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Resources

ClinicalTrials.gov:

  • General ClinicalTrials.gov Information [1]  
  • Summary Table of FDAAA 801 and NIH Policy on Clinical Trials Registration and Reporting [2]
  • ClinicalTrials.gov Registration and Results Reporting Decision Tree [3]

WMA Declaration of Helsinki:

  • Update on [4]WMA Declaration of Helsinki [5] – Ethical Principles for Medical Research Involving Human Subjects, Paragraph 35 and 36, released October 2013

NIH:

  • Office of Extramural Research (OER) [6] 
  • Frequently Asked Questions for NIH Grantees [7] 

ICMJE:

  • ICMJE Clinical Trial Registration [8]
  • ICMJE Questions About Clinical Trial Registration [9]
  • ICMJE Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals [10]

Note: ICJME and many other journals have information regarding clinical trial registration in their Instructions for Authors section.

  • Center for Medicare & Medicaid Services (CMS) [11] (PDF): Mandatory Reporting of an 8-digit Clinical Trial Number on Medicare & Medicaid Claims

FDA:

  • Center for Drug Evaluation and Research; US Food and Drug Administration: "Guidance for Industry Information Program On Clinical Trials For Serious Or Life-Threatening Diseases And Conditions" [12] (PDF)

WHO:

  • WHO International Clinical Trials Registry Platform (ICTRP) [13]

NLM:

  • National Library of Science and Medicine ClinicalTrials.gov Questions [14]

Hints For ClinicalTrials.gov Users 

How To Avoid Common Problems When Using Clinicaltrials.Gov In Research: 10 Issues To Consider [15] (bmj.com)

 

 

 

 


Source URL: https://orra.rutgers.edu/ctglinks

Links
[1] http://www.clinicaltrials.gov/
[2] https://orra.rutgers.edu/sites/orra.rutgers.edu/files/HSPP/Auditors/Summary%20Table%20of%20FDAAA%20801%20and%20NIH%20Policy%20on%20Clinical%20Trials%20Registration%20and%20Reporting%202017-7-11.pdf
[3] https://orra.rutgers.edu/sites/orra.rutgers.edu/files/HSPP/Auditors/CT.gov%20decision%20tree_20170605%20-%202017-7-11.pdf
[4] https://prstest.nlm.nih.gov/
[5] http://www.wma.net/en/30publications/10policies/b3/index.html.pdf?print-media-type&footer-right=[page]/[toPage]
[6] http://grants.nih.gov/Clinicaltrials_fdaaa/
[7] http://grants.nih.gov/Clinicaltrials_fdaaa/faq.htm
[8] http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
[9] http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/
[10] http://www.icmje.org/icmje-recommendations.pdf
[11] http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R2955CP.pdf
[12] http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126838.pdf
[13] http://www.who.int/ictrp/en/
[14] http://www.nlm.nih.gov/services/faqctgov.html#info
[15] https://www.bmj.com/content/361/bmj.k1452