Staff Qualification, Training and Training Records

1. Purpose

This SOP describes how [SITE NAME] confirms that each person working on clinical research is qualified by education, training and experience for their tasks, what training they complete and when, how competency is checked, and how qualification and training records are kept so they can be shown to sponsors, IRBs and inspectors.

2. Scope

This SOP applies to all investigators, staff, contractors and per diem or agency staff who perform research tasks at any [SITE NAME] location. It covers the staff qualification file, required training, protocol and SOP training, system training, shipping training, competency checks and training records. Onboarding steps outside training are in SOP-102 Site Organization, Roles and Staff Responsibilities. Delegation of study tasks is in SOP-302 Delegation of Authority.

Follow the protocol, sponsor or IRB requirement where it is stricter than this SOP (for example, a sponsor that requires GCP refresher training more often, or a CV signed within the last year).

3. Responsibilities

4. Definitions

5. Procedure

5.1 Role-based curricula

5.2 Qualification file

• current CV or biosketch, signed and dated by the person, showing education, research experience and current position at [SITE NAME]
• signed role description (SOP-102)
• copy of each professional license or certification required for the role (for example, MD/DO, NP, PA, RN, LPN, pharmacist, phlebotomy, medical assistant), with primary-source verification from the issuing board's website, printed or saved with the date checked
• DEA registration and any [STATE] controlled-substance registration for investigators who prescribe, dispense or order controlled substances
• results of exclusion and debarment checks (5.2.3)
• GCP training certificate (5.3)
• human subjects protection training, when required (5.4)
• HIPAA and privacy training record
• bloodborne pathogens training for staff with occupational exposure, as required by OSHA (29 CFR 1910.1030)
• basic or advanced life support certification where the role or protocol requires it
• IATA and DOT shipping training for hazmat employees (5.7)
• SOP training acknowledgments (F-100-02 SOP Training Acknowledgment)
• the staff member's F-103-01 Staff Training Log
• signed confidentiality agreement and onboarding checklist (SOP-102)

5.3 GCP training

5.4 Human subjects protection training

5.5 SOP training

5.6 Protocol training

5.7 Shipping training (IATA and DOT)

• DOT hazmat training covering general awareness, function-specific, safety and security awareness content, within 90 days of starting the function (working only under direct supervision of a trained employee until then) and repeated at least every 3 years (49 CFR 172.704)
• IATA Dangerous Goods Regulations training for air shipments, repeated within 24 months of the previous training

5.8 System training

• sponsor systems (EDC, IRT, eCOA, ePRO, safety portals, imaging upload): the sponsor's or vendor's training, with the completion certificate or record filed in the ISF
• site systems (eRegulatory, CTMS, EMR, temperature monitoring, eConsent if site-deployed): training by the System Owner or vendor, recorded on F-103-01

5.9 Competency checks

• obtaining informed consent: the new consenter is observed by an experienced consenter or investigator for at least [DEFAULT: 2] consent discussions before obtaining consent alone
• phlebotomy and specimen processing (including centrifugation, aliquoting, labeling and freezing)
• vital signs and ECG acquisition per protocol specifications
• IP preparation, dispensing and accountability
• protocol-required rating scales, when the sponsor requires rater certification (the sponsor's certificate is the record)

5.10 Training records

• trainee name
• topic and document identifier with version (SOP number and version, protocol number and amendment number)
• date
• method (read and acknowledge, instructor-led, web course, observation)
• trainer or provider
• trainee signature or electronic acknowledgment

5.11 Review and readiness

6. Related Forms and SOPs

• F-100-02 SOP Training Acknowledgment
• F-102-01 Site Organization Chart and Role Assignment Record
• F-103-01 Staff Training Log
• F-103-02 Staff Qualification File Checklist
• F-302-01 Delegation of Authority Log
• F-904-01 Shared Staff Assignment and Credentialing Log (Model N only)
• Appendix B Central and Site Responsibility Matrix (Model N only)
• SOP-100 Writing, Approving and Controlling SOPs
• SOP-102 Site Organization, Roles and Staff Responsibilities
• SOP-204 Essential Documents and the Investigator Site File
• SOP-302 Delegation of Authority
• SOP-311 Biological Specimen Collection, Processing and Shipping
• SOP-401 Computerized Systems and Electronic Records
• SOP-402 Record Retention, Archiving and Destruction
• SOP-703 Corrective and Preventive Action (CAPA)
• SOP-704 Research Misconduct and Fraud Reporting
• SOP-904 Shared Staff, Cross-Site Coverage and Central Services (Model N only)

7. References