Conducting your research to the required standard: GCP training

Good clinical practice (GCP) is a set of internationally recognised quality standards which must be followed when designing, conducting, recording and reporting clinical trials that involve people. We recommend that all researchers undertake our GCP training, which is available online.

There is a legal requirement for clinical trials of medicinal products (CTIMPs) to achieve a marketing licence to be conducted to GCP standards. Compliance with the main principles of GCP is also required for CTIMP trials where a licence is not being sought.

These standards are often adopted in a proportionate way for other types of study to ensure they are conducted in a manner that protects the rights, safety and wellbeing of research participants and that research data is reliable.

It is important the sponsor, researcher and all individuals working on the study are appropriately qualified and trained so they can deliver the study to the required standards.

To discuss whether you require GCP training or other training needs please contact the Health and Care Research Wales support and delivery service

GCP supporting documents

At Health and Care Research Wales we offer a range of training courses to meet your study requirements. We also provide a range of useful resources and templates to support you in best research practice.

Research factsheets and reference guides

GCP Reference Guide v2.4

Research awareness factsheet

Useful research documents

Decision tree for adverse event reporting

Useful research templates

Appointment checklist

Consent checklist audit tool

Consent insert

Curriculm Vitae

Delegation audit tool

Delegation of duties log

Document tracking log

File note

Investigator's site file contents (CTIMP)

Investigator's site file contents (non-CTIMP)

Principal Investigator oversight record

Source data/CRF audit tool

Supplies issue log

Telephone summary

Training log

Treatment allocation log

Version control log