11.1.2.1  Rules for Export Templates with E2B Industry Standards

The following rules apply when filtering E2B Export templates:  

·        Queries for all E2B Standard domains except AEDETS  and DRRE domains must be filtered by [PATIENTID] = ‘@@TrlObjectPatientId@’. This is automatically done. The PATIENTID filters are automatically inserted into the SQL code for every MAINSDTM record. The PATIENTID filters that are automatically generated are not visible in TrialBuilder.

·        Query for AEDETS domain must be filtered to return all Serious Adverse Events (SAEs).

·        In the RE domain, SRSDTH, SRSLIFE, SRSHOSP, SRSDISAB, SRSCONG and SRNIE variables must be mapped to an expression which could return either 0 or 1. [REDTDTC] from the RE domain must be mapped to the same expression as [STDATE] from AEDETS domain. If [STTIME] from AEDETS domain is mapped to a nonempty value, then the mapping expression for [REDTDTC] must include the same time value mapping. The resulting expression must be a valid date or date/time string (e.g. 2014/03/02 15:10).

·        [REENDTC] from the RE domain can have the time field concatenated with the date field if the time field is not null or empty. (e.g. 2014/03/02 15:10)

·        [REVRB] from the RE domain must be mapped to the same expression as [RETRANS] from AEDETS.

·        In the RE domain, REDTDTC and REENDTC variables must have the time field concatenated with the date field if the time field is not null or empty (e.g.,. 2014/03/02 15:10).

·        DRRE must not have any mapping.

·        The variable DTRT should be mapped to the same item in DR, DRAS, DRDO, DRIND and DRINFO domains.

·        If all variables of a domain are mapped to an empty string, all non-string mapped variables must return valid values that can be converted to the destination type (e.g. Date and Boolean) or mapped to “null”. (Don’t use the “Convert to E2B date/time” function.)

·        All non-string mapped variables must return valid values that can be converted to the destination type (e.g. Date and Boolean) or mapped to “null”. (Don’t use “Convert to E2B date/time” function.)

·        Two new SAE string variables can be used in E2B domains mappings and filtering. If there are multiple SAEs assigned to the same case, the variables contain the main SAE values (as displayed in the SAE Review report):

@@TermSae@ - Case term

@@DateStartSae - Case start date/time

Other new variables for E2B domains mappings and filtering:

@@CaseIdSae@ - Safety Report ID as specified in E2B_Cases table (column "CaseId")

@@DateCreateSae@ - time stamp when the Case is created as specified in E2B_Cases table (column "CreateDate")

@@DateRefreshSae@ - time stamp when the last refresh data request is executed

Note: During the data synchronization, the variables are replaced with the string values in SQL queries. The dates are replaced with the string formatted date as used in TM database (e.g. 'YYYY/MM/DD hh:mm:ss'). When used in expressions, the variables must be enclosed with single quotes.