Safety Management Plan.
Full support for this critical trial safety document.

Why is a Safety Management Plan so important?

What is a Safety Management Plan?

During the developmental phase of a medicinal product, the Safety Management Plan (SMP) is a critical document for clinical trial sponsors to effectively mitigate risks for trial activities.

Its principal purpose is to serve as an operational blueprint, delineating the roles, responsibilities, processes, and timelines governing all stakeholders engaged in the safety of the clinical trial.

The SMP defines all communications pertaining to clinical safety among the Sponsor, CRO/PV Service providers, Safety Database provider, and other relevant parties.


SAEs, SUSARs & reporting.

The SMP explicitly outlines the responsibilities of each entity throughout the trial including, specifying procedures for narrative composition, triage and reportability assessments, unblinding processes, and most significantly, the management of Serious Adverse Events (SAEs), particularly Suspected Unexpected Serious Adverse Reactions (SUSARs), necessitating expedited reporting.

In many cases, initial reports necessitate subsequent inquiries with clinical trial investigators to gather additional information or clarify details about the reported incidents.

These inquiries often involve determining causality, which can impact whether an event warrants expedited reporting. The SMP plays a pivotal role in streamlining and standardizing these follow-up reports into coherent event narratives and updating previously submitted information.

Given the multifaceted nature of clinical trials involving various stakeholders, such as Sponsors, CROs, safety vendors, etc., a precise description of the flow of SAEs and SUSARs is imperative, including designating the initial recipient of safety reports on behalf of the Sponsor and defining the documentation processes, which relate to the commencement of the reporting deadline from ‘Day Zero’.


Process, people & details.

The SMP must provide comprehensive details on the steps involved in processing SAEs/SUSARs, encompassing narrative composition, medical reviews, triage, reportability assessments, unblinding procedures, reporting mechanisms to national and central authorities (e.g., EudraVigilance), and dissemination to investigators.

It should meticulously specify the responsible parties for each step and the interactions between these stakeholders throughout the process.

Furthermore, the SMP should compile a roster of accountable individuals, backups, communication channels, documentation prerequisites, and timelines for executing each of those steps. It may also extend or potentially supersede the existing Standard Operating Procedures (SOPs) of the Sponsor, CRO, or safety vendor.

All safety-related training associated with a clinical trial should be anchored in the SMP’s content, including training for Clinical Research Associates (CRAs), Medical Monitors, and other members of the Sponsor or CRO.

Click for information from EMA on clinical reporting.

Why use Aeigisana’s SMP services?

Detail oriented.

A well-crafted, articulate, and comprehensive Safety Management Plan (SMP) holds the potential to yield substantial benefits. It enhances efficiency, minimizes the likelihood of compliance lapses, and ensures that all stakeholders involved in a clinical trial uphold their safety obligations.

The design and substance of the SMP play a central role in shaping the execution of drug safety activities within a clinical trial.

Confidence through expertise.

Our clinical safety team is adept at providing the expertise needed to either strengthen existing SMPs or develop entirely new ones that are transparent, all-encompassing, and detailed.

We aim to create lasting, strategic partnership with sponsors across their clinical development programs based on efficiency, communication and service delivery.

In addition to SMPs, we offer a spectrum of Clinical Safety Services trial to support your needs throughout the clinical trial process, and facilitate the seamless and compliant execution of clinical trial drug safety measures.