1. A subject is assumed to violate Inc/Exc Criteria if sas$elig$crtno, sas$elig$crtty are not missing and sas$elig$encexok is N. A subject is assumed not to violate Inc/Exc Criteria if sas$elig$crtno, sas$elig$crtty are missing and sas$elig$encexok is Y. (These assumptions are made to handle possible mistakes in sas$elig)
  2. Baseline PSA/FPSA is the latest PSA/FPSA value prior to randomization - PSA/FPSA with sas$psa$sess < 3
  3. For a given subject and a given session number in the dateset sas$psa PSA record and FPSA record have the same date (sas$psa$vsdt value)
  4. If a subject has only one PSA/FPSA record and the date of PSA/FPSA is NA then PSA/FPSA is assumed to be NA (relevant for the dataset sas$psa)
  5. Prostate cancer family history is described in two datasets dishist (var dis) and status (var pcnr). A subject is assumed to have a prostate cancer family history if the subject has a prostate cancer family history according to at least one of the datasets
  6. If a subject has more than one record in any dataset (dishist or status) this subject is assumed to have family history of prostate cancer if at least one of the records says so
  7. A record in RAMOS is assumed to be invalid if it has both withdrawal.from.run.in and randomization (NOT (but should be) implemented in withdrawalReport() - waiting for Matt's opinion)
  8. A record in RAND (SAS) is assumed to be invalid if it both sbran 'Yes' and =nranrn is not missing (implemented in withdrawalReport())
  9. A subject is assumed to be randomized (according to RAMOS) if both values randomization and randomization.number are not missing (implemented in withdrawalReport())
Topic revision: r1 - 03 May 2005, SvetlanaEden
 

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