The electronic case report form (also called electronic data capture or EDC) is a staple of modern day clinical research.  The eCRF has replaced the paper CRF is many studies it is more efficient and more cost effective.

Just as the investigator signs the paper CRFs to demonstrate oversight and compliance with section 4.9.1 of GCP, so must the investigator sign the electronic eCRF.  Electronic signature occurs by entering the Principal Investigator’s unique username and password.  For this reason, it is important the Principal Investigator does not share his/her login details.  Periodic review the eCRF for accuracy, completeness and timeliness of entry will allow the PI to sign the eCRF with confidence when required.

The training associated with access to eCRF/EDC systems can be onerous at times and many PIs see little benefit in completing the training.  However, it is important for compliance with GCP that the Investigator completes all training and as familiarity with the eCRF platforms is gained, this training becomes quicker.


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