Common use of Reporting and Documentation Clause in Contracts

Reporting and Documentation. 5.1 The medical institution agrees to duly complete and submit all requested data via the electronic data capture system, and in compliance with the Electronic Access Terms and Conditions. 5.2 The medical institution shall produce the documentation in a manner that makes it pertinent and useable for the project. In case of any ambiguity in respect to the manner of documentation, the medical institution shall immediately notify UNEV to clarify the issue. The medical institution acknowledges that the documentation as defined supra may be updated and amended from time to time by UNEV. 5.3 The medical institution shall correct incorrect data via the electronic data capture system as soon as the medical institution becomes aware of incorrect data. All corrections will be documented by the “audit trail” of the electronic data capture system. 5.4 The medical institution shall notify UNEV when a patient quits the project. The medical institution shall include in this notification the exact time of termination. In this case, UNEV shall immediately delete the patient data concerned. 5.5 The medical institution will take care that the source records are maintained and stored in a secure manner (in accordance with all applicable laws and regulations). 5.6 UNEV will take care that the project data entered in the electronic data capture system is maintained and stored in a secure manner (in accordance with all applicable laws and regulations). 5.7 UNEV shall ensure that the processing of results and data is consistent with provisions of data protection laws. 5.8 The medical institution hereby agrees to the processing of the investigator’s personal data provided to electronic data capture system by the investigator or obtained from other participating CARE centers. The Investigator has the right to have access to and correct his/her personal data. 5.9 The Investigator has the right to have access to and correct his/her entered data. 5.10 Adverse events and/or laboratory abnormalities identified in the entered data are not followed up by UNEV. The medical institution is in charge to take care of reporting these events in accordance with all applicable laws and regulations, if applicable.

Reporting and Documentation. 5.1 1) The medical institution agrees to duly complete and submit all requested data via the electronic data capture system, and in compliance with the Electronic Access Terms and Conditions. 5.2 2) The medical institution shall produce the documentation in a manner that makes it pertinent and useable for the project. In case of any ambiguity in respect to of the manner of documentation, the medical institution shall immediately notify UNEV to clarify the issue. The medical institution acknowledges that the documentation as defined supra may be updated and amended from time to time by UNEV. 5.3 3) The medical institution shall correct incorrect data via the electronic data capture system as soon as the medical institution becomes aware of notifies incorrect data. All corrections will be documented by the “audit trail” of the electronic data capture system. 5.4 4) The medical institution shall notify UNEV when a patient quits the project. The medical institution shall include in this notification the exact time of termination. In this case, UNEV shall immediately delete the patient data concerned. 5.5 5) The medical institution will take care that the source records are maintained and stored in a secure manner (in accordance with all applicable laws and regulations). 5.6 6) UNEV will take care that the project data entered in the electronic data capture system is maintained and stored in a secure manner (in accordance with all applicable laws and regulations). 5.7 7) UNEV shall ensure that the processing of results and data is consistent with provisions of data protection laws. 5.8 8) The medical institution hereby agrees to the processing of the investigator’s personal data provided to electronic data capture system by the investigator or obtained from other participating CARE centersthird parties. The Investigator has the right to have access to and correct his/her personal data. 5.9 9) The Investigator has the right to have access to and correct his/her entered data. 5.10 10) Adverse events and/or laboratory abnormalities identified in the entered data are can not be followed up by UNEV. The medical institution is institutions are in charge to take care of reporting these events in accordance with all applicable laws and regulations, if applicable.

Reporting and Documentation. 5.1 1) The medical institution agrees to duly complete and submit all requested data via the electronic data capture system, and in compliance with the Electronic Access Terms and Conditions. 5.2 2) The medical institution shall produce the documentation in a manner that makes it pertinent and useable for the project. In case of any ambiguity in respect to of the manner of documentation, the medical institution shall immediately notify UNEV to clarify the issue. The medical institution acknowledges that the documentation as defined supra may be updated and amended from time to time by UNEV. 5.3 3) The medical institution shall correct incorrect data via the electronic data capture system as soon as the medical institution becomes aware of notifies incorrect data. All corrections will be documented by the “audit trail” of the electronic data capture system. 5.4 4) The medical institution shall notify UNEV via the electronic data capture system when a patient quits the project. The medical institution shall include in this notification the exact time of termination. In this case, UNEV shall immediately delete the patient data concerned. 5.5 5) The medical institution will take care that the source records are maintained and stored in a secure manner (in accordance with all applicable laws and regulations). 5.6 6) UNEV will take care that the project data entered in the electronic data capture system is maintained and stored in a secure manner (in accordance with all applicable laws and regulations). 5.7 7) UNEV shall ensure that the processing of results and data is consistent with provisions of data protection laws. 5.8 8) The medical institution hereby agrees to the processing of the investigator’s personal data provided to electronic data capture system by the investigator or obtained from other participating CARE centersthird parties. The Investigator has the right to have access to and correct his/her personal data. 5.9 9) The Investigator has the right to have access to and correct his/her entered data. 5.10 10) Adverse events and/or laboratory abnormalities identified in the entered data are can not be followed up by UNEV. The medical institution is institutions are in charge to take care of reporting these events in accordance with all applicable laws and regulations, if applicable.