The requirement for investigators to keep a copy of the CRF has been in existence for 20 years. (See for
example ICH GCP 8.3.14). It is the expectation of the EU GCP IWG that the copy held by the investigator
is a contemporaneous and independent copy of the CRF, i.e. that it is not held or has been held by the
sponsor. This requirement is valid irrespective of the media used; however, the introduction of electronic
CRFs in clinical trials presents an additional challenge in achieving this requirement – especially if data
are being submitted directly via a web based application. This issue has been identified by EU GCP
inspectors and discussed in the reflection paper EMA/INS/GCP/454280/2010 (see section 6.2 Specific
Requirements Topic 3: control).
Recent inspections have revealed a need to clarify this point.
Requirement 10 of the above reflection paper states the following: “The sponsor should not have
exclusive control of a source document. (Requirement 10, ICH GCP 8.3.13)”
The 12 requirements in the reflection paper originate from the CDISC standard and are therefore quoted
directly in the reflection paper. However, although the CDISC requirements specifically relate to source
data, the requirements is considered by the EU inspectors to be also applicable to transcribed data – as
stated in the reflection paper section 6.2. Therefore, the requirement of a contemporaneous and
independent copy of the CRF is valid irrespective of whether the CRF contains source data or only
transcribed data. The EU GCP inspectors do not consider the requirement above to be met if data are
captured in an electronic system and the data are stored on a central server under the sole control of the
sponsor. This is because the investigator does not hold a contemporaneous and independent copy of the
data.
The EU GCP inspectors do not have a preference for any specific solution e.g. a third party vendor, printed
data prior to transferring to the database or saving a contemporaneous copy at the investigator’s local
computer hard drive; the essential point is that choosing an electronic solution should not jeopardise the
credibility of data and should not result in lower quality as compared to a paper CRF. It is the
responsibility of the sponsor and the investigator to institute a process by which a contemporaneous and
independent copy of the CRF is available at the investigator site.
