Common use of Electronic Case Report Forms and Study Documentation Clause in Contracts

Electronic Case Report Forms and Study Documentation. (a) Institution and Investigator will submit data using the electronic data capture system provided by MedImmune or CRO. Electronic Case Report Forms (“eCRFs”) will be used to record all of the required clinical and laboratory data in a timely manner in accordance with designated Study procedures. Institution and Investigator will be responsible for data entry. Data entry should occur within three (3) days of a Study subject visit. Site staff will be expected to respond to any electronic data queries within five (5) days of their creation. All eCRFs for each Study subject will be signed by the Investigator, or Investigator’s appropriate designee, within five (5) days of being notified that the data for the last completed Study subject visit has been locked. Investigator shall be responsible for reviewing the complete eCRFs to ensure their accuracy. MedImmune and/or its designated representative will provide training on the electronic data capture system to Investigator and Institution’s Study staff and will provide access to a twenty- four (24) hour help desk during the course of the Study to respond to questions regarding use of the electronic data capture system.

Electronic Case Report Forms and Study Documentation. (a) Institution and Investigator will submit data using the electronic data capture system provided by MedImmune or CRO. Electronic Case Report Forms (“eCRFs”) will be used to record all of the required clinical and laboratory data in a timely manner in accordance with designated Study procedures. Institution and Investigator will be responsible for data entry. Data entry should occur within three (3) days of a Study subject visit. Site staff will be expected to respond to any electronic data queries within five (5) days of their creation. All eCRFs for each Study subject will be signed by the Investigator, or Investigator’s appropriate designee, within five (5) days of being notified that the data for the last completed Study subject visit has been locked. Investigator shall be responsible for reviewing the complete eCRFs to ensure their accuracy. MedImmune and/or its designated representative will provide training on the electronic data capture system to Investigator and Institution’s Study staff and will provide access to a twenty- twenty-four (24) hour help desk during the course of the Study to respond to questions regarding use of the electronic data capture system.

Electronic Case Report Forms and Study Documentation. (a) Institution and Investigator will submit data using the electronic data capture system provided by MedImmune or CRO. Electronic Case Report Forms (“eCRFs”) will be used to record all of the required clinical and laboratory data in a timely manner in accordance with designated Study procedures. Institution and Investigator will be responsible for data entry. Data entry should occur within three (3) days of a Study subject visit. Site staff will be expected to respond to any electronic data queries within five (5) days of their creation. All eCRFs for each Study subject will be signed by the Investigator, or Investigator’s appropriate designee, within five (5) days of being notified that the data for the last completed Study subject visit has been locked. Investigator shall be responsible for reviewing the complete eCRFs to ensure their accuracy. MedImmune and/or its designated representative will provide training on the electronic data capture system to Investigator and Institution’s Study staff and will provide access to a twenty- twenty-four (24) hour help desk during the course of the Study to respond to questions regarding use of the electronic data capture system.