ADaM 1.1 configuration file?

Pinnacle 21 Support ADaM
1

Isn’t this done automatically?
E.g.. that at each startup, the tool uses a (RESTful) web service to check on the Pinnacle server whether there are updates for configuration files, bug fixes, rule fixes, etc..
In such a way, errors could be fixed within a few hours after being reported and fixes/updates made available within minutes after the changes were made and tested.

This is the way that other validation tools work for always being up-to-date.

2

I don’t believe CDISC has published validation checks for v1.1 and I don’t think the FDA is has added it to the Data Standards Catalog yet.

Does anyone know when the FDA will start accepting ADaMIG v1.1?

3

Hi,

The FDA supports ADaM IG 1.1 since March 15, and ADaM IG 1.0 support will end on March 15, 2019 & 2020 : is there any date scheduled for 1.1 support by Pinnacle 21?

Cheers
– Thierry

4

Hi Thierry,

For Pinnacle 21 Community to add validation support for ADaM 1.1, we first need CDISC to publish the rules. Currently, CDISC plans to publish in August-September for public review and publish final rules in December. We will try to release a new version of Pinnacle 21 Community as soon as the rules are finalized.

Regards,

Sergiy

5

Hi,

I need ADAM V1.1 configuration file to run Pinnacle 21 validation report. Can anyone please suggest from where I can download the same.

Thanks a lot !

6

Hi,

Can anyone please confirm if ADAM v1.1 configuration file is available to run Pinnacle report.

Thank you,

7

Hi Parul,

ADaM IG 1.1 specifications will be available only in the next Community release 3.0.0 in early May.

Kind Regards,

Sergiy

8

Dear Sergiy,

Thank you so much for the quick confirmation ! Looking forward for updated release in May.

Kind Regards,

Parul

9

Hi Sergiy,

Slightly worrying that your comment has been changed 4 times now, first February, then March, then April and now May.

Thanks
Craig

10

Yes, I am also not very happy with this. Unfortunately, there are too many dependencies including some of them outside of Pinnacle 21.

Kind Regards,

Sergiy

11

Hi,

I ran the latest version of Pinnacle 21 on my ADaM datasets and realized that the tool wasn’t compliant for ADaM IG 1.1.

I received errors for labels mismatches, especially “Datetime” variables label. It seems like the wording “Date/Time” was changed to “Datetime” in some variables.

Can we expect any time soon the ADaM IG 1.1 configuration file to be available?

Thanks

Pierre Dostie