Informed consent process (a) Description of the general process for obtaining informed consent, including the process for providing subjects with new information, as needed. (b) Description of the informed consent process in circumstances where the subject is unable to give it; in the case of emergency treatment, process should be clearly specified. 1.14 Adverse events, adverse device effects and device deficiencies (a) Definitions of adverse events and adverse device effects. (b) Definition of device deficiencies. (c) Definitions of serious adverse events and serious adverse device effects and, where appropriate, unanticipated serious adverse device effects. (d) Time period in which the principal investigator shall report all adverse events and device deficiencies to the sponsor and, where appropriate, to Ethics Committee and the regulatory authority. (e) Details of the process for reporting adverse events (date of the adverse event, treatment, resolution, assessment of both the seriousness and the relationship’ to the investigational medical device). (f) Details of the process for reporting device deficiencies. (g) List of foreseeable adverse events and anticipated adverse device effects, together with their likely incidence, mitigation or treatment. (h) Emergency contact details for reporting serious adverse events and serious adverse device effects.Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 187 of 248 1.15 Vulnerable population (a) Description of the vulnerable population. (b) Description of the specific informed consent process. (c) Description of the Ethics Committee specific responsibility. (d) Description of what medical care, if any, will be provided for subjects after the clinical investigation has been completed. 1.16 Suspension or premature termination of the clinical investigation (a) Criteria and arrangements for suspension or premature termination of the whole clinical investigation or of the clinical investigation in one or more investigation sites. (b) Criteria for access to and breaking the blinding or masking code in case of suspension or premature termination of the clinical investigation, if the clinical investigation involves a blinding or masking technique. (c) Requirements for subject follow-up.