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- Is there documented guidance on the creation of the sponsor SDTM metadata to be uploaded to Enterprise? In your demo, I noticed populated fields for the Core column differs from the CDISC SHARE SDTM metadata. For instance, CDISC has ‘Req’ and your demo showed ‘Required.’ Are there other differences?
Pinnacle 21 SDTM metadata has the same Core values as implementation guides, except we replaced abbreviations with full values (e.g. Req --> Required) to improve readability. We can provide an example spreadsheet with SDTM metadata that users can use as a template for their own company standards.
- Do you know when FDA will implement Enterprise 3.4 such that they will start to see rules related to ADaM IG 1.1?
FDA began accepting ADaM 1.1 data on March 15, 2018. The latest version of Enterprise and ADaM 1.1 beta rules have already been made available to FDA.
- When there’s a sponsor validation for a CT, does it override the CDISC validation where there is a check for extended terminologies?
Sponsor validation of custom Control Terminology does not override CDISC CT. It is an additional step to ensure compliance with internal standards.
- Will Enterprise still support Define.xml 1.0?
There are no changes to Enterprise Define-XML 1.0 support and functionality. P21 still validates define.xml files utilizing the outdated version of the standard. Our Define.xml Designer tool also assists in converting your old Define-XML 1.0 files into the new Define-XML 2.0 format that is requested by FDA and PMDA.
- Where can we find the 54 non-Programmable rules?
We will make non-implemented rules available as part of our upcoming knowledge base.
- Is it possible to use PMDA 3.0.5 in Enterprise 3.4?
In Enterprise 4.0, users will be able to select different validator engines (e.g., 3.0.5) at the data package level to align to versions being used by health authorities. This functionality is not available in 3.4.
- Does the new datatype check improvements also apply to ADaM 1.0?
Yes, the dataset type detection improvements also apply to ADaM IG 1.0. Note, that OCCDS class was introduced only in ADaM IG 1.1. Therefore, in ADaM 1.0 OCCDS datasets are validated as ADAM OTHER. The only exception is ADAE dataset.
- Using the sponsor-defined standard checks, can we adjust the Severity from ‘Warning’ to Error’ and vice versa?
No, the Severity cannot be modified at this time. Also note that in 4.0 the concept of Severity will be redefined. Error, Warning, and Notice will be reverted to Issue Type, which was the original definition in early versions of the Validator. They specify the confidence in detection of actual issues vs potential issues. FDA and PMDA Severity will be separate concepts with new values of Reject, High, and Low and will be controlled by the agencies. We might also introduce Sponsor Severity to provide the customization you are requesting.
- Should dataset class for ADAE be OCCDS?
A dataset class for ADAE is "OCCURRENCE DATA STRUCTURE".
- Is the Where Clause just for ADaM or can you use this for SDTM as well?
The Where Clause Builder is a new feature available in the Define.xml Designer tool. It can be used for both ADaM and SDTM.
- Would the Data Fitness Scorecard be different if we used the sponsor-defined terminology versus the CDISC standard?
Would you have any webinars explaining the Data Fitness Scorecard changes if any with the Enterprise 3.4 enhancements?
SP checks do not contribute to the Data Fitness Score at this time. Please reach out to your Customer Success team regarding information on Data Fitness scoring, as we have additional information available if you would like additional guidance.
- Along with SP checks, does Enterprise 3.4 provide SD and CT checks? Or all checks combined and output them as SPxx?
SP checks fire concurrently with the existing rules that validate against CDISC standards and controlled terminologies. SP checks do not replace or combine with existing rules.
- “BDS – any dataset with PARAMCD and AVAL” – does this change also identify BDS when PARAMCD and AVALC?
Yes, BDS dataset will be detected based on presence of any of PARAMCD, PARAM, AVAL or AVALC variables.
- We understand that updates for Community will be behind and, as you mentioned, only when approved as final rules. However, there are many issues that are invalid or give erroneous warnings. I know folks have addressed these. Will at least these be fixed any time soon in Community?
We make every effort to resolve bugs and address known issues with each Community release. There are a number of bug fixes/updates for rules in the upcoming Community 3.0. We welcome all feedback for the Community tool on our forum.
- TRTSEQP variable in BDS produces error with regards to label mismatch with data standard. Has this been resolved in the new version?
This bug will be fixed in 3.4.1
- Will the Company rule be displayed in the Reviewer's Guide?
By default, the sponsor-defined checks are not exported since they are optional in FDA submissions. However, this can be a request for enhancement if specified by the client.
- Will the change in the validation checks be applied also in P21 Community, e.g. ADaM IG 1.1?
ADaM 1.1 checks will be added to Pinnacle 21 Community when they are officially published by CDISC (currently expected in December 2018).
- Any plan for having the Reviewer’s Guide fully editable in P21 Enterprise? Once created and we start editing it in word and datasets are updated/changed, the update to the Reviewer’s Guide has to be done manually.
Yes, we have plans for fully editable Reviewer's Guide in Enterprise. However, we are waiting on the results of PhUSE Data Reviewer's Guide in XML project to inform our plans.
- How can we get Enterprise 3.4 on our Test and Prod servers?
Please submit a Service Desk ticket requesting 3.4 upgrade and we will coordinate date and time that is suitable.
- What is the exact purpose of the Global Reviewer's Guide? Can we submit to FDA knowing it contains PMDA checks as well?
Some clients prefer to create a "global" Reviewer's Guide, which can then be used for submission to both authorities. You will still have the ability to export an FDA or PMDA specific Reviewer’s Guide in addition to the Global Export option.
- What is PMDA?
PMDA (Pharmaceutical and Medical Devices Agency) is the Japanese health authority similar to FDA in the USA.
- Are we still going to see our initials and date/time against the comments when we download the Reviewer's Guide from P21 system?
In Enterprise 4.0, we'll introduce ability to manage issue comments and explanations separately, with only the explanations being exported to Reviewer's Guide.
- Can you highlight the difference between Community and Enterprise versions?
In short, Pinnacle 21 Community is a free, desktop, open-source tool for assessing standards compliance. Pinnacle 21 Enterprise builds on top of Community and introduces additional cloud-based collaboration tools such as Issue Management, Define.xml Designer, sponsor standards validation, and much more. For additional information, please visit our website (www.pinnacle21.com) or contact us at firstname.lastname@example.org.
- Where can we get the template for sponsor's terminology? Please follow these steps:
1) Make sure the user has Standard Designer role
2) Navigate to Manage Metadata -> Terminologies page
3) Click on the green "+ Import Terminology" button
4) On the Import dialog, click the "download it here" link for template
Similar steps can be followed under Standards page for Standards template
- Out of the 356 "Programmable" SDTM validation checks in 3.2, how many of those are implemented in the Pinnacle 21 Community version?
P21 Community is driven by officially published checks (FDA, PMDA and CDISC). Therefore, all SDTM checks published by CDISC and implemented by Pinnacle 21 team will be available in both Community and Enterprise versions of the Validator.
- Will you be updating the current version of the Pinnacle 21 Community (2.2.0)?
Yes, a new Community version 3.0 is coming soon. It has all officially published checks (FDA, PMDA and CDISC) implemented by Pinnacle 21 team. Unpublished checks like the beta version of ADaM IG 1.1 rules will not be available in P21 Community until they are officially released.
- When we upload XPT files, Does Pinnacle pick the Variable Datatype ADAM standards or from the XPT files?
We assume that the question is about importing study datasets into the Define.xml Designer tool. P21 Define.xml Designer identifies variable datatype using both the XPT dataset metadata as well as the ADaM standard. However, attributes of actual study data overwrite the standard in case of any conflict. For example, if *DTC variable is SAS Char datatype and follow ISO8601 Regex expression, a define.xml tool assumes that it ODM "datetime" Data Type (*DTC, Char, ISO8601). If there is no conformance with ISO8601 format, then this variable will be considered as "text". If *DTC variable is SAS Num datatype, it will be identified as either "integer" or "float" based on actual data.
- How do we deal with current ADAM 1.1 false positives, e.g., Label Description is incorrect. my current study score is low because of this?
Versions prior to 3.4 of Enterprise do not support validation of ADaM-IG 1.1. Upgrade to 3.4 to avoid false positives.
- You just showed us that we can import the sponsor template as well as P21 template, if we choose the first one, do we need to follow the tabs you have like datasets, value level metadata, etc.
Pinnacle 21 Enterprise can be customized with a metadata import adapter, which will upload standards and terminologies in client format. For additional information, please contact us at email@example.com.
- You mentioned not all CDISC rules are implemented in P21, is there a list somewhere we can see what rules are not implemented, so that we can check ourselves?
We will make these rules available as part of our upcoming Help Center.
- How long after CDISC formally releases ADaM 1.1 rules can we expect to see them in Enterprise?
A beta implementation of ADaM-IG 1.1 rules is available in P21 Enterprise 3.4. We will continue implementing ADaM rules in parallel to CDISC team efforts to ensure the final implementation is available at the same time as the CDISC official publication, planned for December 2018.
- Will you be deploying the ADaM 1.1 beta rules to FDA and PMDA?
The latest version of Enterprise and ADaM-IG 1.1 beta rules have already been made available to FDA. PMDA will likely start using ADaM-IG 1.1 validation with Enterprise 4.0 release.
- Where will the beta rules be posted?
Beta rules will be available under the Rules tab of each standard.
- Are you anticipating any more ADaM 1.1 beta rules to be released before CDISC formal rules?
Yes, the CDISC team effort is not yet complete, so additional rules are possible. Also, FDA and/or PMDA may add additional business rules before the formal release. We'll keep updating our beta implementation with new rules as they become available.
- Is there any relationship between SPxxxx rules and MDxxxx rules?
MD (Metadata) rules validate custom standard to evaluate their structure and consistency with base CDISC standards. SP (Sponsor) rules validate the data against the custom standard.