ADaM

Hi,

ADaM guideline only demostrates numeric Date/Time variable naming convention.  I wonder if character Date/Time variables are also accepted.  For example, TRTSDT verse TRTSDTC or TRTSDTM verse TRTSDTMC.

It's very easy to identify TEAE by comparing AESTDTC to TRTSDTC and follow-up date after last dose in character value while AESTDTC contains partical date information.  So that, imputation for missing date is not necessary.

Thanks.

Hui

Hi,

 

I was looking to find what checks are performed additionally when I provide a define file to OpenCDISC whenever I am validating the ADaM datasets with ADaM configuration. I did not find any answer (or I looked in all the wrong places).

Can anyone help me out on this one?

I have a general interest: all checks on define vs. data.
And I have a particular interest: Is CT -as provided in the define - checked against the data in the ADs (analysis datasets)?

 

Thanks!

Hi,

I use  opencdisc-validator-1.3-usb for BDS files validation, and I received following notice:

SKIP_AD0018 The source data for D:\opencdisc-validator\config/data/ADaM Metadata 1.0.csv is missing and cannot be used for cross-dataset validation

Actually, I have checked the folder and could find the ADaM Metadata 1.0.csv.

May I ask if any one have experience for this stituation? Thanks.

Any comment is appreciated.

 

Wanchi

Hi, it's unclear to me how skips (e.g., subject scheduled for dosing at visits 1, 2, & 3 instead only have actual dosing at 1 & 3) are to be represented in TRxxSDT/TRxxEDT and TRTSEQA. My inclination thus far has been that even though the nominal visit for the 2nd sequence of doses comes from the 3rd visit, I should still only populate TR01SDT & TR02SDT (rather than leaving TR02SDT missing and instead populate TR03SDT). Seems like this sets things up better for APERIOD in the BDS, but I'm open to suggestions.

Hi OpenCDISC support and members,

In the process of validating ADaM datasets and get the following warning message for each dataset.

Rule ID: MISSING_CONFIG

Message: Configuration Unavailable

Category: System

Type: Warning

Searched this site and forums and could not find any reference to this warning.

Appreciate insight on what is causing this warning and consider including in Reviewer's Guide.

Regards,

Song Park

Hi,

I have a question abour rule AD0124: For a given value of parameter code (PARAMCD), all values of parameter catetgory y (PARCATy) should be the same

 

My LB data have both Biochemistry - Glucose and Urinalysis - Glucose test, and I write these two data as below:

Biochemistry - Glucose: PARAMCD=GLUC, PARCAT1=BIOCHEMISTRY

Urinalysis - Glucose test: PARAMCD=GLUC, PARCAT1=URINALYSIS

Dear all,

 

I got following error message:

CRITy is populated and CRITyFL is not populated.

 

Bacause for some visits the CRITy is populated but the value of CRITyFL is missing. Looking at the example on page 77, ADaM IG, it seems that the Null values are permissible, if one part of the condition is not available. I do understand, that it is not so easy to implement this rule, but could you please make some corrections in the next verstion?

Dear all,

I got some warnings and do not agree:

Expected TRTEDT is not present within dataset

Expected TRTSDT is not present within dataset

Right now the validator won't process datasets that are "instance" type, such as ADAE, ADCM, etc. because it won't recognize them without key variables such as PARAMCD, PARAM, etc.  How would we set up a section to recognize the other kind of datasets to run off of a list of the rules (could turn off some of the rules relating to parameter analysis with the attribute setting of Active="No").

Will the validator 1.3 also be generalized to admit datasets that aren't BDS or ADSL?

Thanks very much.

- Joan

Hi... Rule AD0011 may not be working. It's flagging every 0/N ITTFL flag in my file, but they are all OK. My file has ITTFN = 0 if and only if ITTFL = N. Here's what the rule is printing: Variables = ITTFN, ITTFL Values = 0, N Rule ID = AD0011 Message = *FL = N and *FN != 0 The Values= list shows that the values are 0 and N, but the message is saying the flag is N but the value is NOT 0. No other messages are being generated for the flag variables. Thanks, Karen