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What's new in the Good Clinical Practices E6 Guide published by ICH

In November 2016 an addendum to the 1996 version of the ICH (International Council for Harmonization) “Good Clinical Practices” guide was finalized and made available on the ICH website ( See below for more information on this. After all, this guide is the “bible” for conducting a clinical study wherever it is being conducted.

Why was a review of the GCP (Good Clinical Practices) necessary?

Since 1996, when ICH E 6 - GCP was adopted worldwide, the scenario of clinical studies has developed and changed substantially.

We have seen an increase in globalization, complexity of clinical studies and inclusion of technologies that did not exist in 1996.

The GCP approach needed modernization to be able to match the large scale and complexity of the studies and ensure adherence to the appropriate use of technology constantly incorporated during the conduct of clinical studies.

GCP also needed to be modernized to consider the critical aspects of the studies including not only the data itself, but also its financial aspects.

The initial version of ICH –GCP (E6 - R1) has been updated with an addendum to encourage the implementation of more efficient approaches to clinical studies with respect to their designs, methods of conduct, supervision, reporting and data recording, without subject protection and data reliability being compromised in any way.

This addendum is available with the included changes highlighted from the original text of the initial version.

The aforementioned addendum R2 replaces the initial version and if there is any conflict in the texts of the initial version R1, addendum R2 will have priority.

What's new in version R2?

See below the main topics that were included and / or updated in this addendum:

• Consideration of certified copies (section 1.63)

• Concept of the monitoring plan (1.64)

• Validation of computing systems (1.65)

• Inclusion of other types of media for study data records (2.10)

• Systems that provide quality must be focused on those aspects of the study that are essential to the protection of subjects and data reliability (2.13)

• The investigator must supervise individuals or third parties to whom functions of studies have been delegated (4.2.5)

• Investigator must ensure that individuals or third parties are qualified and implement procedures to ensure the integrity of the study data (4.2.6)

• Investigator must keep accurate documents and study records (4.9.0)

Study data must be “attributable, legible, contemporary, original, accurate and complete” (ALCOA + C).

This categorization was already covered by the FDA (Food and Drug Administration in the United States) and EMA (European Medicine Association) and is now also included in the GCP.

Section 5 of the GCP now contemplates a complete topic on quality management of the study as being the responsibility of the sponsor, in a more complete and current way. In this same section we observe the use of a risk analysis approach for this quality management, including several steps for this management, such as:

• Identification of critical processes (5.0.1),

• Identification of risks to critical data and processes (5.0.2),

• Risk assessment (5.0.3),

• Risk Control (5.0.4), risk communication (5.0.5), risk review (5:06) and reporting the same (5.0.7).

Still within the sponsor's responsibilities, it is considered:

• Inclusion of CROs (Contract Research Organizations) in sections 5.2.2 and the validation of computer systems and their relevance to ensure the integrity of the data produced (section 5.5.3).

• Need for root cause analysis for any problem that could significantly jeopardize the safety of the research participant and the implementation of corrective and preventive actions (5.20.1).

• Risk based monitoring (5.18.3, 5.18.6 and 5.18.7).

• Location or filing system of essential documents with the widest consideration, as long as the identification, versions, search and ease of retrieving the documents are provided.

As everything in research develops, the GCP could not fail to have an update, even after so many years.

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