GCP training for ICH E6(R3)

GCP training should show that you can apply Good Clinical Practice to a real decision, not only that you finished a module. CRLN scores trial decisions against ICH E6(R3), the current revision of the ICH guideline for Good Clinical Practice, so you see where your judgment holds and where it needs work.

This guide explains what ICH E6(R3) is, what changed from E6(R2), who needs GCP training, how refresher training is set, and how CRLN's ICH E6(R3) GCP course works.

What ICH E6(R3) is

Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve human participants. Following it protects the rights, safety and well-being of participants and makes trial results credible.

ICH E6 is the guideline that sets out GCP for the regulators and industry members of ICH. ICH E6(R3), the third revision, was adopted by ICH in January 2025. Each regulator then brings it into effect in its own region on its own timeline, so check what your regulator and your sponsor expect.

What changed from E6(R2)

E6(R3) keeps the core of GCP and changes how a trial is expected to get there. It is written to apply across trial designs and settings, and it asks for effort in proportion to risk rather than the same effort on everything. The main changes:

Quality by design: quality is built in from the start. The sponsor identifies the factors critical to quality, the things that matter most for participant protection and reliable results, and designs the protocol and processes around them.
Risk-proportionate approaches: oversight, monitoring and documentation are scaled to the risks a trial actually carries, instead of the same level of checking on every data point and every task.
Data governance: clearer expectations for the whole life of trial data. Who is responsible for it, how it is captured, changed, protected and retained, and how its integrity is shown, including metadata and audit trails.
Technology: computerized systems, electronic records and decentralized or remote trial elements are addressed directly, with the expectation that systems are fit for purpose and their use is controlled.
Investigator oversight of delegated parties: the investigator remains responsible for trial work done for the site, including work delegated to staff and to service providers, and supervises it in proportion to its importance and risk.

For people working on trials, the practical effect is that more decisions call for judgment. Knowing the rule is the start. Choosing the proportionate response is the skill.

Who needs GCP training

Anyone whose work on a trial could affect participant safety or the reliability of the data is generally expected to be trained in GCP to the extent their role requires. That usually includes:

Investigators: the Principal Investigator and every Sub-Investigator.
Site staff: Clinical Research Coordinators, Research Nurses, Research Assistant / Study Coordinator I staff, Clinical Trial Pharmacists, Decentralized Trial Coordinators and Specimen Processing / Laboratory Technicians.
Sponsor and CRO staff: Clinical Research Associates, Clinical Trial Assistants, Clinical Trial / Project Managers, Clinical Data Managers, Regulatory Affairs Specialists and Pharmacovigilance / Drug Safety Associates.

The depth differs by role. A coordinator who obtains consent needs more than someone who only schedules visits, and the delegation log should show that each person is trained for the tasks they do.

How often GCP refresher training is expected

There is no single global rule for how often GCP training must be renewed. Sponsors, CROs, institutions and ethics committees set their own expectations, and a study may ask for training on a specific revision before staff begin work on it.

In practice, check three places: the sponsor's requirements for the study, your institution's or employer's policy, and any requirement of the ethics committee. When the guideline itself is revised, as it was with E6(R3), expect to be asked for training on the new revision even if your last course was recent.

CRLN's ICH E6(R3) GCP course

CRLN's GCP course is an ICH E6(R3) course in the Practice Lab. Lessons open without an account. An account is needed only to save progress and to earn the free credential.

CRLN's ICH E6(R3) GCP course is listed in TransCelerate's GCP Training Mutual Recognition Program by self-attestation to TransCelerate's published minimum criteria. TransCelerate does not review, accredit or endorse course content, and whether to accept the course is each sponsor's decision.

What sets it apart is what comes after the lessons. Every role track in the Practice Lab has decision scenarios scored against ICH E6(R3) and mapped to a competency domain in the open standard CRLN-TRG-001, so you can show how you apply GCP in your role, not only that you read about it.

Scores describe performance in simulation. They are not a license or a certification.

Open the ICH E6(R3) GCP course: https://crln-practice-lab.crln-learn.com/learn/gcp-ich-e6-r3

Frequently asked questions

What is GCP training?

Training in Good Clinical Practice, the international ethical and scientific quality standard for clinical trials. It covers participant protection, informed consent, safety reporting, data integrity, following the protocol, and the responsibilities of investigators and sponsors.

What is ICH E6(R3)?

The third revision of the ICH guideline for Good Clinical Practice, adopted by ICH in January 2025. It puts weight on quality by design, risk-proportionate approaches, data governance, the controlled use of technology, and the investigator's oversight of delegated work.

How often do I need GCP refresher training?

There is no single global rule. Sponsors, CROs, institutions and ethics committees set their own expectations, so check the study's requirements and your employer's policy.

Will sponsors accept CRLN's GCP course?

Does CRLN's GCP course cost anything?

No, for learners and research sites. Lessons open without an account, and an account is needed only to save progress and to earn the free credential.

How is decision-based practice different from a GCP course?

A course teaches the rules and often ends with a short quiz. Decision-based practice puts you in a realistic trial situation and scores what you choose to do, so it shows whether you can apply the rules under time pressure.