SDTM Example. Product Description -HPHC Testing

ISSUE: 

1. I think we need to make STRFID domain specific . That is use PTSTRID.  This allow different reference Id to be used across domains. I think here you can use CAS, but in ingredients this does not work.  IS it ok to keep , this meta example for the REFID. WE need to confirm with Richard how to describe.  
2. Need to clean up TL.  SHould , we allow the ability to create look ups for UNI, etc. or delete and jsut show test condition for now. 
3. Neew to agree that PT is product testing domain name, and not Tobacco Product Testing. Should we create a model class of Product testing- and then allow domains by product in the future. .  

The following example illustrates how to represent results from HPHC testing of a tobacco product under study using the Product Testing (PT) domain. This testing is conduct on samples of the product of interest, and if applicable samples of comparison products. Each product tested would have it's own unique sponsor-defined value for SPTOBID to identify the product. 

This example only shows test results for each constituent for one sample of one product that was tested. The sampling plan and testing plan including the number of samples of the products tested are determined by the sposnor. In reality, sponsors would have multiple product samples tested and those would be distinguished in the dataset. These sample identification information may be represented in PTREFID, and/ or PTSPID. In this example, SPTOBID indicated the product identification, and each sample of that product was numbered as Sample 1 thru Sample n. Many sponsor may use more specific codes to identify the source of product sample.          

This is the example meta data that the sponosr would include to describe the published references used to report STRFID. 

Example PT  Variable Metadata TOBA-11 - Getting issue details... STATUS

Example External Dictionaries

The Trial Lookup table can be used to provide additional details on any test conditions or methods used to perform the testing. 

 Additionally, TL can be used to provide different chemical reference information  that may  be used associated with the the substance ingredient. These different chemical substance reference numbers/codes are available in many published dictionaries, and may not be needed. This was used by the sponsors convenience only.