SD2264: Invalid TSVALCD value for PCLAS - POTASSIUM CHLORIDE

Sergiy

on January 6, 2021

P21

Hi Manolya, Only some of…

Hi Manolya,

Only some of component concepts are applicable per FDA specifications. 'POTASSIUM CHLORIDE' is not in that list.

According to FDA Study Data Technical Conformance Guide (https://www.fda.gov/media/136460/download): 

"Pharmacologic class is a complex concept that is made up of one or more component concepts: mechanism of action (MOA), physiologic effect (PE), and chemical structure (CS).51 The established pharmacologic class is generally the MOA, PE, or CS term that is considered the most scientifically valid and clinically meaningful. Sponsors should include in TS (the full TS) the established pharmacologic class of all active moieties of investigational products used in a study. FDA maintains a list of established pharmacologic classes of approved moieties.52 If the established pharmacologic class is not available for an active moiety, then the sponsor should discuss the appropriate MOA, PE, and CS terms with the review division. For unapproved investigational active moieties where the pharmacologic class is unknown, the PCLAS record may not be available."

'POTASSIUM CHLORIDE' term does not have associated component concept value in NDF-RT. Therefore, it is excluded from a list of valid terms during validation.

I would recommend you to use newer MED-RT dictionary and follow-up with your Clinical team on correct options for this parameter. Examples of potentially valid terms are:

• Potassium Channel Agonists [MoA]    N0000175449    MED-RT
• Potassium Channel Interactions [MoA]    N0000000211    MED-RT
• Potassium Channel Antagonists [MoA]    N0000175448    MED-RT
• Potassium Channel Openers [MoA]    N0000182728    MED-RT

Kind Regards,

Sergiy

NDF-RT vs FDA approved list

Hi Sergiy

Thanks for your thorough input. So if I understood correctly, FDA has another approved list of PCLAS that do not have all PCLAS that are available in NDF-RT? Is this the "FDA Established Pharmacologic Class (EPC) Text Phrase"? Thus, checking the NDF-RT list is not always correct?

Best

Manolya