Serious adverse events, serious adverse reactions and suspected unexpected serious adverse reactions arising from clinical trials in Perú must be notified by the sponsor to the General Office of Research and Technological Transfer (OGITT) of the National Institute of Health (INS), in accordance with the definitions and time frames specified in Clinical Trials regulations, D.S. 021-2017-SA (art. 110, subsection a).
All serious adverse events, serious adverse reactions and suspicions of serious and suspected unexpected serius adverse reactions, must be notified by the sponsor / OIC as soon as possible, within a maximum period of seven (7) calendar days, since the sponsor becomes aware of the fact, otherwise it would be an infraction of DS 021-2017-SA (article 131, subsection e).
Enter the data electronically, through the REAS-NET database, using the electronic format FOR-OGITT-046 (Click here using the username and password). After completing the electronic form, it must be printed and sent to the INS Document Processing Office.
It will complete, if necessary, the information of the initial report, within the following eight (8) calendar days, otherwise it will send follow-up reports. After the follow-up is completed, a final report will be sent. The blind will be open if appropriate.
The following should be taken into account:
- Fill the e-form with complete data, do not leave blank spaces, and follow a chronological order in the narrative. Use the correct term to name the SAE, look up the terms in the WHO Adverse Reaction Terminology Dictionary (WHO-ART) included in the system.
- In the event that the notifier identifies wrong information in the report of serious adverse events sent through REAS-NET, the change must be requested by sending a document justifiying the reasons, through the INS Document Processing Office.
- In exceptional cases in which it is necessary to request the cancellation of the report, a document must be sent justifying the reasons, through the INS Document Processing Office.
The principal investigator must notify the sponsor or CRO about the pregnancy of a woman under investigation or of the partner of the subject under investigation, as soon as possible within the terms established in the clinical trial regulations. The sponsor or CRO must report to OGITT / INS using the format FOR-OGITT-047 “Notification of the Pregnancy and the Newborn in Clinical Trials” (Click here) and send it in printed format and on CD through the INS Document Processing Office. This format can not be accessed through the virtual system.
Suspected Unexpected Serious Adverse Reactions (SUSAR)
The SUSARs and Serious adverse reactions that occur internationally must be notified by the sponsor or CRO to OGITT / INS, quarterly or semiannually, as appropriate. DS 021-2017-SA (article 110, subsection c). These reports in CIOMS format, must be sent on a CD that will also include a Summary List of the reports, in an Excel file and in Spanish, with a cover letter through the INS Document Processing Office. These reports should not be translated or presented in printed format and can not be sent through the virtual system.
The information that should be included in the Summary List of SUSAR reports can be found in the Safety Reports Guideline (Click here).
Any finding that could adversely affect the safety of the research subjects, have an impact on the conduct of the study or alter the benefit / risk balance, should be reported through an expedited safety report. It can be any event that threatens the safety of the participants in the study and / or alters the benefit / risk balance. A report will be prepared independently and sent to the INS and the IRB involve, as son as posible, within a maximum period of seven (7) calendar days. DS 021-2017-SA (article 108, subsection h).