National Control Department Safety Sub-department Clinical Trials Section [Illegible]

Transcription

1 National Control Department Safety Sub-department Clinical Trials Section [Illegible] CIRCULAR No 05/10 RE: Clarifies and Completes Circular No 4/09 concerning Notification of Adverse Events in Clinical Trials Santiago - MAY 4, 2010 The Management of this Institute has deemed it necessary to complete and clarify paragraph 2.3 of Circular No. 4 dated Sep/05/2009. This document is intended for all professionals involved in one way or another in the conduct of human clinical trials to show the safety, quality and efficacy of an investigational medication and is intended to establish the fundamentals to be applied for the reporting of Adverse Events in Clinical Trials at this Institute. 1.- The Sponsor or CRO (when the sponsor has made a delegation of responsibilities to the CRO) must report to the National Center for Drug Information and Pharmacovigilance (CENIMEF), ALL study drug-related adverse events, in the manner described below: The sponsor or CRO must notify CENIMEF of related serious adverse events within a period of 15 working days from the time the sponsor or CRO becomes aware of them. Both the anticipated and the unanticipated national related serious adverse events must be reported, in full format on the usual forms (CIOMS, MEDWATCH, etc), or on the suspect ADR reporting form available on the website of the ISP. Only the unanticipated international related serious adverse events must be reported, in summary format, which can be designed by each sponsor or CROs, and must contain the minimum information necessary for case identification and follow-up, in the possible case of needing full information on the event The related NON-SERIOUS (national and international) adverse events will be reported in the safety report, which must be sent by the sponsor or CRO to CENIMEF at a frequency determined by the duration of the study: 1

2 For studies of up to one year in duration, reports should be delivered at the middle and at the end of the study. For studies of between one and two years duration, the Report must be delivered every six months and at the end of the study. For studies of more than two years duration, the Report must be delivered annually and at the end of the study The reports can be sent via to the address: in English or Spanish. 2.- A glossary of terms is listed below in order to standardize the concepts included in this circular: Contract Research Organization (CRO): A person or organization (commercial, academic or other) contracted by the sponsor to perform one or more of the sponsor s study-related tasks and functions. Adverse Event: Any incident harmful to the health of a clinical trial patient or subject treated with a drug, even though it may not necessarily have a causal relationship to this treatment. Related Adverse Event or Adverse Drug Reaction (ADR): In clinical experience prior to the approval of a new medicinal product or a new indication, particularly when the therapeutic dose cannot be established: all responses to a drug that are harmful and unintended, related to any dose, should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., that the relationship cannot be ruled out. Serious (Severe) Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR): Any adverse event or adverse reaction that, at any dose, results in death, is lifethreatening to the subject, requires hospitalization or its prolongation, results in permanent or significant disability or incapacity, or gives rise to a congenital anomaly or malformation. Cases that, while not being fatal or life-threatening, endanger the patient or may require intervention to prevent any of the results described above, should be assessed with scientific and medical criteria, since these should also be considered as serious or severe adverse reactions. 2

3 Periodic Safety Report: Safety assessment of the investigational medication taking into account all available information. Anticipated Adverse Reaction: Reaction described in the investigator's brochure. Unanticipated Adverse Reaction: Adverse reaction, the nature or severity of which does not match the information concerning the product (e.g., the investigator's brochure in the case of an investigational drug not approved for marketing or the product information sheet in the case of an approved drug). Severity of Adverse Event or Reaction: Mild: Adverse event that is well-tolerated by the subject, causes minimal discomfort and does not interfere with daily activities. Moderate: Adverse event that is sufficiently troublesome to interfere with the normal performance of everyday activities. Severe: Adverse event that prevents the performance of everyday activities. The terms serious and severe are not synonymous; the term severe describes the intensity of a specific event, for example, a headache may be severe, even though it is not serious. 3.- This Circular shall take effect from the date of its publication in the Official Gazette and shall apply to all clinical trials that are under way, and the Sponsors/CROs must report the adverse events that occur as from that date in the form described in points 1.1 and 1.2 TO BE RECORDED, COMMUNICATED AND PUBLISHED IN THE OFFICIAL GAZETTE. [SEAL] MINISTRY OF HEALTH DIRECTOR INSTITUTE OF PUBLIC HEALTH OF CHILE [SIGNATURE] DR. INGRID HEITMANN GHIGLIOTTO DIRECTOR INSTITUTE OF PUBLIC HEALTH OF CHILE DISTRIBUTION: Undersecretary of Public Health MINSAL [Health Ministry] Scientific Ethics Committees of the National Health Services Regional Ministerial Health Secretaries Health Service Departments Pharmaceutical Company Managers Technical Directors of Pharmaceutical Establishments 3

4 College of Pharmaceutical Chemists. Chilean College of Medicine. Chamber of the Pharmaceutical Industry. ASILFA [Industrial Association of Pharmaceutical Laboratories] UCIREN [Certification, Renewal and Hospitalization Unit] UNFACH [Pharmacy Owners Union of Chile] AFFI [Association of Pharmacists of Independent Pharmacies] Management of the Public Health Institute of Chile Legal Counsel National Control Dept. Safety Sub-dept. Records Sub-dept. CRO or firms carrying out clinical trials in Chile: o AstraZeneca de Chile. o Akron Clinical LLC. o Assing Inv. Clínica Suramérica o Activa 8 o Bayer S.A. o Brain Consultores o Bristol-Myers Squibb o CMS Medical Chile o Covance Chile Ltda. o Discovery Labs. o Dr. Mix CRO Ltda. o Foundation Chile o Fundación ESPRIT o Galderma Chile o Grunenthal GmbH Research and Development o GlaxoSmithKIine Chile Farmacéutica Ltda. o Genexion Chile o Genzyme Chile Ltda. o Gustavo Kaltwasser y Cia. Ltda. o 3 Latin América o ICÓN Chile S.A. o Intrials Chile o INC Research, INC Chile Ltda. o Kendle Chile Ltda. o Laboratorio Biosano o MDS Pharma Services o Medpace Chile Ltda. o Merck S.A o MS&Dohme o Novartis Chile o Omnicare Clinical o Organon o Pharma Investi Chile S.A. o Pharmaceutical Research Associates Chile SpA o Parexel International o Pfizer Chile o PPD International Holdings Inc y Cia Ltda o Proteus S.A. o PSI CRO AG o Quintiles Chile o Laboratorios Recalcine o Roche 4

5 o Sanofi Aventis Chile o Laboratorios Saval o Schering-Plough Cia Ltda. o Tecnofarma o Volta S.A. o Wyeth Inc. Reception Office Clinical Trials Archives Final version