tblCEP - Clinical Events and Procedures


holds type and date of clinical events and procedures including serious non-AIDS conditions. Former known as tblAE (adverse event).

Core Fields

Note: Fields marked bold form the unique identifier for a record of the table.
Field name
Format
Description
numeric
Unique Event Identifier (foreign key to the different event tables)
character (or numeric if possible)
Code to identify patient (Cohort Patient ID)
yyyy-mm-dd
date of event
character. see coding table for valid codings.
identifies type of event
character. see coding table for valid codings.
further specification
numeric. See coding table for interpretation.
Depending on CEP_ID and CEP_SPEC: value of given event

numeric:

  • 1 = Yes
  • 0 = No
whether the source documentation is available
yyyy-mm-dd
date for source documentation verification

numeric:

  • 1 = Yes
  • 0 = No
Has the monitor verified the source documentation?
yyyy-mm-dd
date for monitor verification

numeric:

  • 1 = Yes
  • 0 = No
final verification/approval
yyyy-mm-dd
final verification date
character
signature for final verification

Additional Fields

Field name
Format
Description

numeric:

  • 1 = Yes
  • 0 = No
  • 9 = Unknown
has the patient had an event?
character
full name of the event
character
full description of the event

numeric:

  • 0 = not related
  • 1 = definitive
  • 2 = remote/unlikely
  • 3 = possible
  • 4 = probable
relation to treatment

QA Checks


TableCrosstableError CodeDescriptionStudy specificHICDEP?
AllTablesCrossTableATC001any date in database after DEATH_D in tblLTFU Yes
AllTablesCrossTableATC002any date in database after DROP_D in tblLTFU Yes
AllTablesCrossTableATC003any date in database before BIRTH_D in tblBAS Yes
AllTablesCrossTableATC004any date in database in the future Yes
AllTablesCrossTableATC005patients submitted previously who have been missed out Yes
AllTablesCrossTableATC006Any fields not coded as coding lists on table definition Yes