another
  • Solution:
    • Create new checks? Is this business rule specific?
cder s top issues6
CDER’s Top Issues
  • SD0003/1011: ISO Dates
  • Description:
    • ISO date field used as duration spec, not just start/stop (i.e. AE)
    • Partial dates are difficult to interpret/analyze
    • If duration field is inputted in expected start/stop, is this detected?
  • Solution:
    • Create new checks? Is this business rule specific?
cder s top issues7
CDER’s Top Issues
  • Traceability
  • Description:
    • Being able to trace data between CRFs/SDTM/ADaM
    • FDA reviewers want this, but how do you provide?
    • Very, very difficult to solve this issue
  • Solution:
    • ?
cder s top issues8
CDER’s Top Issues
  • SD0064: Invalid subject
  • Description:
    • Subject in non-DM domain but no record in DM
    • Recorded information but subject did not receive treatment? Withdrew prematurely?
  • Solution:
    • Does ACTARMCD provide solution?
    • Use screen failure and add information to ACTARMCD?
cder s top issues9
CDER’s Top Issues
  • SD0038: Study Day value = 0
  • Description:
    • IG is clear that Study Day can be -1 or 1, but not 0
    • Understanding or implementation issue?
  • Solution:
    • Discuss OpenCDISC v1.4’s new checks for this
cder s top issues10
CDER’s Top Issues
  • SD0080: AE start date is after the latest Disposition date
  • Description:
    • Sometimes, this last disposition date not recorded
    • Other times, protocol requires follow-up period for AEs while the disposition date is listed in original trial schedule
  • Solution:
    • Modify checks?
cder s top issues11
CDER’s Top Issues
  • SD1005: Invalid StudyID
  • Description:
    • StudyID values don’t match StudyID in DM
    • This seems like a simple issue to resolve -> why does this happen?
    • This metadata checking is important to FDA processes
    • Issues can include: dashes, added date, abbreviated study names, etc…
  • Proposal:
    • Add additional checks for other StudyID locations (define.xml, index.xml, stf.xml?) for additional accuracy
cder s top issues12
CDER’s Top Issues
  • SD0065: Invalid subject visit/visit number
  • Description:
    • All Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combination values in data should be present in the Subject Visits (SV) domain
    • Is this a data quality check issue?
cder s top issues13
CDER’s Top Issues
  • SD0040: Inconsistent value for --TEST within --TESTCD
  • Description:
    • All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD)
    • 1:1 relationship between test code and name
    • Why would this be different?
cder s top issues14
CDER’s Top Issues
  • SD0005: Duplicate --seq
  • Description:
    • The value of Sequence Number (--SEQ) variable must be unique for each record within a subject
    • Why would this occur?
    • Is this because a subject comes in twice for a single sequence because no data reported in first sequence?
cder s top issues15
CDER’s Top Issues
  • SD0004: Inconsistent value for DOMAIN
  • Description:
    • Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset
    • Why would this ever break?
    • Due to split domains?
cder s top issues16
CDER’s Top Issues
  • SD0007: Inconsistent value for Standard Units
  • Description:
    • Standard Units (--STRESU) must be consistent for all records with same Short Name of Measurement, Test or Examination (--TESTCD) and Category (--CAT)
    • Same test in different category is considered, so why does this rule still break?
cder s top issues17
CDER’s Top Issues
  • SD0018: Invalid value for --TESTCD variable
  • Description:
    • The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores
    • Clear and concise explanation -> why does this rule still break so often?
cder s top issues18
CDER’s Top Issues
  • SD0048: Value for --ORRES is populated, when --STAT is 'NOT DONE'
  • Description:
    • Status (--STAT) should be NULL, when Result or Finding in Original Units (--ORRES) is provided
    • Seems simple to resolve -> why does this rule break?Other points to consider? Special cases?
cder s top issues19
CDER’s Top Issues
  • SD0077: Invalid referenced record
  • Description:
    • Reference record defined by Related Domain Abbreviation (RDOMAIN), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR) and Identifying Variable Value (IDVARVAL) must exist in the target Domain
    • Does data belong in parent domain and not suppqual?
    • This can (and does) happen -> data dumped into suppqualbecause not sure where else to put it
    • If no clear parent, should it be included?
    • Custom domain?
cder s top issues20
CDER’s Top Issues
  • SD0061: Domain referenced in define.xml but dataset is missing
  • Description:
    • Domains referenced in data definition document (define.xml) should be included in the submission
    • Seems simple enoughto implement
    • Poor define.xml management or other reason?
    • Can compare define metadata with SDTM data library
cder s top issues21
CDER’s Top Issues
  • SD0017(others): Variable lengths
  • Description:
    • The value of xxxx should be no more than yy characters in length
      • --TEST, --TESTCD, TSPARM, ARMCD,
    • Are there extenuating circumstances to these rules where character limits may not be enough?
      • Adjust OpenCDISC checks to accommodate?
    • What’s the difference between SD0017 and SD1058? Duplicate rules?
cder s top issues22
CDER’s Top Issues
  • New check ideas
    • Check for domains with no records
      • Why did sponsor submit this domain for ‘review’?
    • No define.xml present (although define.pdf exists)
      • Warning for now until included in some documentation or IG
      • Allows for maximum use of standardized data
cab vp opencdisc reconciliation open issues

CAB/VP OpenCDISC Reconciliation – Open Issues

Project Breakout Session

March 18-19, 2013

cab vp opencdisc
CAB/VP OpenCDISC
  • SD0031
  • Description:
    • Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL, when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL
  • Proposed Solution/Action:
    • Requires additional discussion originally sent to CBER Top 20 Validation Rule Failures project team for further discussion.
cab vp opencdisc1
CAB/VP OpenCDISC
  • SD0046
  • Description:
    • All values of Qualifier Variable Label (QLABEL) should be the same for a given value of Qualifier Variable Name (QNAM)
  • Proposed Solution/Action:
    • Send to the SDS Team to clarify what the IG should say regarding the uniqueness of these one-to one relationships.
cab vp opencdisc2
CAB/VP OpenCDISC
  • SD0081
  • Description:
    • Date/Time of Collection (--DTC) should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC)
  • Proposed Solution/Action:
    • Requires additional discussion originally sent to CBER Top 20 Validation Rule Failures project team for further discussion.
cab vp opencdisc3
CAB/VP OpenCDISC
  • SD0093
  • Description:
    • 'Age Units (AGEU) should be provided, when Age (AGE) is populated
  • Proposed Solution/Action:
    • Send to Change Control Board to be changed to an error.
cab vp opencdisc4
CAB/VP OpenCDISC
  • New Rules for Consideration
    • RelationshipType (RELTYPE) populated as 'ONE' must not have more than one record present in the RDOMAIN with the corresponding IDVAR.
    • A DATE/TIME OF COLLECTION is available, but the STUDY DAY OF VISIT/COLLECTION/EXAM is missing.
    • If both start date of observation and reference date are populated with complete dates, then --STDY should be populated.
cab vp opencdisc5
CAB/VP OpenCDISC
  • New Rules for Consideration
    • If both end date of observation and reference date are populated with complete dates, then --ENDY should be populated.
    • Study Day variable(--DY) is not null but the variables required for the calculation (DM.RFSTDTC and --DTC) are not complete. 2. Study Day variable(--STDY) is not null but the variables required for the calculation (DM.RFSTDTC and --STDTC) are not complete. 3. Study Day variable(--ENDY) is not null but the variables required for the calculation (DM.RFSTDTC and --ENDTC) are not complete.