Good Clinical Practice: A Question & Answer Reference Guide - May 2018 - 6

GCP: A Question & Answer Reference Guide
Review Boards, Clinical Investigators, and Sponsors"-most of the current 25 guidances are dated September
1998, while several have been updated or added since 2006.
After 398 inspections from 2000 to 2012 the European Medicines Agency (EMA) summarized the findings into
Critical and Major and to address these concerns from GCP inspections in June 2015, the ICH released an amended
version of the international guidelines for GCP: ICH GCP E6 (R2). There are 26 new items that were amended;
the three main areas of clinical research are data management, sponsor and investigator responsibilities. At the time
of publishing, approximately 35% of industry has begun working on assessing their respective compliance to the
new amendments leaving ~65% of industry as not started.
1.2

Q. What other new regulations and/or guidances can we expect to see in the near future?

A. The Clinical Trial Regulation (CTR) implementation has been pushed back from October 2018 to 2019;
many companies within industry are working on meeting the new regulation. Industry is focusing on building
awareness and understanding of the new clinical trial regulatory framework within Europe to assess the systems
and processes that are already in place and that will need to be revisited and possibly revised to ensure compliance
with the European regulatory requirements. This is important to companies to know that all clinical studies will
be designed, conducted, recorded and reported to the standards of the CTR by 2019. Another point of interest to
industry will be how these standards will be applied during inspections moving forward. The CTR and the ICH E6
R2 will be the most important changes to the clinical research arena for many years.
1.3

Q. What are the key benefits of the Clinical Trial Regulation?

A. It is designed to harmonize electronic submissions and assessment process for the clinical trials conducted in
multiple Member States in Europe. It will also improve and foster collaboration, information-sharing and decisionmaking between and within Member States. In addition, it will further increase transparency of information on
clinical trials and drive higher standards of safety for all participants in EU Trials.
1.4

Q. What is the EU clinical trial portal and database and when will it be implemented?

A. The EU clinical trial portal and database will be the single entry point for submitting clinical trial information
in the EU, which will be stored in the database that will be available publicly; however, these data will
be subject to transparency rules within the EU. The system will contain collaboration tools, workflow and
document management capabilities, which will provide access via individual workspaces within the EU
clinical trial and portal and database.
B.

The EU clinical trial portal and database will be the single entry point for clinical trial application forms,
public registration, any subsequent updates and supporting dossier that will cover all regulatory and ethics
assessments from Member States concerned.

Secure Sponsor workspaces will be provided and is designed to assist clinical trial sponsors in preparing and
compiling data to submit to the database for assessment by Member States.

D. Authority workspace will allow for Member States and the European Commission to oversee clinical trials.
E.

As mentioned in H.4A, it will provide members of the public to access detailed information on all clinical
trials conducted in the EU, in all official languages.

At the time of publishing, the EMA is developing plans for the implementation of the EU clinical trial portal
and database and are currently planning on having an auditable version by early 2019 as required by the
Clinical Trial Regulation.

1.5

Q. Have there been any changes within the U.S. Food and Drug Administration regarding the Compliance
Program Guidance Manuals?

A. Yes, the U.S. Food and Drug Administration Compliance Program Guidance Manual (CPGM) for Sponsors,
Contract Research Organizations and Monitors, CPGM 7348.810 has been revised as of April 19, 2017. CPGM
7348.810 has been revised to include Program Assignment Code 98810, Tobacco Products. The majority of the
revisions are found in section D.
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Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2018