Common use of Inspection by Competent Authority Clause in Contracts

Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately notify Biogen thereof and use their best efforts to obtain approval for Biogen or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply with the legitimate requirements of an inspection. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspection. The Institution also shall make the Investigator and other Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information.

Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, Institution and the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately notify Biogen thereof and use their best efforts to obtain approval for Biogen or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply with the legitimate requirements of an inspection. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspection. The Institution also shall make the Investigator and other Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information.

Inspection by Competent Authority. If a Competent Authority (national or foreign) wishes to inspect the Institution or the Investigator in connection with their participation in the Trial, then the Institution, Institution and the Investigator and Staff shall, to the extent reasonably practicable, (i) immediately without undue delay notify Biogen thereof and use their best efforts to obtain approval for Biogen or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply with the legitimate requirements of an inspection. This also includes the making available (for examination and duplication) of documentation, data and information relating to the Trial. Subject medical records shall be made available where required for source document verification procedures as part of the inspection. The Institution also shall make the Investigator and other Staff available to the relevant Competent Authority to explain and discuss such documentation, data and information.and