The following safety information must be communicated to regulatory bodies.

Expedited Safety Reporting: Most of the regulations that describe safety reporting from clinical trials focus on the expedited reporting of individual case safety reports (ICSRs). The sponsors should submit suspected adverse drug reactions that are both serious and unexpected to regulators within 7 (if fatal or life-threatening) or 15 calendar days in an appropriate format.

Annual Safety Reporting: Most of the authorities accept Development Safety Update Report (DSUR) as outlined in the ICH E2F Guidelines along with regional specific appendix like in the U.S., the FDA IND regulations define an “annual IND report” which includes line listings of the most serious and the most frequent adverse events as well as reasons for discontinuation.

Urgent safety measures: Measures taken to protect clinical trial subjects due to an unexpected event that is likely to seriously affect the benefit-risk balance of the clinical trial.

The frequent review of serious and special interest adverse events, as well as overall assessment of all AEs, regardless of seriousness, causality, or expectedness, should be performed periodically:
> Ad hoc, for serious and special interest AEs,
> Routine, periodic, general review of all data, whose frequency will vary from trial to trial and from development program to development program and depend on many factors, and
> Reviews triggered by specific milestones established for a trial or a program (e.g., numbers of completed patients, end-of-trial, end-of-program, preparation of integrated summary of safety, and a marketing application).

Appropriate analyses should also be conducted periodically for safety-related information other than AEs, including physical examination findings, vital signs, clinical laboratory tests, cardiac electrophysiology, and other evaluations.

Aggregate safety data should be monitored and evaluated periodically during the course of the overall developmental program, during each study, and at the end of every study to provide an ongoing appraisal of benefit- risk balance.

Each time a study is completed and unblinded, all safety information, not limited to clinical AEs but ideally including emerging efficacy endpoints, vital signs, and clinical investigation results, should be assessed and evaluated relative to previous knowledge; product information should be updated as needed (investigator brochure, development core safety information, informed consent, company core safety information, local datasheets).

Module 2.3 Quality overall summary
Module 2.4 Non-clinical overview
Module 2.5 Clinical overview
Module 2.6 Non-clinical written and tabulated summaries
Module 2.7 Clinical summary
Module 3 Quality
Module 4 Non-clinical study reports
Module 5 Clinical Study reports

The way in which dissemination via the website occurs should be agreed with the competent authority of the Member State, i.e. as primary or as an additional way for dissemination.

The website address should be given to the competent authority of the Member State.

A statement that the information of the website is consistent with the educational material approved by the competent authority should be submitted to the competent authority of the Member State.

The specific website should not include any reference to documents or to other websites/pages or weblinks not agreed with the competent authority of the Member State.

All elements and information on the specific website should be expressed in the official language(s) as required by the Member State or, in exceptional cases with the agreement of the competent authority of the Member State, in English.

The specific website should not contain references to or information about medicinal products not marketed in that Member State.

Other relevant documents such as the SmPC, the PL and the summary of the RMP may be referred to.