What are the requirements for an eCRF?

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

The MHRA GCP Inspectorate recently informed about the requirements for eCRFs (electronic case report forms) in their inspectorates blog.

What is an eCRF?

According to the agency, the eCRF is "a mechanism for the investigator to enter data into an electronic system to transfer to the sponsor. It is a form of electronic data capture (EDC)".

The database is comprised of tables which store all clinical data. Data can be entered into these databases or via direct data transfers from other electronic systems. According to the MHRA, the data flow should be defined, in particular the identification and location of source data. In addition, the systems should permit data changes and authorizations by the investigator with a clear audit trail to verify data integrity.

MHRA´s GCP Inspection findings

The MHRA GCP inspectorate has noticed that not all eSystems have been designed with the correct functionality. During recent inspections the agency observed the following:

• The monitor has not reviewed the entered data against source data and the monitoring plans had not considered the verification of this data.
• Source data for which no other records were available. Without the full audit trail, it was not possible to verify what data was entered, when, by whom, and whether the data had changed at all.
• Data integrated into the eCRF can be amended and this has resulted in discrepancies between data entered in IRT (interactive response technology) and eCRF.
• Addition of protocol deviation forms into the eCRF for monitors to enter the information and the study management team to assess and document their review. 
• Database (which contained transcribed data from paper CRFs) was changed into an eCRF, without a sufficient risk assessment for data integrity.
• No controls in place to ensure the investigator’s entered data could not be amended by sponsor staff. 
• No verification or quality control of data entry documented. It was not possible to determine the accuracy of data transcription from paper records.
• Inconsistencies between the paper worksheets (source data) and data entered directly into the database.

More information is provided in the MHRA Inspectorate blog entitled Is your eSystem actually an eCRF (electronic case report form)?