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Philip Ward is ACT's European editor, phone +44 1244 538583, firstname.lastname@example.org
A statement issued by the European Forum for GCP (EFGCP) states that provided further updates are made, the ICH guideline for Good Clinical Practice (E6) can stay relevant for another 20 years.
Provided further updates are made, the ICH guideline for Good Clinical Practice (E6) can stay relevant for another 20 years, according to a statement issued by the European Forum for GCP (EFGCP).
“The changing way we conduct research has meant that the guideline needs an update, and the E6 addendum aims to accomplish that,” EFGCP noted. “The EFGCP welcomes the update of the E6 guidance document, and the changes which will facilitate its application to electronic systems. The acknowledgement of risk-based trial activities is helpful and will keep the guideline in harmony with many recent regulatory developments.”
Discussions are ongoing, and the ICH business plan anticipates finalization in November 2016 and regulatory implementation in mid-2017. The guideline has always been tripartite, but as well as including the EU, Japan and the U.S., both Canada and Switzerland are specifically mentioned in the scope, EFGCP continued.
EFGCP has given the following feedback on the document: references to “original” and “copy” documents should be removed from section 8 (essential documents) because with electronic documents these concepts are less applicable; definitions are necessary for new terms in the addendum, especially within quality risk management; and requirements for the investigator to have control of and continuous access to the case report form (CRF) supplied to the sponsor are currently difficult to meet. The use of a third-party vendor to hold the eCRF may give the required degree of protection to the document, EFGCP suggests.
In the document, sponsors are urged to avoid unnecessary complexity, procedures, and data collection, and this is a frequent cause of clinical trial problems. “It will be interesting to see if regulators similarly push for simplification of our trials,” continued the statement.
Centralized monitoring is recognized, with the aim of identifying missing data, inconsistencies, outliers and a lack of variability, and the use of statistics is encouraged to identify trends, looking at the range and consistency of data across sites. Also, the guideline requests that monitoring plans emphasize critical data and processes, giving a rationale for their selection. It suggests that applicable policies and procedures are referred to in support of the plan.
“It is worth noting that inadequate justification of monitoring sampling plans has been the recent cause of many inspection findings. Both the sponsor and investigator should record the location of their essential documents with a view to future document identification, search and retrieval,” EFGCP stated. “The sponsor should not have exclusive control of CRF data, as has been the position in an EMA (European Medicines Agency) reflection paper. This is an ongoing challenge for clinical researchers.”
To read the full statement, click here.