Volume 27, Issue 2 - Public Disclosure

Clinical trial results disclosure on ClinicalTrials.gov and EudraCT

Author: Holly Hanson

Abstract

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References

1. Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). Available from Available from: https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission
2. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Available from: Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
3. Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801). Available from: Available from: https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=82
4. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. Annals of Internal Medicine. Editorial published at Annals.org on 6 June 2017. Available from: Available from: http://www.icmje.org/ news-and-editorials/data_sharing_ june_2017.pdf.
5. FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results. DeVito NJ, Bacon S, Goldacre B; EBM DataLab, University of Oxford. Available from: Available from: https://www.biorxiv.org/content/biorxiv/early/2018/02/20/266452.full.pdf
6. Clinical trial assignment request template letter and template instructions. Available from: https://eudract.ema.europa.eu/ result.html.
7. ClinicalTrials.gov Results Data Element Definitions for Interventional and Observational Studies. June 29, 2017. Available from: Available from: https://prsinfo.clinicaltrials.gov/results_definitions.html#Result_Baseline
8. EMA Q&A – EudraCT Results training – session 16th December 2014. Available from: Available from: https://eudract.ema.europa.eu/docs/training/Questions%20from%20the%20V10%20workshop_16Dec2014.pdf
9. EMA EudraCT V9 Workshop – Managing users and prepare results in EudraCT, 15th November 2013. Q&A documents. Available from: Available from: https://eudract.ema.europa.eu/docs/training/List%20of%20questions%20from%20V9%20Workshop_15November13.pdf
10. EudraCT result related data Dictionary. Available from: Available from: https://eudract.ema.europa.eu/result.html
11. Regulation (EC) No 1901/2006. Available from: Available from: https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf
12. Regulation (EC) No 1902/2006. Available from: Available from: https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2006_1902/reg_2006_1902_en.pdf
13. Commission Guideline 2009/C28/01. Available from: Available from: https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-10/2009_c28_01/2009_c28_01_en.pdf
14. ClinicalTrials.gov PRS Results Schema. Available from: Available from: https://prsinfo.clinicaltrials.gov/prs-xml-schemas.html
15. EudraCT XML schemas and documentation. Available from: Available from: https://eudract.ema.europa.eu/result.html