Regulations

National regulations vary considerably in their requirements for reporting of adverse events. For serious events, however, accelerated reporting is required.

National regulations may require the sponsor and/or the investigator to report certain types of adverse events or reactions (e.g. serious, previously unknown) to the drug regulatory authority and the ethics committee. If required, all such reports should be accompanied by an assessment of causality and possible impact on the trial and on the future use of the product. In reporting, measures should be taken to avoid unnecessary duplication.

The investigator

The investigator has to report serious adverse events to the sponsor immediately and to the drug regulatory authority and the ethics committee as specified in the protocol and in accordance with national regulations. Normally, adverse events associated with the use of the product must be reported to the drug regulatory authority within a specified time limit.

Reports on adverse events submitted by the investigator to the drug regulatory authority should contain both subject and trial identification data (i.e. the unique code number assigned to each subject in the trial).

When reporting adverse events to the sponsor, the investigator should protect confidentiality by excluding the names of individual subjects, personal identification numbers (e.g. social security numbers) or addresses. The unique code number assigned to the trial subject should be used in the report and the investigator should retain the code to facilitate data verification by the sponsor or drug regulatory authority and any medical follow-up which may be warranted. The name of the investigator reporting the adverse events should be stated.

After the trial has been completed or terminated, all recorded adverse events should be listed, evaluated and discussed in the final report.

The sponsor

During the trial, the sponsor is responsible for reporting and trial-related adverse events or reactions associated with the use of the investigational product to the local health authority as required by national regulations and to other investigators involved in clinical trials of the same product.

The sponsor should also report as soon as possible to the investigator as well as to the drug regulatory authority and relevant authorities in other countries any trial with the same product that has been stopped due to action taken by a regulatory authority, or any other withdrawals of the product from the market for safety reasons. The sponsor should amend the investigator’s brochure as required to keep the description of adverse events updated and to include any other significant new safety information.