Research and Publications

Methodology, papers, evaluations and how to cite them.

Everything here carries its real status. A paper is called submitted, accepted, presented or published only after that has happened, and no DOI or publication record is listed until one exists.

Methodology

CDRN Framework documentation

Item	Version	Status	Access
CDRN Framework: methodology, rules and limitations	1.0	Published on this site	Read online · Download (Markdown)
Illustrative scenario: database lock readiness	1.0	Published on this site	Open
Clinical Statistical Programming Operations: A Practical Leadership Handbook	Working edition 0.1	Drafts: 3 author drafts, 9 awaiting author review	Read

Technical papers

Papers and conference contributions

New entries are added to this list as they progress; the page does not need redesigning to add them.

Title	Venue	Status	Notes
Beyond Percent Complete: A Structured Operational Readiness Framework for Clinical Statistical Programming Milestones	Proposed for PharmaSUG	In preparation	Not submitted. Will describe CDRN Framework v1.0, its rules and the design of the independent evaluation. Status will be updated only when the paper is submitted, accepted or presented.

Conference presentations: none yet. Peer-reviewed journal articles: none yet.

Independent evaluation

Evaluations and validation findings

No independent evaluation has been completed and there are no validation findings to report. The pre-specified evaluation design, the scenario catalogue and the current status are on the validation page. Practitioners can register as reviewers. Results will be published here and on the validation page whatever they show.

Independent citations and external references

None are listed yet. An external reference is listed only after it has been checked and can be linked.

Supporting resources

Templates and checklists (Excel and CSV), including the three Handbook chapter templates.
Glossary of readiness and clinical data terms used on this site.
Handbook references: the standards, guidance and literature the chapters cite.

Citation

Cite the version you used.

Gogu, Shiva Kumar. CDRN Framework, version 1.0. Clinical Data Readiness Navigator. https://www.clinicaldatareadiness.org/methodology.html. Accessed [date].

Gogu, Shiva Kumar. Clinical Data Readiness Navigator, version 1.0. https://www.clinicaldatareadiness.org. Accessed [date].

Machine-readable software citation: CITATION.cff in the project repository. More formats on the Citation page.

Version history

All material changes to the methodology and the platform are recorded in the changelog.