|
Novo Nordisk principles for clinical trials Novo Nordisk sponsors clinical trials in healthy volunteers and in patients as part of the global clinical development programmes needed to document safety and efficacy of new drugs and devices before marketing authorisation, or to document safety and efficacy in new indications or labelling changes following the primary marketing authorisation. Furthermore, Novo Nordisk sponsors clinical trials after marketing authorisation has been obtained in order to gain additional clinical experience with a marketed compound or device. This document describes: - Principles for the conduct of Novo Nordisk sponsored clinical trials and investigator sponsored trials with Novo Nordisk trial products to ensure the safety, rights, integrity, confidentiality and well-being of trial subjects.
- The quality system implemented to ensure that data are generated, verified, managed, interpreted and reported in compliance with external guidelines and regulations.
ScopeAll activities related to the conduct of clinical trials sponsored by Novo Nordisk as well as Investigator sponsored trials where Novo Nordisk provides trial product and/or financing and/or technical support. Definitions- Clinical Trial
Any investigation in human subjects intended to evaluate the clinical, pharmacological, other pharmacodynamic effects, and/or to identify any adverse reactions to investigational product(s).
- Investigator
A person responsible for the conduct of the clinical trial at a trial site. For investigator-sponsored trials the investigator assumes full responsibility for the initiation and conduct of the trial and the treatment of the trial subjects.
- Sponsor
An individual, company, institution, or organisation which takes responsibility for the initiation, management, and/or financing of a clinical trial.
- Trial Subject
Either a healthy subject or a patient.
Principles- Novo Nordisk will observe external guidelines and regulations having their origin in the Nuremberg Code, The Declaration of Helsinki, other ethical guidelines, local laws and in the principles of current GLP, GCP, and GMP.
- Novo Nordisk will strive to:
- Ensure global exposure of investigational products observing ethical, scientific and cultural standards.
- Ensure the safety, rights, integrity, confidentiality and well being of trial subjects by applying proper scientific and ethical values.
- Ensure that the interests and well being of the trial subjects will always prevail over interests of science, society and commerce.
- Ensure that all trial subjects participate voluntarily in clinical trials through appropriately provided subject information and freely given informed consent. Subjects can always withdraw without providing a reason during a trial.
- Ensure that special concern is directed towards vulnerable trial subjects (including children, elderly, unconscious, and mentally incapacitated).
- Ensure that Novo Nordisk employees do not participate in Novo Nordisk sponsored clinical trials.
- Ensure proper indemnification of trial subjects in case a trial product or procedures in a Novo Nordisk sponsored trial causes bodily harm to a trial subject.
- Ensure preparation of clear and detailed protocols based on ethical considerations and that these protocols are always approved by independent ethics committees.
- Ensure that trials are initiated only if scientifically and medically justified and with due respect to the interests, safety and well being of the trial subjects.
- Ensure that the number of enrolled subjects will be based on sound scientific, medical and statistical considerations.
- Ensure that clinical pharmacology exploratory trials are based on sound rationale.
- Ensure that placebo controlled trials are conducted only if scientifically and ethically justified. The trial subjects must always be informed about possible consequences of the placebo treatment.
- Ensure that trials intended to show the safety and efficacy of the investigational product will only be extended if scientifically and ethically justified.
- Ensure that staff involved in executing Novo Nordisk sponsored clinical trials are appropriately qualified.
- Ensure that appropriate subject safety information is continuously assessed during a Novo Nordisk sponsored trial and that appropriate actions are taken if the risk of the trial product outweighs the benefit.
- Ensure that any product used in Novo Nordisk sponsored clinical trials is manufactured and controlled according to international and local standards.
- Ensure accurate and timely generation, verification, handling, interpretation, and reporting of all data and results from Novo Nordisk sponsored clinical trials.
- Ensure publication of Novo Nordisk sponsored clinical trials takes place according to accepted international guidelines.
Quality System- Novo Nordisk will maintain a quality system to ensure compliance with the above principles and the corporate Novo Nordisk Quality Manual, including:
- Approval of the project by the Research Committee or Therapeutic Area Development Committee must be obtained before initiation of any clinical activities for New Chemical or Biological Entities.
- Approval by the Safety Committee must be obtained before the first clinical trial is initiated in human beings.
- Preparation of updated Clinical Development Plans to ensure that appropriate clinical trial strategies and activities are aligned with Product Business Plans.
- Availability of current Standard Operating Procedures (SOPs) addressing all aspects of clinical trial related activities:
- Mandatory SOPs applicable to Novo Nordisk worldwide to ensure harmonisation and consistency in the global conduct of clinical trials.
- Mandatory SOPs applicable on a department/affiliate level to ensure compliance with national regulations.
- Assurance that external guidelines and regulations are incorporated into the Novo Nordisk quality system in a timely manner.
- Documented qualification of Novo Nordisk clinical research staff by education, training, and experience.
- Clinical trial protocols that are clear, detailed and where an internal Protocol Review Committee or Local Trial Registry reviews the scientific and ethical quality before external mandatory review and approvals.
- Clinical trial reports that are clear, detailed and where an internal Report Review Committee reviews the scientific and regulatory quality.
- Clinical Quality Assurance will perform independent audits on all aspects of Novo Nordisk sponsored clinical trials.
- Documentation related to clinical trials will be filed appropriately and be available for inspection by regulatory authorities.
|
