In view of mandatory requirements for conducting clinical trials including the ongoing trials, all investigators must apprise themselves of the existing rules and regulations related to clinical trials (https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/clinical-trials/). At the Institute they need to comply with the following:
- The investigator must obtain necessary regulatory approvals e.g. from DCGI and the IEC before starting any clinical trial.
- The trial must be registered at the ICMR clinical trial registry website. (ctri.nic.in)
- The investigators must undertake audio-visual recording of the consent from the participants. The recordings must be preserved, and confidentiality of the subject must be maintained. (CMET provides technical assistance in this matter)
- The investigator must report any expected SAE or suspected unexpected serious adverse reaction (SUSAR) to the IEC (SAE committee) within 24 hours of its occurrence.
- The investigators must periodically submit the progress of their trials to the IEC for the purpose of monitoring of the trial.
- The investigator must make adequate arrangements for compensation of the subjects either through the sponsor or insurance. If the trial is investigator initiated, then the investigator should make arrangement for providing compensation. Third party insurance for SAE and professional indemnity insurance for research staff involved in trial ensure adequate compensation mechanisms.