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Clinical trials

National Agency for Medicines and Medical Devices (ANMDM) approved in April 2014 new regulations for (re) approval of establishments that can conduct clinical trials on medicinal products for human use (Decision no. 2/22.04.2014 issued by the National Agency Medicines and Medical Devices and Annexes). According to legislative changes, any medical facility (medical center, SCM, hospital, etc.) who intend to (re) allow for clinical trials of therapeutic benefit is required to hold their own standard operating procedures (Annexes 2 list minimum standard operating procedures) or be certified to implement a quality management system according to ISO standards in force trials (Annexes to Decision dated in April 2014 on approval of Regulations for the approval of establishments that can conduct clinical trials in medicines for human use - art. 5 (2) d). If your medical center is not ISO certification, becomes mandatory after 1 year from the entry into force of the to the said regulations.

In this regard, Mondor Management supports you, offering advice in developing their own standard operating procedures (Anexes 2 minimum list of standard operating procedures), mandatory for running clinical trials. These are:

  • procedure on the stages of a clinical trial;

  • procedure for recruitment and identification of subjects;

  • procedure for obtaining informed consent of the subjects;

  • procedures for source documents and their minimum content of information;

  • procedure for assessment and reporting of serious adverse events;

  • procedure for writing procedures;

  • procedure for organization of the team of investigators and delegation of responsibilities within a clinical trial;

  • procedure for study medication - reception, storage and management;

  • procedure for archiving documents.

Mondor Management will support for the certification. National Agency for Medicines and Medical Devices has decided that any medical center to be certified ISO until 22 April 2015. Our company offers consultancy for ISO certification. You can find more details on our website at section Quality Management and Stages of Consultancy.


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Copyright © 2009 SC Mondor Management SRL
Ultima actualizare: 30-12-2014
Data publicării: 23.01.2009