Cooperation during Audit by Biogen. The Institution and the Investigator shall cooperate, and shall cause the Staff to cooperate, with Biogen and its contractors and agents in the event of any internal inspections or audits, upon reasonable notice and during normal business hours. Subject medical records will be made available where appropriate for the purpose of source document verification procedures as part of the inspection or audit. The Institution also shall make the Investigator and Staff available to Biogen and its contractors and agents to explain and discuss such documentation, data and information.
Appears in 3 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
Cooperation during Audit by Biogen. The Institution and the Investigator shall cooperate, and shall cause the Staff to cooperate, with Biogen and its contractors and agents in the event of any internal inspections or audits, upon reasonable notice notice, but no less than 3 days in advance,and during normal business hours. The Institution shall furthermore make available to Biogen and its contractors and agents (for examination and duplication) all documentation, data and information relating to the Trial. Subject medical records will be made available where appropriate for the purpose of source document verification procedures as part of the inspection or audit. The Institution also shall make the Investigator and Staff available to Biogen and its contractors and agents to explain and discuss such documentation, data and information.
Appears in 1 contract
Samples: Clinical Trial Agreement
Cooperation during Audit by Biogen. The Institution and the Investigator shall cooperate, and shall cause the Staff to cooperate, with Biogen and its contractors and agents in the event of any internal inspections or audits, upon reasonable notice and during normal business hours. The Institution shall furthermore make available to Biogen and its contractors and agents (for examination and duplication) all documentation, data and information relating to the Trial. Subject medical records will be made available where appropriate for the purpose of source document verification procedures as part of the inspection or audit. The Institution also shall make the Investigator and Staff available to Biogen and its contractors and agents to explain and discuss such documentation, data and information.
Appears in 1 contract
Samples: Clinical Trial Agreement