Electronic Case Report Forms and Study Documentation Clause Samples
The 'Electronic Case Report Forms and Study Documentation' clause governs the creation, management, and use of electronic records and documents related to a clinical study. It typically outlines requirements for how data must be entered, stored, and maintained in electronic case report forms (eCRFs), as well as the responsibilities for ensuring data accuracy and integrity. For example, it may specify who is authorized to access or modify study documentation and how changes are tracked. The core function of this clause is to ensure that all study data is reliably captured and documented in compliance with regulatory standards, thereby supporting data integrity and auditability throughout the study.
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.