The procedural steps of adverse events reporting are clear when it comes to clinical trials. But how about when patient interviews are conjoined to a trial? When and how to report when a patient mentions adverse events during a clinical trial interview?
At Clinigma® we are committed to patient safety just as highly as we are to explore the patients’ experiences with new investigational drugs. In compliance with our recently achieved ISO 9001 certification, Clinigma® has established processes for training of staff and reporting procedures. Using our specialized Clinigma® Portal, our company offers a unique possibility to ensure high compliance with existing safety reporting requirements.
Adverse events from patient interviews must be reported in due time regardless of whether they are market research or clinical trial-related. This requires a strong engagement with the pharma companies when it comes to determining the final process for adverse event reporting in or outside of a clinical trial:
- Adverse event reporting in clinical trials
Often the AE reporting process follows the requirements from the main clinical trial. However, a pharma company and the global pharmacovigilance team may often request a more tailored process when it comes to reporting adverse events from interim and exit interviews.
- Adverse event reporting in market research projects (outside of clinical trials)
AE reporting processes from market research interviews follow EphMRA´s guidance document. Although the safety data that is being reported are much the same (AE´s and SAE´s), the process can differ from trial patient interviews regarding timing and who to report to (investigator or sponsor).
At Clinigma® we are proud of our portal, which allows us to share possible (serious) adverse events directly and securely with the clinical sites and document the actions taken to ensure the safety of the patients. Our ability to document the actions and how they are followed is also important in the case of GCP inspections and/or audits.
At Clinigma®, we use our years of expertise in interviewing clinical trial patients and dedicated portal to support pharmaceutical companies in obtaining easy and direct patient feedback – while ensuring the safety of the patient.
Do you want to know more about how to interview the patients in your clinical trials in a way that is protecting the patients? Please click here to visit our website.