AD0366A Missing value for RANDDT, when RANDFL is Y not in Enterprise Version ?

Pinnacle 21 Support ADaM
1

Hi Angela,

My assumption is that you refer to validation of ADaM IG 1.0.

P21E 3.4.4 is outdated version released in 2018. Please always use the most recent versions of software.

SD0366A rule was introduced in P21E 3.4.2 only for ADaM IG 1.1.

Later in P21E 4.0 (April, 2019) and P21C 3.0 (May, 2019), this rule was also applied to ADaM IG 1.0.

Kind Regards,

Sergiy

2

Many thanks for this quick answer.

The validation was for ADaM IG 1.1 as stated in the ADRG and the Validation report. Therefore, I would have expected this error to show up.

Best regards,

Angela

3

Hi Angela,

As I understand, your case is

  1. RANDFL variable is present and some records have RANDFL=‘Y’
  2. RANDDT variable is not present in ADSL dataset

Then you should expect validation message 'AD0366: Missing RANDDT variable, when RANDFL variable is present’

AD0366A rule ‘Missing value for RANDDT, when RANDFL is Y’ is not applicable here due to missing RANDDT variable.

Validation results from your vendor are correct. Issue AD0366A should not be reported in both versions of the Validator you refer to.

Kind Regards,

Sergiy

4

Dear all,

in a FDA submission relevant study we encountered the problem that the Vendor version (Enterprise 3.4.4) does not find the AD0366A Error (Missing value for RANDDT, when RANDFL is Y) whereas our Sponsor Community Version (the newest) state this as an error. I’d rather expect it the other way around.

Indeed, the RANDFL is available but not a RANDDT variable. The Vendor does not accept this ERROR as it does not pop up in the Enterprise Version.

Is there anything I oversee ?

Many thanks for looking into this.

Best regards,

Angela Remy (Biotest AG)