Is this relevant? (This is Canada)
***I would translate "señal en curso" as "ongoing signal".***
3.15 Overview of Signals: New, Ongoing, or Closed
The general location for presentation of information on signals and risks within the PBRER is shown in Appendix F of this Guideline. The purpose of Section 15 of the PBRER is to provide a high level overview of safety signals that were closed (i.e., the evaluation was completed) during the reporting interval as well as ongoing signals* that were undergoing evaluation, at the end of reporting interval. For the purposes of the PBRER, a signal should be included once it has undergone the initial screening or clarification step, and a determination made to conduct further evaluation by the MAH. It should be noted that a safety signal is not synonymous with a statistic of disproportionate reporting for a specific drug/event combination as a validation step is required. Signals may be qualitative (e.g., a pivotal individual safety case report, case series) or quantitative (e.g., a disproportionality score, findings of a clinical trial or epidemiological study). Signals may arise in the form of an information request or inquiry on a safety issue from a regulatory authority.
Decisions regarding the subsequent classification of these signals and the conclusions of the evaluation involve medical judgement and scientific interpretation of available data, which is presented in Section 16 of the PBRER.
A new signal is a signal that the MAH became aware of during the reporting interval. New clinically important information on a previously closed signal* that became available during the reporting period of the PBRER (i.e., a new aspect of a previously refuted signal or recognised risk likely to warrant further action to verify) would also constitute a new signal. New signals may be classified as closed or ongoing, depending on the status of signal evaluation at the DLP of the PBRER. Examples would include new information on a previously:
Closed and refuted signal, which would result in the signal being re-opened;
Identified risk which is indicative of a clinically significant difference in the severity of the risk, e.g., transient liver enzyme increases are identified risks and new information is received indicative of a more severe outcome such as hepatic failure; neutropenia is an identified risk and a well documented and unconfounded case report of agranulocytosis is received;
Identified risk for which a higher frequency of the risk is newly found, e.g., in a subpopulation; and
Potential risk* which, if confirmed, would warrant a new warning, precaution, a new contraindication or restriction in indication(s) or population or other risk minimisation activities.
Within this section, or as an appendix, include a tabular listing of all signals ongoing or closed at the DLP of the PBRER. This table should include the following information: See Appendix C for an example.
A brief description of the signal;
Date when the MAH became aware of the signal;
Status of the signal (closed or ongoing at the DLP);
Date when the signal was closed, if applicable;
Source of the signal;
A brief summary of key data;
Plans for further evaluation; and
Actions taken or planned.
Detailed signal evaluations for closed signals are not to be included in this section but instead should be presented in Section 16.2 of the PBRER (Signal Evaluation). Evaluation of new information in relation to any previously known identified and potential risks and not considered to constitute a newly identified signal* should be provided in Section 16.3 of the PBRER (Evaluation of Risks and New Information).
When a regulatory authority has requested that a specific topic (not considered a signal) be monitored and reported in a PBRER, the MAH should summarize the result of the analysis in PBRER Section 15 if it is negative. If the specific topic becomes a signal, include it instead in the signal tabulation and discuss in PBRER Section 16.2.
3.16 Signal and Risk Evaluation
The purpose of Section 16 of the PBRER is to provide:
A succinct summary of what is known about important identified and potential risks and important missing information* at the beginning of the reporting interval covered by the report (16.1);
An evaluation of all signals closed during the reporting interval (16.2);
An evaluation of new information with respect to previously recognised identified and potential risks (16.3);
An updated characterisation of important potential and identified risks ,where applicable (16.4); and
A summary of the effectiveness of risk minimisation activities in any country or region which may have utility in other countries or regions (16.5).
Appendix F of this Guideline provides a flowchart to illustrate the mapping of signals and risks to specific sections of the PBRER.
The evaluation subsections should not summarise or repeat information presented in previous sections of the PBRER, but should instead provide an interpretation of the information, with a view towards characterising the profile of those risks assessed as important. As a general rule, it is not necessary to include individual case narratives in the evaluation sections of the PBRER; however, when integral to the scientific analysis of a signal or risk, a clinical evaluation of pivotal or illustrative cases (e.g., the first case of suspected agranulocytosis with an active substance belonging to a class known to be associated with this adverse reaction) should be provided.