Current directives and regulations for clinical trials entailing investigational medicinal products (IMP) and medical devices set high standards for safety reporting compliance. The regulations and national requirements may vary according to the type of product/device under investigation and country of clinical conduct.
The Safety Officers of CTC’s Pharmacovigilance department offer in-house advice and establish necessary safety reporting processes applicable for your study. The Safety Officers carry out their work in close collaboration with the Medical Monitor and the Safety Physician and have the key function of coordinating activities related to safety reporting.
The services may include first-time registration of your organisation in EudraVigilance, the European Medicines Agency’s database for reporting Suspected Unexpected Serious Adverse Reactions (SUSARs), which is mandatory for IMP studies conducted within EU/EEA.
Moreover, our Safety Officers manage overall responsibility for surveillance of any incoming serious adverse events (SAEs) or device deficiencies, assess validity, establish required documentation as well as report to the local competent authorities according to applicable regulations and directives.
As part of the SAE management, our Safety Physicians are responsible for performing the medical review and assessment of incoming SAEs and device deficiencies with regards to causality and expectedness that is required by the authorities.
- Establish a safety management plan
- First-time EudraVigilance registration or updates of prior registration
- Submission of a medicinal product/substance for Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) which assigns a unique code to the entity, i.e. an EV Code
- SAE and device deficiency report surveillance, tracking and processing
- Medical review and assessment of causality and expectedness of incoming SAEs and device deficiencies performed by Safety Physicians
- Perform unblinding procedure for safety reasons or reporting purposes
- CIOMS I form preparation – This form provides an international standardised format for the reporting of suspected unexpected adverse reactions in ICH E2B (R2 and R3) format
- Write SAE case narratives
- Expedited SUSAR reporting to local authorities via EudraVigilance
- Establish line listings and summary safety reports of SUSARs
- SAE reconciliation to assure conformity between safety data
- Medical device safety reporting
Development Safety Update Report (DSUR)
During the clinical development of investigational drugs and biologicals, periodic analysis of safety information is crucial to the ongoing assessment of risk to trial subjects. It is a regulatory requirement for a sponsor of interventional clinical trials to annually inform the competent authorities and other interested parties, such as ethics committees, the results of such analyses and the evolving safety profile and appraise them of actions proposed or being taken to address safety concerns.
The comprehensive review of safety data and findings should be presented in the standardised format of a DSUR and, once a year at a predefined time-period, submitted to regulators as long as the clinical development program is ongoing.
CTC’s Pharmacovigilance department offer the full service of producing and submitting your DSUR according to established regulatory guidelines. The service entails establishing timelines for development, a full report written by CTC’s Medical Writers, medical review by a Medical Monitor and quality control of content and format.
- Establish timelines for DSUR
- Comprehensive summary of safety findings written by CTC’s Medical Writers in ICH E2F format
- Medical review by Medical Monitor
- Quality control
- Submission of DSUR to competent authorities and ethics committees