Common use of Case Report Forms and Study Data Clause in Contracts

Case Report Forms and Study Data. a) PSI shall supply (or if electronic, provide access to) the forms to be used and completed by the Investigator to document a Study subject’s participation in the Study (the “Case Report Forms” or “CRFs”). The Investigator shall record all data generated as a result of conducting the Study (the “Study Data”) within 5 business days, in an accurate and complete manner, and shall ensure that the Case Report Forms for each Study subject are duly signed and dated. To the extent the Study requires completion of electronic Case Report Forms, the Institution and the Investigator shall ensure that they have implemented and maintain appropriate computer security sufficient to protect the confidentiality, integrity and availability of such Study Data in accordance with the Applicable Regulatory Requirements. The Investigator shall not grant unauthorized users access to the electronic data capture (EDC) system used in the Study, and in particular, shall not share or disclose his/her username and/or passwords. b) The Institution and the Investigator shall take reasonable and customary precautions to prevent the loss or alteration of any Study Data. The Institution and the Investigator acknowledge and agree that the Sponsor shall own all Study Data.

Case Report Forms and Study Data. a) PSI shall supply (or if electronic, provide access to) the forms to be used and completed by the Investigator to document a Study subject’s participation in the Study (the “Case Report Forms” or “CRFs”). The Investigator shall record all data generated as a result of conducting the Study (the “Study Data”) within 5 business daysin a timely, in an accurate and complete manner, and shall ensure that the Case Report Forms for each Study subject are duly signed and dated. To the extent the Study requires completion of electronic Case Report Forms, the Institution and the Investigator shall ensure that they have it has implemented and maintain maintains appropriate computer security sufficient to protect the confidentiality, integrity and availability of such Study Data in accordance with the Applicable Regulatory Requirements. The Investigator shall not grant unauthorized users access to the electronic data capture (EDC) system used in the Study, and in particular, shall not share or disclose his/her username and/or passwords. b) The Institution and the Investigator shall take reasonable and customary precautions to prevent the loss or alteration of any Study Data. The Institution acknowledges and the Investigator acknowledge and agree agrees that the Sponsor shall own all Study Data.

Case Report Forms and Study Data. a) PSI shall supply (or if electronic, provide access to) the forms to be used and completed by the Investigator to document a Study subject’s participation in the Study (the “Case Report Forms” or “CRFs”). The Investigator shall record all data generated as a result of conducting the Study (the “Study Data”) within 5 business days, in an accurate and complete manner, and shall ensure that the Case Report Forms for each Study subject are duly signed and dated. To the extent the Study requires completion of electronic Case Report Forms, the Institution and the Investigator shall ensure that they have implemented and maintain appropriate computer security sufficient to protect the confidentiality, integrity and availability of such Study Data in accordance with the Applicable Regulatory Requirements. The Investigator shall not grant unauthorized users access to the electronic data capture (EDC) system used in the Study, and in particular, shall not share or disclose his/her username and/or passwords. b) The Institution and the Investigator shall take reasonable and customary precautions to prevent the loss or alteration of any Study Data. The Institution and the Investigator acknowledge and agree that the Sponsor shall own all Study Data.