1. Purpose

To ensure every person who performs study-related duties at Quillbrook is qualified by education, training and experience, and that this qualification is documented before the person performs the delegated task.

2. Scope

Applies to all employees, temporary staff, students and contractors who participate in the conduct of clinical research, including investigators, coordinators, nurses, pharmacy, laboratory, data management, regulatory, recruitment, IT and administrative personnel with access to study records.

3. Responsibilities

• Training & Compliance Coordinator: Maintains the training matrix, assigns curricula, tracks due dates, and files training records.
• Principal Investigator: Delegates study tasks only to appropriately qualified persons and signs the delegation of authority log.
• Supervisors: Verify that new staff complete onboarding training before independent work and confirm ongoing competency.
• All Personnel: Complete assigned training by its due date, maintain a current CV and licence, and decline tasks they are not trained to perform.

4. Definitions

GCP

Good Clinical Practice, the international ethical and scientific quality standard for clinical trials, as described in ICH E6(R3).

Protocol-specific training

Training on the requirements of an individual study protocol, its amendments and its study-specific procedures.

Training log

The documented record of training completed, including topic, version, date, trainer and trainee signature.

Delegation of authority log

The investigator-signed record listing each staff member and the study tasks delegated to them, with start and end dates.

5. Procedure

1. Define a role-based core curriculum for every job title, including human subjects protection, GCP per ICH E6(R3), HIPAA privacy and security, site SOPs, and safety reporting.
2. Complete initial GCP training before performing any study-related duty, and refresh GCP training at least every three years.
3. Complete HIPAA privacy and security training within five business days of hire and annually thereafter, as required by HIP-001 and HIP-002.
4. Collect and file a signed and dated curriculum vitae for every staff member, updated at least every two years, together with current professional licences and certifications.
5. Complete protocol-specific training on the protocol, investigator's brochure, laboratory manual and study-specific procedures before performing any task on that study, and repeat for every substantive amendment.
6. Record every training event in the training log with the topic, document version, date completed, method of delivery, trainer name and trainee signature or validated electronic signature.
7. Assign read-and-understand training for each new or revised SOP with a default due date of thirty calendar days, and capture the acknowledgment electronically.
8. Add each staff member to the delegation of authority log only after the required training is documented, and have the Principal Investigator sign and date the entry.
9. Verify role-specific external certifications where applicable, such as IATA or DOT dangerous goods training for specimen shippers per CON-004 and temperature-monitoring training for pharmacy staff per CON-003.
10. Document a competency assessment for procedures with direct subject impact, such as informed consent administration, vital signs, phlebotomy and investigational product dispensing, using direct observation by a qualified assessor.
11. Review the training matrix monthly; notify staff fourteen days before a due date and escalate overdue items to the supervisor and then the department director.
12. Suspend a staff member's delegated tasks when a mandatory training item becomes more than thirty days overdue, and record the suspension and its resolution.
13. Update the delegation of authority log and revoke system access promptly when a staff member changes role or leaves, coordinating with IT & Security per HIP-002.
14. Retain all training records, CVs, licences and delegation logs in the regulatory binder or its validated electronic equivalent for the period defined in DAT-003.

6. References

• ICH E6(R3) Good Clinical Practice
• 21 CFR Part 312.53 — Selecting investigators and monitors
• 45 CFR Part 46 — Federal Policy for the Protection of Human Subjects (Common Rule)
• 45 CFR 164.530 — Administrative requirements, training
• REG-001 Regulatory Binder / Essential Documents Maintenance

7. Revision History

• v3.0 · Jan 11, 2022 — Added competency assessment by direct observation.
• v4.0 · Jun 04, 2024 — Updated GCP references to ICH E6(R3) and set three-year refresh.
• v5.0 · Feb 02, 2026 — Added suspension of delegated tasks for overdue mandatory training.