INDEMNIFICATION. If required by the applicable regulatory requirement(s), the sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator/the institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence. (ICH E6 5.8.1) The sponsor's policies and procedures should address the costs of treatment of trial subjects in the event of trial-related injuries in accordance with the applicable regulatory requirement(s). (ICH E6 5.8.2) When trial subjects receive compensation, the method and manner of compensation should comply with applicable regulatory requirement(s). (ICH E6 5.8.3)
Appears in 2 contracts