Standard operating procedure

Size: px

Start display at page:

Download "Standard operating procedure"

Beryl Banks
5 years ago
Views:

1 Standard operating procedure Title: Specific signal detection for situations including a pandemic Status: PUBLIC Document no.: SOP/H/3317 Lead author Approver Effective date: 28-OCT-10 Name: Xavier Kurz Name: Peter Arlett Review date: 28-OCT-13 Signature: ON FILE Signature: ON FILE Supersedes: N/A Date: 27-SEP-10 Date: 04-OCT-10 TrackWise record no.: Purpose There are a number of situations (e.g. an influenza pandemic) where signal detection and validation need to be performed more often (e.g. once a week) for all or for selected products and where the Rapporteur(s) need to be informed more frequently of an emerging safety issue that needs to be immediately assessed. This SOP describes the processes and timelines related to the weekly detection and validation of signals by the Signal Validation Team (SVT) using EudraVigilance data. The validation of signal leads to the immediate communication of information to Rapporteur(s). 2. Scope The SOP applies to the Pharmacovigilance and Risk Management Sector, in particular the Data Collection and Management (DCM) and Signal Detection and Data Analysis (SDA) sections. 3. Responsibilities The decision to initiate and terminate the procedure described in this SOP is taken by the Head of Signal Detection and Data Analysis Section in consultation with the Head of Sector of the Pharmacovigilance and Risk Management sector. The decision includes the start date of the procedure, the products to be specially monitored, the format of the Reaction Monitoring Report (if a specific format needs to be defined) and the nomination of the Signal Validation Team (SVT) member(s) involved in the Procedure. The DCM and SDA Section Heads in collaboration with the Signal Validation Team define the content and the format of the Reaction Monitoring Reports. 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0) Facsimile +44 (0) info@ema.europa.eu Website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 4. Changes since last revision New SOP. 5. Documents needed for this SOP SOP/H/ Periodic Signal Detection For Centrally Approved Products based on Reaction Monitoring Reports. WIN/H/ Screening Reaction Monitoring Reports for new Signals. WIN/H/ Searching and Printing CIOMS forms and Line Listings. WIN/H/ Validating and Reporting WIN/H/ Using EPITT for Signal Management by the Signal Validation Team. WIN/H/3300 Organisation of periodic signal validation meetings. WIN/H/3331 Production of the weekly Reaction Monitoring Report for Pandemic Vaccines in EVDAS 6. Related documents None. 7. Definitions CIOMS form: The CIOMS form is the form contained in the final report of the CIOMS I working group on International Reporting of Adverse drug reactions corresponding to the minimum standard of information contained in a CIOMS report. This form can be downloaded from the Council for International Organizations of Medical Sciences (CIOMS), website: and may be used to report a single ADR. Reaction Monitoring Report: is a summary report which provides an overview of the adverse reactions grouped by MedDRA System Organ Class (SOC) for specific active substances/medicinal products, including the number of cases grouped by EEA/non EEA cases and new/total number of cases. Signal: A signal is information on an adverse event that is new or incompletely documented, that may have causal relationship to treatment and is recognized as being worthy of further exploration. Signal Validation Team (SVT): includes the Head of Sector (HoS) P-PV, or his/her delegate, acting as Coordinator, some members of the P-PV Sector nominated by the HoS, the Signal Detection and Analysis Section secretary and other European Medicines Agency staff members as necessary who are responsible for performing signal detection of new safety signals related to Centrally Authorised products. Signal Detection and Data Analysis (SDA) secretary: provides secretarial support to SDA Section. SOP/H/3317, 28-OCT-10 Page 2/5

3 8. Process map(s)/ flow chart(s) START DAY 1 1. Send Reaction Monitoring Reports 2. Perform Signal identification DAY 2 No 3. Has a signal been identified? Yes 4. Retrieve CIOMS forms or Line listings 5. Review CIOMS forms or Line listings 6. Draft Signal 7. Circulate Signal 8. Update Tracking Table DAY 3 9. Discuss Signal during the Signal Validation meeting 10. Has a signal been validated? Yes 11. Enter Signal Description into EPITT No 10.1 Monitor or close the signal 12. Circulate draft Signal Description for internal consultation 13. Update Signal Description in EPITT DAY Send Signal Description 15. Update the Tracking Table END SOP/H/3317, 28-OCT-10 Page 3/5

4 9. Procedure Step Action Responsibility 1. Send Reaction Monitoring Reports DCM Member Open the RMRs which were sent to the H-SD mailbox on Day 1 (Tuesday) the week the meeting is taking place. The RMRs are generated according to WIN/H/3331 Production of the weekly Reaction Monitoring Report for Pandemic Vaccines in EVDAS. 2. Perform Signal identification As described in WIN/H/ Screening Reaction Monitoring Reports for new Signals. 3. Has a signal been identified? If No, go to the End If Yes, go to Retrieve CIOMS forms or Line listings As described in WIN/H/ Searching and Printing CIOMS forms and Line listings. 5. Review CIOMS forms or Line listings 6. Draft Signal 7. Circulate Signal 8. Update Tracking Table. As described in WIN/H/ Maintenance of the Signal Detection tracking table. 9. Discuss Signal during the Signal Validation meeting. 10. Has a signal been validated? SDA Secretary SVT member If No, go to 10.1 If Yes, go to Monitor or close the signal on the basis of the outcome of the Signal Validation meeting. SOP/H/3317, 28-OCT-10 Page 4/5

5 Step Action Responsibility Go to Enter Signal Description into EPITT As described in WIN/H/ Using EPITT for Signal Management by the Signal Validation Team 12. Circulate draft Signal Description for internal consultation 13. Update Signal Description in EPITT As described in WIN/H/ Using EPITT for Signal Management by the Signal Validation Team 14. Send Signal Description 15. Update the Tracking Table SDA Secretary As described in WIN/H/ Maintenance of the Signal Detection tracking table. 10. Records Signal Notifications sent by each reviewer of the Reaction Monitoring Reports are stored in electronic format in the mailbox Public Folders/Chrono In/ S/H-SD. All signals with the corresponding Reaction Monitoring Reports are listed in the Signal Detection Tracking Table. This table is named SDMDB-IM_RM 2.xls and is located in: documentum\docbases\edms\operational Units\Human\Post\PHVSE\H-Pharmacovigilance\Signal detection PhV and PASE\IM RM CAP list. All Reactions Monitoring Reports are stored in electronic format in a folder located in Reaction Monitoring Reports are saved in a folder called situation. It is located in: documentum\docbases\edms\products\pandemic Crisis Folder\10 Crisis\April 09 Mex US outbreak\phv\weekly Pandemic Pv Report\Month Year Signal s are stored in electronic format in: The mailbox Public Folders/Chrono In/ S/H-SD documentum\docbases\edms\operational Units\Human\Post\PHVSE\H-Pharmacovigilance\Signal detection PhV and PASE\2010\mm\dd Signal Descriptions are stored in the EPITT system. SOP/H/3317, 28-OCT-10 Page 5/5

EudraVigilance: are you ready for change?

EudraVigilance: are you ready for change? Pharmacovigilance Platform Nederland 26 September 2017 Anja van Haren 1 Content 1. Introduction 2. MAH obligation for signal detection on EV 3. ADR reports 4.