SDTM

Hi

What is the difference between planned number of subjects and actual number of subjects in Trial Summary domain?

In one of the study I am working on, 30 subjects were planned as per protocol and all of them (30) were screened. Later on, one subject withdrew from study and did not receive the dosing. In such scenario, what should be the actual number of subjects, 29 or 30?

Thanks.

Regards,
Wick

I have a problem in the TS Domain SDTM datasets were integrated the two studies.

The following errors have occurred:

Non-unique value for TSSEQ variable within TSPARMCD
Multiple ADDON records
Multiple AGEMAX records
Multiple AGEMIN records
Multiple LENGTH records
Multiple PLANSUB records
Multiple RANDOM records
Multiple SEXPOP records
Multiple NARMS records

I think it is not validation by STUDYID. Why do I get these errors when STUDYID is different?

Hi,

Few mathematical symbols like >= and unit values like uL(microliter) are present in value of IETEST in TI domain. Pinnacle(v 3.2) does not throw an error for non-ascii and non-printable chars for TI domain, but in the IE it seems that there is a validation rule to check IETEST values and it threw an error FDAC241 in IE stating non-ascii or non-printable chars are present in the text. 

Is it something that tool does not check for non-ascii or non-printable char in TI domain(or entire Trial Design)? 

Thanks,

Abdul.

Hello,

I have to export study data in .xpt version 5 format (for submission to FDA). I develop it in C#.

So far so good, I have troubles understanding the remaining validation errors: Non-unique value for TAETORD within ARMCD

Please can someone help me understanding the correct format for TAETORD variable? It it described in SDTM 1.5 as a numeric value.

[EDIT] I think I have to convert the integer to the IBM mainframe number format, this gives me a byte[8], then I have to properly encode this. I'm testing encoding each of the 8 byte values to ascii chars.

Hi,

We try to make the report as clean as possible, but it seems we can't implement this. It seems there are some rules that conflict with each other, either way, there will be a warning in the report. For example, for the following 2 rules, if we add EPOCH, we will violate the 1st rule; if we remove EPOCH, we will violate the 2nd rule. Can you suggest what should we do to get rid of the warning?

SD1076/FDAC031

Model permissible variable added into standard domain

We noticed that CO.COVALn and TS.TSVALn variable labels have the number appended. The IG gives advice in case 2 below that seems to conflict with this.

There are two scenarios where this topic arises:

I am wondering if findings related to Gynecological Examination, Vaginal Examination, Vaginal Cell Maturation Index, Endometrial Biopsy and PAP Smear should go into the Reproductive System Findings (RP) or the Physical Examination (PE) domain. SDTMIG 3.2 does mention that the RP domain should capture all Reproductive information related to a subject but I find that these types of findings do not directly relate to “birth” as most examples provided in the SDTMIG 3.2 do.

Hi, I'm somewhat confused about rule SD1202 that specifies that a --STDTC must be before of equal RFPENDTC. I have an example of a patient who was lost to follow-up for which the last contact date was recorded in both DM.RFPENDTC and DS.DSSTDTC as the last line in DS domain.

The end of study visit was completed afterwards with an end of study visit date greater than the last contact date of the patient.

The problem is that I get an issue that says that my end of study visit date (SV.SVSTDTC) is greater than DM.RFPENDTC.

Hi Team,

We have created a custom domain with the name "LBUS" (Domain= LBUS) which is similar to "LB" and it is not a split domain. But when Pinnacle 21 checks the two datasets, it thinks LBUS as the split dataset of LB. It issues duplicated LBSEQ error. 

Can you please explain me why is this happening? Thanks in advance.

Regards,

Sai Krishna.

FDAC032 recommends using identical data type but its different in P21 checks - any specific reason?

Venkata