Guidance for Industry1
Electronic Source Data in Clinical Investigations
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
This guidance provides recommendations to sponsors, Contract Research Organizations (CROs),
clinical investigators, and others involved in the capture, review, and retention of electronic
source data in FDA-regulated clinical investigations.2
In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.
This guidance addresses source data in clinical investigations used to fill the predefined fields in
an electronic case report form (eCRF), according to the protocol. The guidance discusses the
following topics related to electronic source data:
Identification and specification of authorized source data originators
Creation of data element identifiers to facilitate examination of the audit trail by
sponsors, FDA, and other authorized parties
Ways to capture source data into the eCRF using either manual or electronic methods
Clinical investigator(s) responsibilities with respect to reviewing and retaining electronic
Use and description of computerized systems in clinical investigations