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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:
- Study name
- Patient identification (e.g. subject number, initials, sex, age)
- Event (preferably a diagnosis)
- Drug (e.g. Norditropin Simplex®)
- Reporter identification (e.g. name, or initials)
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:
- Have special requests beyond Serious Unexpected Suspected Adverse Reaction (SUSAR) reporting
- Allow not to unblind and expedite specific SUSARs
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.
- SADRs include all SAEs which are probably or possibly related to any Novo Nordisk product.
- Indicate on any SADR whether it has been submitted to local health authorities.
- In addition to SADRs, any other events that have been submitted to the health authorities according to local regulatory requirements in the participating country shall be sent to Novo Nordisk at the time of submission to health authorities.
Report any pregnancy in the study subject that occurs during the use of a Novo Nordisk product.
- Pregnancies include pregnancies that occur in patients receiving Novo Nordisk products or pregnancies that occur in trial subject's partners whose foetus or baby develops an adverse event considered to be related to the trial product.
- SADRs and pregnancy reports are to be reported to Novo Nordisk via the approved Local Regulatory form (i.e FDA Medwatch form, CIOMS, etc.) An Event Fax Cover sheet will be provided by Novo Nordisk.
- Reportable Events subject to this provision are those that occur from the first dose of Novo Nordisk product, through the specified time period described in the protocol.
- The Principal Investigator shall provide further information about safety related events to NN, if the Principal Investigator receives specific requests from Novo Nordisk.
- The Principal Investigator also agrees to assist Novo Nordisk with follow-up of only SAE Reports.
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.
- The Sponsor-Investigator agrees to the terms of Novo Nordisk safety reporting policy for IIS Studies.
- The Sponsor-Investigator agrees to comply with Adverse Event reporting required by federal regulations and Local/IRB policies.
- Should Novo Nordisk agree to providing funding and/or drug for my IIS, I agree to Register the Trial Information, Status and results under applicable rules on clinicaltrials.gov and other Relevant sites.
- The protocol describes the ethical principles under which the study will be conducted (e.g. ICH, GCP), the manner in which the study will be reviewed by IRB/IACUC, and the procedures for obtaining informed consent.
I certify that the statements made in this request application are true, complete and accurate to the best of my knowledge.
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