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

Case Report Forms and Study Data. (a) PSI shall supply to the Investigative Site forms to be used and completed by the Investigator to document a Study Subject’s participation in the Study (such forms are referred to as “Electronic Case Report Forms”). The Investigative Site shall ensure that the Investigator reviews all patient Electronic Case Report Forms to assure their accuracy and completeness, and assist PSI and its representatives (including clinical monitors) upon their request in prompt resolution of any discrepancies or errors contained in the Electronic Case Report Forms and in review, verification, inspection and/or auditing of the Study Subjects’ records, laboratory reports, or other raw data sources supporting the data recorded on the Electronic Case Report Forms. The Investigative Site shall ensure that the Investigator signs and dates the Electronic Case Report Forms for each Study Subject.

Case Report Forms and Study Data. (a) PSI shall supply to the Investigative Site forms to be used and completed by the Investigator to document a Study Subject’s participation in the Study (such forms are referred to as “Electronic Case Report Forms”). The Investigative Site shall ensure that the Investigator reviews all patient Electronic Case Report Forms to assure their accuracy and completeness, and assist PSI and its representatives (including clinical monitors) upon their request in prompt resolution of any discrepancies or errors contained in the Electronic Case Report Forms and in review, verification, inspection and/or auditing of the Study Subjects’ records, laboratory reports, or other raw data sources supporting the data recorded on the Electronic Case Report Forms. The Investigative Site shall ensure that the Investigator signs and dates the Electronic Case Report Forms for each Study Subject.