Adverse Event Reporting in Clinical research – a Joint Responsibility

Reporting adverse event of a drug is one of the most important aspects of conducting a clinical research. Clinical trials are conducted to know the safety, tolerability and efficacy of a new drug in human system, which in turn would decide whether that particular drug would receive marketing authorization in a particular region and if the drug receives marketing authorization what could be the potential side effects and risks associated with the usage of that medicine. Different adverse events caused by a drug/medicinal product have to be properly collected in time and should be reported to the corresponding regulatory authority. As many stakeholders are involved in a clinical trial process, reporting adverse events thus become a joint responsibility of all the involved parties.Depending on the seriousness, every adverse event has to be reported within particular time period. Any delay in the reporting of the adverse event would be considered as punishable for the sponsor company who is conducting the trial. Thus adverse event reporting would be a joint responsibility for the sponsor (the Biopharma company, Govt. agency or a particular physician who is conducting the trial), investigator (the doctor who is conducting the clinical trial at site) and the monitor (who would work as sponsor’s representative and monitor the trial conducted at sites).

Sponsor responsibility

The sponsor should expedite to all concerned investigator(s) working at different institutions(s), to the IRB/IEC where required, and to the regulatory authority (ies) of all adverse drug reactions (ADRs) recorded during clinical trials that are both serious and unexpected. Such expedited reports should comply with the applicable regulatory requirement(s) and with the ICH Guideline for Clinical Safety Data Management. The sponsor should submit to the regulatory authority(ies) all safety updates and periodic reports, as required by applicable regulatory requirement(s). The sponsor should monitor if the clinical trials has been conducted in compliance to the protocol, GCP guidelines and applicable regulatory requirements by proper monitoring processes at regular intervals.

Monitor responsibility

Monitors are one of the important stakeholders recruited by the Sponsor/CRO. The primary responsibility of a monitor is to check whether the rights and well-being of human subjects are protected during the conduct of the clinical trial. He/she would also check if the reported trial data are accurate, complete, and could be verified from source documents. Monitor has to check if the site team is conducting the trial in compliance with the approved protocol, GCP, and the applicable regulatory requirement(s).

The monitor should check if the study has been conducted in site properly, by directly visiting the trial sites, through continuous review of the records. Apart from direct visits the monitor should communicate with the site through telephone, fax or email in the interim period. Specific reports and data collected at site which may be indicative of an unreported adverse event should be promptly instructed to the investigator to report. This includes addition of concomitant medications at any visit, assessment of symptoms reported by the subject, subject diaries and all medical record entries collected after the initial study visit date and prior to the study end date.

Another major responsibility of monitor would be to evaluate all reported adverse events to assess the need for obtaining a follow-up report from the investigator. Cases where follow up report might be required include, (i) a serious adverse event for which complete information was not available from the initial report, (ii) previously reported adverse event, for which any new information becomes available, (iii) finding a resolution of a previously reported unresolved adverse event, (iv) early termination of a subject for whom an unresolved event was reported, (v) study completion by a subject for whom an unresolved event was report.

The monitor is the first line of communication between the sponsor and investigator throughout the study.One of the most critical functions of the monitor is to assure that investigators are fully aware of working  in compliance to responsibilities of  immediate reporting the adverse events to the sponsor and the IRB ( Institution Review Board) .To achieve this, the monitor must teach the adverse event reporting requirements to investigators properly and whenever required help them in future. Thus, the monitor must be knowledgeable about the regulatory and sponsor-specific requirements for reporting serious and non serious adverse events in clinical trials.

Investigator responsibility

The investigator would be conducting the clinical trial at site. The investigator would lead the team working at site, would conduct the research and provide treatment to the subjects and collect their data. All serious adverse events (SAEs) collected by the investigator should be reported immediately to the sponsor except for those SAEs which according to the protocol or other document (e.g., Investigator's Brochure) identified as not requiring immediate reporting. The investigator has to send the immediate report of any serious adverse event to the sponsor by phone, email, fax within 24 hrs. A detailed written report of the event should follow within the next 48 hrs for most of the cases. The immediate and follow-up reports should identify subjects by unique subjects identification number assigned to the trial subjects.The investigator also has to report unexpected serious adverse drug reactions to the regulatory authority (ies) and to the IRB/IEC in compliance to the applicable requirement(s). Adverse events along with abnormal laboratory findings (specially mentioned in the protocol as critical for safety evaluations) should be reported to the sponsor according to the reporting requirements and within time periods specified in the protocol. For reporting of fatal outcome (death), the investigator should submit an additional requested information (e.g., autopsy reports and terminal medical reports) to the sponsor and the IRB/IEC with any additional requested information (e.g., autopsy reports and terminal medical reports).

Thus proper reporting, monitoring of the AE reporting and successful coordination between the different stakeholders finally results in successful reporting of AE data which in turn helps to collect all the side effect, adverse effect of the drug and help in the development of  drugs with more efficacy and less side effects.

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