Information for our partners and suppliers
Our General Terms of Delivery define the core conditions governing every partnership and become binding upon purchase order acceptance.
Information for our partners
General Terms of Delivery of the Zentiva Group form basic conditions on which Zentiva and a second party are entering and performing their business relationship. General Terms of Delivery are a non-separable part of each Purchase order of the Customer and at the moment of the acceptance of the Purchase Order they are binding for both parties.
- Binding Terms and Conditions of the occupational health and safety, fire prevention and environment protection, applicable to the contractors operating in the Zentiva, Inc. site | PDF file, 95 KBDownload
- Code of Ethics | PDF file, 870 KBDownload
- Economic Sanctions Requirements | PDF file, 516 KBDownload
- General Terms of Delivery, Zentiva Group | PDF file, 216 KBDownload
- HSE Policy | PDF file, 334 KBDownload
- Supplier Code of Conduct | PDF file, 366 KBDownload
Reporting issues is a valuable contribution to the safety and wellbeing of trial participants and consumers. Thank you for following this guide.
There are two responsibilities: IDENTIFY and COMMUNICATE any case of suspected fraud, misconduct, or serious breach. Such actions may be identified and informed by anyone involved: investigator, site staff, contractor, CRO, third party, sponsor staff
IDENTIFY
Fraud
Always intentional falsification of data in proposing, designing, performing, recording, supervising, reviewing or reporting research.
Examples of fraud warning signs: accrual of too many participants in a short time; data that are reported more efficiently by one investigator than other investigators; difficulty in scheduling site visits / failure to adhere to the protocol visit schedule; attempts to limit document access, reluctance to provide full and complete source documentation as per GCP requirements; doubts about the authenticity of the handwritten informed consent signature; major failure to the ALCOA principle; major and repeated drug accountability issues; creation of source data for non-existing patients or non-existing procedures; filling in the eCRF or subject’s diaries with fictitious information; violating eligibility criteria in order to boost recruitment; etc.
Misconduct
Either intentional or unintentional failure to follow proper conduct.
Examples of misconduct warning signs: generation of false data due to carelessness, inexperience or misunderstanding, but with no intent to deceive; failure to follow the protocol; inexperienced site-staff; perceived unawareness of the Investigator’s Brochure (IB) or SmPC; too many studies at the same time at a site with the limited staff-capacity; disregard for participant safety and/or data integrity; lack of GxP knowledge in site personnel; inadequate or inaccurate record-keeping; etc.
Serious breach
Any deviation of the approved clinical trial protocol version or the Regulation (EU) No 536/2014 or local regulation that is likely to significantly affect safety, rights or wellbeing of clinical trial participants, and/or data reliability and robustness.
Examples of serious breach warning signs: a breach of regulation and/ or protocol that resulted in a serious adverse event (SAE); a systematic non-compliance with GCP or protocol resulting in significant impact on the integrity of the scientific value of studies; participant was dosed with the incorrect IMP from a different clinical trial; safety evaluation required by the protocol were consistently not performed; the investigator would not allow sponsor access to the trial participants’ notes; loss of data; participants incorrectly randomised; etc.
COMMUNICATE
If you are suspicious of fraud, misconduct or serious breach: inform the sponsor within 24 hours of detecting the issue by sending an email to sb@zentiva.com.
The report should contain at least:
- data of incident
- description of incident
- supporting evidence
The sponsor may arrange a meeting to discuss it. Please stay available in case the sponsor has any follow-up questions.
In case of a suspected serious breach, please complete the form
- Reporting form of suspected serious breaches | DOCX file, 51 KBDownload
Information for our suppliers
Effective August 30th, 2024, the current email address zentiva"country code"docs@eportaldoc.com (e.g., zentivaUKdocs@eportaldoc.com) will no longer be used for invoice submissions because of changes of e-mail domains. The new email address format is "Country code"docs@Zentiva.com (e.g., UKdocs@Zentiva.com).