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IRB/IEC Audits
IRB/IEC Audits
IRB/IECs is the consortium constituted to review and monitor the biomedical research involving human subjects. IRB/IEC consortium plays an important role in protecting and safe guard the rights and welfare of the human participants in the biomedical research. IRB/IEC review mechanism and approval is a preliminary step to kick start the clinical trial. SO, it is very important to audit the IRB/IEC against the qualification before start of the trial, surveillance audits periodically and project specific audits on trial basis
We have expert team comprised of IRB/IEC real time experience to assess the IRB/IEC functions, process for review of protocols, approval process, honorarium, periodical change of quorum, opinion and involvement of subject matter experts, conflict of declaration, voting process, entry and exit policies, handling of AE/SAEs and reporting to regulatory authority, communication with the CDSCO, CRO, application of ICH GCP standards, implementation of internal SOPs, handling volunteer or subject complaints, audit history, Retention of records
Our team has thorough knowledge and expertise on various ethical aspects human populations involving in clinical trial which includes ICH GCP, WHO GCP, NDCT 2019 CDSCO, NABH, ICMR guidance