SOP Library

Quality & Document Control

Internal Audits & Inspection Readiness

To describe the internal audit programme and the site's state of continuous readiness for sponsor audits and regulatory inspections, including FDA Bioresearch Monitoring (BIMO) inspections.

Acknowledged70% (42/60)

Effective Aug 12, 2025 · review by Nov 12, 2026 · ~11 min read

TRN-001

Effectivev5.0

Training & Qualification of Research Personnel

Training

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.

Acknowledged63% (47/75)

Effective Feb 02, 2026 · review by Feb 02, 2027 · ~13 min read

REG-001

Effectivev3.2

Regulatory Binder / Essential Documents Maintenance

Regulatory & Ethics

To define the content, organisation, maintenance and quality control of the regulatory binder (trial master file at site level) so that essential documents are complete, current and available for monitoring, audit and inspection.

Acknowledged63% (36/57)

Effective Oct 06, 2025 · review by Oct 06, 2026 · ~12 min read

REG-002

Effectivev2.0

IRB Submissions, Amendments & Continuing Review

Regulatory & Ethics

To describe how Quillbrook prepares, submits and tracks Institutional Review Board submissions, including initial review, amendments, continuing review, reportable events and study closure.

Acknowledged64% (29/45)

Effective Jun 23, 2025 · review by Oct 23, 2026 · ~10 min read

SUB-001

Effectivev4.1

Informed Consent Process & Documentation

Subject Protection

To ensure that informed consent is obtained and documented from every research subject, or the subject's legally authorized representative, before any study procedure is performed, and that consent remains an ongoing process throughout participation.

Acknowledged60% (27/45)

Effective Mar 09, 2026 · review by Mar 09, 2027 · ~14 min read

SUB-002

Effectivev2.2

Subject Recruitment, Pre-Screening, Screening & Enrollment

Subject Protection

To describe ethical, compliant recruitment and the sequence of pre-screening, screening and enrolment activities, so that eligibility is established and documented before a subject receives investigational product.

Acknowledged67% (26/39)

Effective Sep 15, 2025 · review by Sep 15, 2026 · ~10 min read

CON-001

Effectivev5.1

Adverse Event & Serious Adverse Event Reporting

To define how adverse events and serious adverse events are identified, assessed, documented and reported to the sponsor and the IRB, so that subject safety is protected and regulatory reporting obligations are met.

Acknowledged65% (33/51)

Effective Apr 13, 2026 · review by Apr 13, 2027 · ~13 min read

CON-002

Protocol Deviations & Violations

To define identification, classification, documentation, reporting and prevention of protocol deviations and violations.

Acknowledged63% (39/62)

Effective Jul 07, 2025 · review by Oct 07, 2026 · ~9 min read

CON-003

Effectivev4.0

Investigational Product Receipt, Storage, Accountability & Destruction

To ensure investigational product is received, stored, prepared, dispensed, reconciled and returned or destroyed under controlled conditions with complete accountability, including management of temperature excursions.

Acknowledged39% (15/38)

Effective Jan 26, 2026 · review by Jan 26, 2027 · ~12 min read

CON-004

Effectivev3.1

Biological Specimen Collection, Processing & Shipping

To ensure biological specimens are collected, labelled, processed, stored and shipped so that sample integrity, subject privacy and dangerous goods regulations are all satisfied.

Acknowledged60% (24/40)

Effective Dec 01, 2025 · review by Dec 01, 2026 · ~12 min read

CON-005

Effectivev2.0

Sponsor Monitoring Visits & Query Resolution

To define preparation for, conduct of and follow-up to sponsor and contract research organisation monitoring visits, including timely resolution of data queries and action items.

Acknowledged58% (31/53)

Effective May 05, 2025 · review by Nov 05, 2026 · ~9 min read

DAT-001

Source Documentation & ALCOA+ Principles

Data Integrity

To define the standards for creating, correcting and maintaining source documentation so that study data are attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available.

Acknowledged74% (42/57)

Effective Oct 20, 2025 · review by Oct 20, 2026 · ~10 min read

DAT-002

Electronic Records & Electronic Signatures (21 CFR Part 11)

Data Integrity

To ensure electronic records and electronic signatures used at Quillbrook are trustworthy, reliable and equivalent to paper records and handwritten signatures, in accordance with 21 CFR Part 11.

Acknowledged51% (38/75)

Effective Feb 16, 2026 · review by Feb 16, 2027 · ~13 min read

DAT-003

Effectivev2.1

Study Close-Out & Record Retention

Data Integrity

To define the activities required to close a study at the site and the retention, storage and destruction of study records afterwards.

Acknowledged59% (36/61)

Effective Apr 14, 2025 · review by Oct 14, 2026 · ~9 min read

HIP-001

Effectivev4.0

HIPAA Privacy Rule in Research: Uses & Disclosures of PHI

To define the permitted pathways for using and disclosing protected health information for research at Quillbrook, and to ensure every use is authorised, limited to the minimum necessary, and documented.

Acknowledged63% (47/75)

Effective Mar 02, 2026 · review by Mar 02, 2027 · ~15 min read

HIP-002

Effectivev3.1

HIPAA Security Rule Safeguards

To establish the administrative, physical and technical safeguards that protect the confidentiality, integrity and availability of electronic protected health information at Quillbrook.

Acknowledged65% (49/75)

Effective Jan 12, 2026 · review by Jan 12, 2027 · ~14 min read

HIP-003

Privacy & Security Incident Response and Breach Notification

To ensure privacy and security incidents are reported, contained, assessed and, where they constitute a breach of unsecured protected health information, notified to affected individuals, the Secretary of Health and Human Services and the media within the required timeframes.

Acknowledged68% (51/75)

Effective Feb 23, 2026 · review by Feb 23, 2027 · ~13 min read

HIP-004

Effectivev2.2

Individual Rights: Access, Amendment & Accounting of Disclosures