ALL BY
NEW COUNTRY
PAZ E Ç UI DA D E D UC A C I Ó N
EXTERNAL CIRCULAR
FROM TO:
DIRECTION OF MEDICINES AND BIOLOGICAL PRODUCTS
CONTRACT SPONSORS / RESEARCH ORGANIZATIONS RESPONSIBLE FOR THE REPORT OF
NATIONAL SERIOUS ADVERSE EVENTS ASSOCIATED WITH DRUG SAFETY IN
INVESTIGATION WITH HUMAN BEINGS
SUBJECT: REPORT OF NATIONAL SERIOUS ADVERSE EVENTS
DATE: February 18, 2016
In order to advance in the optimization of procedures related to clinical research protocols before the
group of Good Clinical Practices of the Directorate of Medicines and Biological Products; considering the
volume of information submitted with the individual report of adverse events in clinical investigation, and
taking into account the "Zero paper" policy, as well as Law 1437 of 2011, art 53 et seq and Directive No. 4 of
2012; the entity offers the possibility of filing information related to adverse events in
clinical research, through the format provided on the web, which can be accessed from the browser
Google Chrome using the link you will find in the FORMAT DILIGENCIATION GUIDE
REPORT OF ADVERSE EVENTS IN INVESTIGATION PROTOCOLS, arranged in the
INVIMA website through the Good Clinical Practices site.
For the maintenance of confidentiality and information security, each of the reporters is asked to
has assigned a personal and non-transferable password, which must be registered at the end of the loading of
information in the format of each of the reported serious national adverse events.
To obtain this key, you must do it through a personal presentation at the Medicines Department
and Biological Products, with the professionals of the Group of Good Clinical Practices, at the Chapinero headquarters
INVIMA.
Attent nt
LU FRANCO CHAPARRO
Dir to of Medicines and Biological Products.
Projected: 1. Ordoñez VoBo Legal: JP. Santaella. Archive: Circulars
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