When it comes to clinical and nonclinical study submission datasets to the FDA or PMDA there are multiple validation tools available. This article tells about eDataValidator (eDV) which is a strong and complete validation tool for both clinical and nonclinical studies. A single solution for IND, NDA, and BLA preparation, eDV allows unlimited validation of Clinical SDTM and ADaM as well as Nonclinical SEND.
Supported Validation Rules by PointCross
FDA Validator Rules v1.5
FDA Validation Rules provide details regarding FDA’s assessment of study data for purposes of review and analysis. A business rule, a standard, or the Study Data Technical Conformance Guide must all meet certain requirements in order to be considered compliant with an FDA Validator Rule. Additionally, the validation requirements reflect the most recent knowledge of what best facilitates regulatory review.
PMDA Validation Rules v2.0 (SDTM, ADaM)
The relevance of PMDA Validation Rules is divided into three categories:
- Reject rules that, if broken, will result in the suspension of the review until the corrections have been completed.
- Error rules that, if broken without a justification, will result in the review being suspended until the errors have been fixed.
- Warning rules that, even when violated, don’t always call for an explanation.
CDISC SEND Conformance Rules v4.0
The SEND Conformance Rules v4.0 are meant to serve as a guide for the organisation, structure, and format of standard non-clinical tabulation datasets for exchange between organisations, such as sponsors and CROs, as well as for submission to regulatory authorities when used in conjunction with the SEND Implementation Guides.
The SEND Conformance Rules version 4.0, are a compilation of the most recent publications as well as older ones that cover SENDIG versions through 3.1.1 and SENDIG-DART v1.1. The most recent rules for assessing the compliance of SENDIG-DART v1.1 datasets are contained in SEND Conformance Rules v4.0, which are also meant to assess the conformance of SENDIG v3.0, v3.1, and v3.1.1 datasets.
CDISC SDTM Conformance Rules v1.1
Version 1.1 of the Study Data Tabulation Model (SDTM) and its Implementation Guide (SDTMIG) Conformance Rules includes a minor version update to the Conformance Rules for SDTMIG v3.2 as well as the initial release of the Conformance Rules for SDTMIG v3.3. Users are able to assess how closely the data structure adheres to the standard using CDISC Conformance Rules.
CDISC Define Conformance Rules for 2.0 & 2.1
The Define-XML Conformance Rules for version 2.1 are meant to help implementers create Define-XML documents that adhere to the specifications set out in the Define-XML Specification and its accompanying XML schema. The Define-XML documents given for SEND, SDTM, and ADaM submissions to international regulatory authorities will be more consistently formatted thanks to the Conformance Rules.
FDA Rejection Criteria (FDA TRC Rules)
The FDA has created tools to assist sponsors in meeting revised study data standard specifications and to increase validation process transparency. Technical Rejection Criteria (TRCs) have been officially adopted by the FDA, and if your Electronic Technical Document (eCTD) package fails any of the TRCs, the TRC may now block your submission.
PointCross Extended checks
To confirm compliance to the SEND standards for study types modelled in an FDA certified SEND Implementation Guide (SENDIG) edition, the TRC has been added to the existing eCTD validation criteria. PointCross Validation engine have already been extended to ensure that all datasets are checked against the Technical Rejection Criteria.
CDISC ADaM Conformance Rules v4.0
The ADaM Conformance Criteria, version 4.0, provide more than 1000 rules that can help confirm that ADaM datasets have been built in a way that is consistent with the applicable ADaMIG. The development of software to carry out ADaM dataset checks is also made possible by the ADaM Conformance Rules v4.0. The purpose of the ADaM Conformance Rules v4.0 is for single studies only.
PMDA Validation Rules v3.0 (Define)
The Japanese Pharmaceutical and Medical Devices Agency (PMDA) released its eagerly anticipated update to the Validation Rules for SDTM, ADAM, and Define-XML on December 15th, 2021. PMDA Validation Rules 3.0, also known as PMDA Engine 2010.2, made numerous updates, including support for ADaM-IG 1.1 and new standard conformance rules from CDISC.
Why use PointCross Clinical & Nonclinical Validation Tool (eDataValidator)?
- Validate all SDTM, ADaM, and SEND files in any format against the final and interim research data (CSV, XPT, SAS7BDAT, EXCEL)
- Validate Define.xml with PMDA & CDISC Define validation rules (versions 1.0, 2.0, 2.1).
- Verify research data against all CDISC CT versions that have been released as well as external dictionaries and proprietary CTs.
- Integration of existing applications using CLI
- Verify the structural and metadata accuracy of study datasets by performing data consistency checks.
- Generate draft SDRG template for SEND and SDTM
- Generate define files (as a service)
- XPT datasets being converted to Excel format