FDA Guidance on Electronic Case Report Forms (eCRF)
Do the original copies of the signed, dated and completed CRFs as well as documentation of CRF corrections need to be maintained by the study sponsor?
No. This is stated in ICH E6, but that is just a guidance, not a requirement. It is the sponsor’s decision to determine who maintains the original document (from 2013).
Documentation available in the Florence Library of FDA eRegulatory and eSource Guidance
Can the sponsor require that only the PI enter the causality and severity data into eCRF?
No, investigators can delegate transcription of source data into case report forms and other certain study-related tasks. When those tasks are delegated to qualified people, the investigator should provide adequate supervision of those to whom tasks are delegated (from 2015).
Documentation available in the Florence Library of FDA eRegulatory and eSource Guidance
While preparing an eCRF for a retrospective collection study, there is a data item identified as a nationality when it should be an ethnicity, can we change the data item to be ethnicity (nationality) to include that data point?
It depends. FDA regulations are not specific when it comes to preparing eCRFs, so sites are free to develop their own procedures (from 2014).
Documentation available in the Florence Library of FDA eRegulatory and eSource Guidance
What are the guidelines regarding using eCRFs as source documents when they are maintained externally and routing access to study data is limited to study personnel and data managers?
The EMR can be a data originator for an eCRF and there should be adequate controls in place to ensure the reliability, quality, and integrity of the electronic source data, The guidelines are discussed in part 11 (although that is not assessed for EMRs) and the electronic source data in clinical investigations document (from 2015).
Documentation available in the Florence Library of FDA eRegulatory and eSource Guidance
The summaries presented in our library are for informational purposes only, they are not for implementation in operations. Please consult official FDA guidance documents for operational use.
