In August 2020, we released our new Pinnacle 21 validation engine “FDA (1907.2)” for preparing study data for FDA submissions. It includes the validation rules currently used by FDA’s DataFit, the agency’s implementation of Pinnacle 21 Enterprise.

The previous, outdated version of the validation rules is represented by our “FDA Legacy (1903.1)” engine. It will be available for the next few months until our next release. This window allows you to finalize your ongoing submission preparations.

Note: We advise you to use “FDA Legacy (xxxx.x)” engines only for submissions you will file in the next few months. Please do not use legacy engines for future submissions, as outdated engines may be retired at any moment.

Update and Installation

As explained in our update process, our new engine “FDA (1907.2)” is automatically uploaded to all Pinnacle 21 Community 3.0.x versions that are using a Pinnacle ID and have internet connection. Otherwise, you will need to download and reinstall Pinnacle 21 Community v3.0.2 from our website.

Application Updates

For details, please see the CHANGELOG.txt file in this folder:

C:\Users\%USERPROFILE%\AppData\Local\Programs\pinnacle21-community

Validation Rule Updates

This summary highlights changes to the validation rules in the new engine “FDA (1907.2)” compared to the previous engine “FDA Legacy (1903.1)” available in P21 Community. For complete details, please see the CHANGELOG.txt file in this folder:

C:\Users\%USERPROFILE%\Documents\Pinnacle 21 Community\configs

SDTM Validation

• Added 15 new rules, including validation of WHODrug coding and presence of the new Trial Summary Parameters required by the FDA: SD1344, SD1345, SD1346, SD1347, SD2273, SD2274, SD2275, SD2276, SD2277, SD2278, SD2279, SD2280, SD2281, SD2282, SD2285
• Removed 3 rules: SD1145, SD1259, SD1281
• Modified algorithms for 9 rules to reduce false-positive messages and improve issue diagnostics: SD0080, SD0082, SD0084, SD1117, SD1201, SD1236, SD1260, SD1318, SD2237

ADaM Validation

• Added 3 new rules: AD0142, AD0320, SD1071

SEND Validation was revised and tuned per new FDA requirements. Please see our blog post and webinar about these recent changes: How We Improved the SEND Validation Rules.

• Added 22 rules: SD1111, SD1201, SD1245, SD1246, SD1250, SE1148, SE2228, SE2229, SE2230, SE2231, SE2232, SE2329, SE2330, SE2331, SE2332, SE2333, SE2334, SE2335, SE2336, SE2337, SE2338, SE2339
• Removed 2 rules: SD1013, SD1148
• Modified algorithms for 9 rules: SD0082, SD0084, SD1117, SD1201, SE2310, SE2320, SE2322, SE2323, SE2324
• Extended assignments to additional domains for 15 rules: SD0001, SD0005, SD0037, SD0062, SD1063, SD1228, SD1229, SD1230, SD1231, SD1324, SD1325, SE2320, SE2322, SE2323, SE2324