SD1028 - Inconsistent value for ELEMENT within TESTRL, TEENRL and TEDUR ??

b Bedeoan

on February 26, 2013

Hi all,

This rule states that:

Inconsistent value for ELEMENT within TESTRL, TEENRL and TEDUR Description of Element (ELEMENT) must have a unique value for a given combination of Rule for Start of Element (TESTRL), Rule for End of Element (TEENRL), and Planned Duration of Element (TEDUR) within the domain

But if we check "SENDIGv3.pdf" Chapter 7.2 Trial Elements page 180 we get examples where the combination of TESTRL+TEENRL+TEDUR is the same for multiple ELEMENT values.

See the attached te.txt file for which this error is reported.

STUDYID    DOMAIN    ETCD    ELEMENT    TESTRL    TEENRL    TEDUR
ST_name    TE    G1/F    0 mg/kg Aga aga, 1/day of 5 mL/kg F    Day 0    Day 24    P24D
ST_name    TE    G1/M    0 mg/kg Aga aga, 1/day of 5 mL/kg M    Day 0    Day 24    P24D
ST_name    TE    G2/F    10 mg/kg Aga aga, 1/day of 5 mL/kg F    Day 0    Day 24    P24D
ST_name    TE    G2/M    10 mg/kg Aga aga, 1/day of 5 mL/kg M    Day 0    Day 24    P24D
ST_name    TE    G3/F    250 mg/kg Aga aga, 1/day of 5 mL/kg F    Day 0    Day 24    P24D
ST_name    TE    G3/M    250 mg/kg Aga aga, 1/day of 5 mL/kg M    Day 0    Day 24    P24D
ST_name    TE    G4/F    1000 mg/kg Aga aga, 1/day of 5 mL/kg F    Day 0    Day 24    P24D
ST_name    TE    G4/M    1000 mg/kg Aga aga, 1/day of 5 mL/kg M    Day 0    Day 24    P24D

Forums: Validation Rule Suggestions

s Sergiy

on February 27, 2013

Hi Amelia, You are correct.

Hi Amelia,

You are correct. I do not remember details, but this SD1028 check was actually removed from all configurations after v1.3 release. It is not present in a new v1.4 version.

Thanks,

Sergiy