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Case processing (SAEs)
The data generated from clinical trials tends to be more complete than that received through typical channels of spontaneous reporting. Likewise the steps for follow-up are often far easier to take. Nonetheless, you will need to demonstrate consistently that your reporting process is adequately specified and resourced to the task.
Why Choose Prime Vigilance For Your Clinical Trial Case Processing?
PrimeVigilance consultants bring a wealth of experience to the interpretation of case reports within the necessary pharmacovigilance legal frameworks. Their expertise means your submissions to regulators are always compliant and on time. The following outlines just some of the reasons why companies choose our staff:
Expedited Reporting Timelines
Serious adverse events (SAEs) must be reported to the regulatory authorities within very strict time deadlines. During any pre-marketing trial, the onus is on your company for the investigator to explicitly specify which events are deemed serious and unexpected within your reporting. Your investigator must also make you aware of specific types of non-serious adverse events or laboratory findings. And all pre-marketing Suspected Unexpected Serious Adverse Reactions (SUSARS) must be reported to regulators within 7 days if they are classified as fatal or life-threatening. Those which are non-fatal, non-life-threatening or occurring during the post marketing phase must be reported within 15 days.
Defining Serious and Non-Serious Adverse Events
Expedited reporting requirements mean your standard operating protocols (SOPs) must involve the accurate grading of incidents within a suitable timescale. Our staff have the experience to advise on the grading process to ensure accurate and timely compliance. Their input is also crucial when it comes to demonstrating your analysis of risk-benefit ratios.
Appropriate Formats For Double Blind Trials
Since the standard for clinical trials is to work to a double-blind protocol, your team will need to understand how to appropriately un-blind the trial before engaging in expedited reporting. It is also vital that the correct personnel undertake this task to prevent jeopardising the integrity of the trial and/or presenting non-compliant data to the authorities.
Completing Your Causality Assessments
You will also need to demonstrate completion of an adequate causality assessment when completing your case processing for pre-marketing trials. Expert advice should be sought to determine whether this is also an expedient practice during your particular post-marketing trial.
Demonstrating Your Ceaseless Commitment To Clinical Trial Safety
As your trial progresses, you will need to demonstrate the continual evaluation of risk-benefit balance, enabling you to determine whether or not to allow the trial to continue. Where companies have outsourced part or all of the tasks associated with the trial, for example to a 3rd party Contract Research Organisation (CRO), the responsibility for correct Case Processing for SAEs still lies with the company as far as the regulations are concerned. Suitable SDEAs (Safety Data Exchange Agreements) must be in place and must have been agreed and established accordingly.
Formatting Your Reporting & Documentation
You will need to keep detailed records which can be reviewed on request by regulators during inspections For other purposes such as: the marketing authorisation application itself, product Pharmacovigilance Master System File (PMSF), etc. your staff will need to have been trained and kept up to date on EudraVigilance terminology to use in all reporting and comprehensive SOPs must be in place to cover these operations.
Non-compliance can result in costly remedial processes to complete tasks that should have been completed correctly in the first instance. It can even pose risks to the product’s ability to reach or stay on the market due to simply having presented data in a way which does not meet the regulations. To find out more about our clinical trial safety services, call us today in complete confidence on +44 (0)1483 307920. Our support is provided by consultants who have assisted on regulatory authorities; those who have worked for years within the pharmaceutical industry and now help companies navigate the complex waters of pharmacovigilance laws.
PrimeVigilance – Compliant and Consolidated
– just one of the pharmacovigilance services from PrimeVigilance
Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’). 2011/C 172/01)