From the sponsor’s perspective it is monitor’s responsibility www.selleckchem.com/products/Tipifarnib(R115777).html to verify that source documents and other trial records are accurate, complete, and appropriately maintained. Once AV recording becomes a regulatory requirement in India, the monitor would be required to review the IC process and bring any deficiencies to the notice of investigator. The monitor will have to take all reasonable precautions within the applicable regulatory framework to maintain confidentiality of subjects?? identity and ensure that these recordings are maintained under secured access. Extensive training will have to be imparted to the monitor to fulfill this responsibility. Language barrier In case of audits and inspections, it will become challenging for auditor/inspector to confirm if the process was adequately performed since he or she may not familiar with the language used and may need a translator.

Cost implication The cost implication of recording consent process for each and every informed consent discussion cannot be undermined. The activity has a potential to shoot the clinical trial budget significantly. Consider in a study with large sample size and high screen failure rate, each and every informed consent discussion will have to be recorded, irrespective of whether the participant agrees or refuses to consent at the end of the discussion. In addition, the records of all participants who have consented but screen failed due to any inclusion and exclusion criteria will have to be archived, which adds to the cost.

Special populations AV recording of the consent process in studies enrolling patients treated in emergency conditions and critical cases will be a problem. In addition, for the illiterate Brefeldin_A patients, the impartial witness and for participants not able to consent for themselves selleck inhibitor a LAR will have to be included in the recording. The assent from the minor will also have to be captured in the recording. Risk of tampering the records The ICFs are maintained with original signatures and though tampering the signed document is possible, it is quite difficult and may be relatively easier to detect. However with advances in technology, tampering of the AV recording may become easier and difficult to detect. Hence, ensuring controlled access and robust IT policies (including an audit trail) will be required in order to be in place to avoid any misuse of the records. How long would this information be stored for and what happens at the end of a trial would need to be defined and discussed with the regulators. CONCLUSION AV recording of the consent process will definitely help to record the actual consent process, but ascertaining that the participant has voluntarily consented still remains debatable.