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This SOP guides clinical sites in collecting, documenting, and maintaining investigator financial disclosures in compliance with 21 CFR Part 54. It ensures site staff understand their responsibilities for accurate disclosure, timely updates, and record retention to support FDA and sponsor inspection readiness. 

This SOP outlines sponsor responsibilities for collecting, reviewing, and reporting investigator financial disclosures under 21 CFR Part 54. It ensures that sponsors establish consistent processes for documentation, implement risk assessments when financial interests exist, and submit required FDA Forms 3454/3455 as part of marketing applications. 

A standardized tool for sponsors to collect required financial interest information from all investigators, in alignment with 21 CFR Part 54. Supports accurate certification, ensures consistency across sites, and provides documentation for FDA submission on Forms 3454/3455. 

This SOP outlines Sponsor-Investigator responsibilities for collecting, reviewing, and reporting investigator financial disclosures under 21 CFR Part 54. It ensures that sponsors establish consistent processes for documentation, implement risk assessments when financial interests exist, and submit required FDA Forms 3454/3455 as part of marketing applications. 

A standardized form that sponsor-investigators, investigators, and sub-investigators use to disclose financial interests, as required under 21 CFR Part 54. Includes certification and wet-ink signature fields to ensure accuracy, accountability, and FDA inspection readiness. 

Defines how sponsors ensure investigators, site staff, and vendors are qualified by education, training, and experience before trial duties are delegated. Covers collection of CVs, licenses, GCP certificates, and maintenance of training records for compliance with ICH E6(R3), 21 CFR 312.53(a)/812.43(a), EU CTR 536/2014, MDR 2017/745, and ISO 14155. 

Outlines how Sponsor-Investigators ensure themselves, sub-investigators, staff, and vendors are qualified and trained before delegated trial duties. Covers documentation of credentials, GCP training, delegation of authority, and training records, in line with ICH E6(R3), 21 CFR 312.53/812.43, EU CTR 536/2014, MDR 2017/745, and ISO 14155. 

Details how clinical sites ensure investigators, sub-investigators, and study staff are qualified and trained for delegated trial tasks. Includes documentation of CVs, licenses, GCP certificates, delegation of authority, and maintenance of training records, per ICH E6(R3), 21 CFR 312.53/812.43, EU CTR 536/2014, MDR 2017/745, and ISO 14155. 

A standardized form for recording staff training, including GCP, SOPs, protocol-specific instruction, and competency assessments. Ensures training is documented, signed, and retained in compliance with ICH E6(R3), 21 CFR 312.53/812.43, EU CTR 536/2014, MDR 2017/745, and ISO 14155.

A controlled template for documenting investigator and staff signatures, roles, and delegated study responsibilities. Provides traceability of who performed each trial task and when authority was delegated, ensuring compliance with ICH E6(R3), 21 CFR 312.53/812.43, EU CTR 536/2014, MDR 2017/745, and ISO 14155. 

A structured template to map study-specific training requirements by role, track completion, and ensure all staff maintain current qualifications. Supports compliance with ICH E6(R3), 21 CFR 312.53/812.43, EU CTR 536/2014, MDR 2017/745, and ISO 14155. 

A customizable template to define study-related roles, responsibilities, and required qualifications for investigators, staff, and vendors. Ensures role clarity and supports compliance with ICH E6(R3), 21 CFR 312.53/812.43, EU CTR 536/2014, MDR 2017/745, and ISO 14155.

A one-page template to capture essential qualifications, education, experience, licenses, and GCP training for investigators and study staff. Provides a streamlined alternative to full CVs, ensuring compliance with ICH E6(R3), 21 CFR 312.53/812.43, EU CTR 536/2014, MDR 2017/745, and ISO 14155.