Essay Example on How does a CRA contribute to monitoring safety on a clinical trial









How does a CRA contribute to monitoring safety on a clinical trial Being a CRA has to do with lots of responsibility even evident from the basic definition of our role as we are responsible for ensuring that the clinical trial we are assigned with is conducted in accordance with the applicable ICH GCP Regulatory and protocol requirements The most important core of this role is making sure that subject safety comes first and is safeguarded at all times within and outside protocol guidelines as this is the main purpose of the ICH GCP Guidelines This mandates thorough knowledge of the ICH GCP and GMP principles along with constant training on the updates of the EU and country specific regulatory context in conjunction with protocol requirements and EU Directives Directive 2001 20 EC and CFR21 Principles Monitoring safety basically involves full awareness on 2 sides of the coin figure 1 One is protocol specific and is defined within documents such as the safety and medical management plans clinical monitoring plans deviation guidance document protocol IB AE SAE Reporting guidelines and the other is protocol independent and is based on ICH GCP principles and EU and global timely reporting requirements of safety events with all required information and immediate action undertaken as mandated per timelines to safeguard subject safety and of course follow protocol s and medical monitoring team s instructions Figure 1 Monitoring safety is a two sided coin Even at the initial stage of the study site participation CRA needs to ensure document and even follow up on the below The PI and all study team are very well aware of ICH GCP Principles and recent addendums 

The PI is experienced and is aware of the general timelines of SAE AE reporting and of the proper documentation of the severity and causality and also of his obligations with respect to IP handling and administration as per GMP guidelines The PI is aware of ICH GCP Regulatory and protocol requirements Further to the above CRA s responsibility is to also identify and escalate site s training needs in order to ensure subject safety and protocol compliance As a CRA prior to IMVs SAE listings need to be run and used filtered by site Timely reporting to Sponsor needs to be ensured and of course safety event needs to be verified against source documentation hospitalization records if any relation to IP action taken with respect to IP if needed CRA needs to ensure all information is present in source accurate and detailed as per ALCOA principles with clear causality and with immediate action taken as per protocol instructions and MM s recommendations if applicable Cross check of the SAE Report also needs to be completed at first visit at site and verified against all available source documentation CRA also needs to ensure timely reporting to the authorities if expedited reporting is expected i e in site s LEC IRB and in MOH CRA s proactive review of laboratory reports is also preferable to ensure there are no abnormal concerning results that require re test 

IP discontinuation and immediate action in general with respect to safeguarding subject safety and ensure protocol compliance CRA should also ensure all abnormalities are discussed with the qualified Investigator CS marked and all abnormalities are documented and reported as AEs as required if CS is confirmed by Investigator sign off Awareness of the Safety and Medical Management Plan IPD Guidance document SAE SUSAR listings filtered per country site and reporting strategy and along with the Laboratory Manuals and protocol of course are prerequisite at all times to ensure all actions are taken if needed for subject safety CRA should also pay attention to all details listed in the ICF with respect to the expected AEs related to the IP and also with contraceptive requirements to make sure that Investigators are fully aware of expected AEs but also on the study s contraceptive requirements and that they are fully trained on the required discussion topics with subjects Moreover site needs to be fully trained on actions required in the event of pregnancy The information on the 24h emergency number of the Investigator in the site specific version of the ICF should also be confirmed by the CRA making sure that this number will always be available in case of subject emergency or urgent need for consultation on study requirements IP dosing etc outside clinic work hours 

At all times previous IMV Reports also need to be referenced for safety information and important deviations that were reported or required follow up in order to be source data verified against all updated safety information available at site Finally eligibility is a very important key aspect to subject safety that mandates careful review of inclusion exclusion criteria in conjunction with detailed review of prohibited medication and medical history to make sure subject is not receiving any prohibited medication or does not need any adjustments or cessation of his current medication that could jeopardize his health CRA also needs to ensure that the study s MM is consulted when needed and encourage site to timely liaise with the medical monitor in case of medical doubts or concerns The CRA should also ensure the Investigators are aware of the 24h emergency number where the medical Monitoring team can be advised in case of emergency

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