Good Practice Action 9: Provide continual training beyond GCP

Provide continual training, structured learning, and mentorship to build trial team competencies that go beyond current Good Clinical Practice (GCP) training

Building trial team capability requires ongoing, skills-based training and mentorship that translates Good Clinical Practice (GCP) into consistent, high-quality conduct across all stages of a trial.

Team competencies and capabilities are elevated, and this helps to underpin delivery of a high-quality trial. Without attention to this, there may be gaps in knowledge; missed opportunities; and risks which could violate the trial’s integrity.  Overall, continuous training and development builds in better quality.

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Trial teams and others should:

Diversity within trial teams contributes to clinical innovation, builds trust within a healthcare system, and improves recruitment and retention rates for clinical trials (Blumenfeld, 2025Getz et al., 2022).  Revising hiring practices can be an approach to widen team diversity by:

  • writing inclusive job descriptions
  • reaching out to diverse professional networks
  • minimising interview bias
  • blinding application submissions
  • using AI to analyse recruitment processes

Research teams should plan for ongoing and structured learning for the team from the beginning and throughout the trial lifecycle. All team members will develop their skills to ensure compliance and quality, and participant safety.

Mentorship can support earlier stage professionals progress into leadership roles. Structured programs that pair junior staff with experienced mentors can build confidence, provide guidance on career pathways, and increase retention of under-represented groups in clinical research.

Trial teams must plan for effective trial site initiation training, in which the research team all understand the informed consent process, study procedures, data collection and management methods, equipment and software use, and regulatory requirements.

An example of study site collaboration to standardise methodology for a RCT is shown in the Saving and Empowering Young Lives in Europe (SEYLE)  study (Carli et al., 2013). Two approaches were used across the 11 European countries taking part:

  1. A detailed 328-page procedures manual containedinformation about every aspect of thestudy implementation(school selection; recruitment; randomisation; clinical input; ethics; translation and cultural adaptation procedures; details about the interventions and their timelines; and questionnaires).
  2. Standardised training procedures: Central training for site leaders, centrally in Stockholm (train the trainer), followed by local roll-out (27 hours of training group work, including 4 hours per intervention). The fidelity of the methods training was then checked and monitored by site visits and assessment, allowing for correction of any misunderstandings and further training.

Collaboration across the sites as a key objective was ongoing throughout implementation, conduct and until completion (Carli et al., 2013).

In addition to technical skills, the following areas could be included in planned training, development and mentorship:

Communication – Effective communication can break down barriers within clinical trials that otherwise could derail the trial. Clear and understandable information, and appropriate and well considered formats can be used engage everyone involved in a way that encourages inclusion and confidence in involvement. Inclusive language is important and resources such as the Inclusive Practice Glossary (Collaborative Capacities) is helpful to refer to. An environment of psychological safety is a key development for clinical trial communications and activities to operate within.

Unconscious bias and building empathy are further important areas for trial team members to develop their skills and knowledge to support quality clinical research.

Inclusive practices – WHO advocates for the inclusion of under-represented populations in the planning, conduct, analysis, oversight, interpretation, and

funding of all clinical trials. Without this, trials will lack quality, be unethical, and will not provide the evidence that matches the people for whom the results were intended to help (Volkmer, 2025).

Inclusion is not optional. It’s central to generating reliable, actionable evidence that serves all populations.” (WHO, 2025).

Collaboration – Resources about building trusted relationships with stakeholders can be found in Good Practice Action 3.

How funders can ensure this happens

  1. Encourage research teams to engage with resources such as those above to plan for trial team training, development and cross-site collaboration. .
  2. Ask research teams about their specific plans (beyond GCP) for training, learning and mentorship for everyone in the team, throughout the whole trial lifecycle. Specifically ask them to describe the training that will be provided to those involved in delivering the trial to participants. Describe how training needs will be monitored throughout the trial and updated as needed.
  3. An example question to ask is given in the INFORM Structured Grant Form, Question {30}
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