Compliance Commitment
Please read these terms and conditions of use carefully before using this Novo Nordisk Inc site. By using a Novo Nordisk Inc. site and any third-party site that is linked to a Novo Nordisk Inc. site you signify your agreement to these terms. Novo Nordisk Inc. reserves the right to change, modify, add, or remove portions of these terms. Please check these terms periodically for changes. Your continued use of a Novo Nordisk Inc. site following the posting of changes to these terms will mean that you accept those changes.
Novo Nordisk Inc. sites are produced, owned and operated by Novo Nordisk Inc. and its parent company, Novo Nordisk A/S, and are protected by copyright and trademark laws. All materials contained in any Novo Nordisk Inc. site are the copyright property of Novo Nordisk Inc. or its parent company, Novo Nordisk A/S, or its subsidiaries or affiliate companies and/or third-party licensors. Novo Nordisk Inc. is one subsidiary of Novo Nordisk A/S among other companies in the Novo Nordisk group of companies. Neither these affiliate companies nor the parent company can be held responsible, either directly or indirectly, for any harm, damage or inconvenience that might arise from the use of this site, or from your reliance on any information or materials provided on this site, or any third-party site linked to or from this site.
All trademarks, servicemarks and tradenames are proprietary to Novo Nordisk Inc., its parent company or its affiliates. No material from any Novo Nordisk Inc. site owned, operated, licensed, or controlled by us or our affiliates or parent company may be copied reproduced, republished, uploaded, posted, transmitted, or distributed, in any way, except that you may download one copy of the materials or forward pages from this site, you must (i) not alter any copyrights or other proprietary notices, (ii) make no modifications to the materials, (iii) you may not use the materials in a manner that suggests an association with any of our products, services or brands, and (iv) you may not download quantities of materials to a database that can be used to avoid future downloads from any Novo Nordisk Inc. site. For purposes of these terms, the use of any such material on any other website or computer environment is prohibited.
Novo Nordisk Safety Reporting Requirements Policy
Obligations and responsibilities of the Sponsor-Investigator related to safety reporting
When reporting Adverse Events the following parameters must be recorded:
a) Reporting to Health Authorities
The Sponsor-Investigator shall be responsible for all required periodic updates to health authorities and expedited reporting of Adverse Events occurring during the performance of the study, in accordance with local regulations and the agreed protocol.
The approving Health Authority may:
Sponsor-investigators have obligations for reporting of relevant serious adverse events (SAE) information to the Competent Authority and Independent Ethics Committee/ Institutional Review Boards based upon federal regulations and Local/IRB policies.
b) Reporting to Novo Nordisk
For all IIS studies, when the Principal Investigator is aware that the study subject has been exposed to a Novo Nordisk product (including placebo, if supplied by Novo Nordisk), the following information must be reported in English to Novo Nordisk:
All individual Serious Adverse Drug Reactions (SADRs) shall be sent to Novo Nordisk within the same timeline as if they were reportable to regulatory authorities.
Report any pregnancy in the study subject that occurs during the use of a Novo Nordisk product.
Reporting the SAE to Novo Nordisk does not relieve institution and/or Principal Investigator of the responsibility for reporting it to the FDA or Local Regulatory authority, as required.
I certify that the statements made in this request application are true, complete and accurate to the best of my knowledge.
By clicking here, you have read, understand and agree to all of the above terms and conditions.
©2019 SteepRock Inc. All Rights Reserved.