Regulatory Guidance:
Within a year of completing a clinical trial the Sponsor needs to provide a completed study report (CSR) to the regulatory agencies who approved the trial.
According to ICH E3 guidelines “Structure and Content of CSR” there should be brief narratives describing each death, each other serious adverse event, and those of the other significant adverse events that are judged to be of special interest because of clinical importance. These narratives can be placed either in the text of the report or in section 14.3.3, depending on their number.
Events that were clearly unrelated to the test drug/investigational product may be omitted or described very briefly.
In general, the narrative should describe the following: the nature and intensity of event, the clinical course leading up to event, with an indication of timing relevant to test drug/investigational product administration relevant laboratory measurements, whether the drug was stopped, and when; countermeasures; post mortem findings; investigator’s opinion on causality, and sponsor’s opinion on causality, if appropriate.
In addition, the following information should be included:
- Patient identifier
- Age and sex of patient; general clinical condition of patient, if appropriate
- Disease being treated (if the same for all patients this is not required) with duration (of current episode) of illness
- Relevant concomitant/previous illnesses with details of occurrence/ duration
- Relevant concomitant/previous medication with details of dosage
- Test drug/investigational product administered, drug dose, if this varied among patients, and length of time administered
Why is Pharmora the strategic partner of choice for CSR Safety Narratives?
The Pharmora Medical Department is led by our Chief Medical Officer, Dr Jones, an experienced pharmaceutical physician with patient safety and clinical development background. Dr Jones worked in large global pharmaceutical companies and small biotechnology companies prior to founding Pharmora, in addition to maintaining a role as a GP, and has qualified as an educational supervisor. Dr Jones has trained the narratives teams to consider all the factors of relevance to the triggering events, including potential alternative causes, and ensure the full context for the event is clear for the reviewer. We therefore not only understand the regulatory background to these important documents, but also the importance of providing the full medical context for each of the triggering events.
Pharmora also understands the challenges of writing these narratives and has a highly skilled team of medics and scientists ready to support our clients.
Read the next part to explore the challenges and find out why Pharmora is so good at providing narratives for our clients… Click here for Part 2
