Does Pinnacle Community version support PGx domains?

Pinnacle 21 Support SDTM
1

Hi Vidya,

No, today Pinnacle 21 does not support PGx domains.

  • There is no business interest. You are probably the first one who asked about this functionality
  • There are no requirements or requests from FDA or PMDA to support this standard
  • CDISC is considering to incorporate PGx domains into SDTM IG in the future

Kind Regards,

Sergiy

2

Well actually, I have the same problem. More and more studies involve genome and the PGX domains should be supported by Pinnacle in my opinion. I guess the only option is to document the problem in the Reviewer Guide.

3

We are also trying to map Pharmacogenomic data, and a working standard will be very helpful.

4

Officially, there is no CDISC standard for PGx domains today

5

The formal status at CDISC is that it is a “provisional standard currently under CDISC review”.
See Genomics | CDISC

6

For almost 5 years now

7

Hi,

We are mapping genomic data for a client and the genomic data is from a vendor.

I have the following questions:

  1. If we use any of the PGx domains to map the genomic data (in any of the BE, PF, PB, BS, PG, SB domains), we get Pinnacle errors.

  2. Does Pinnacle Community version not support PGx domains?

  3. Since the SDTM datasets have to go through Pinnacle validation, what should be done for validating PGx domains?

  4. Do we instead need to map PGx to other custom domains or map the PGx domains to LB domain?

Thanks,

Vidya