ICH-GCP Clinical Trial Management

Evaluate compliance with ICH E6(R2) Good Clinical Practice guidelines for clinical trial design, conduct, monitoring, and documentation

BiotechHealthcareResearch22 minutes19 questions

1. IRB/IEC & Ethics

Has the trial been reviewed and approved by an IRB/IEC before initiation?*

ICH 3.1: Approval required before recruitment

Is continuing IRB/IEC approval maintained throughout the trial?*

ICH 3.3: Annual review or per IRB requirements

2. Investigator Responsibilities

Are investigators qualified with documented CVs, medical licenses, and GCP training?*

ICH 4.1: Investigator qualifications and experience

Do investigators maintain adequate staff and facilities to conduct the trial?*

ICH 4.1: Resources to safely conduct trial

Are serious adverse events reported per protocol and regulatory timelines?*

ICH 4.11: Immediate reporting of SAEs to sponsor and IRB

3. Informed Consent Process

Is informed consent obtained before any trial-specific procedures?*

ICH 4.8.3: Consent must precede trial participation

Do consent forms include all required elements per ICH-GCP?*

ICH 4.8.10: Purpose, procedures, risks, benefits, alternatives, confidentiality

Are subjects given adequate time and opportunity to ask questions?*

ICH 4.8.9: Non-coercive consent process

4. Essential Documents

Are all essential documents maintained per ICH E6 Section 8?*

Protocol, IB, consent forms, CVs, regulatory approvals, monitoring logs

Is the Investigator Site File (ISF) complete and audit-ready?*

ICH 8: All essential documents organized and readily available

Are protocol amendments approved by IRB before implementation?*

ICH 3.3.7: IRB approval required for amendments

5. Data Integrity & Source Documents

Are source documents available to verify all data entered in CRFs/eCRFs?*

ICH 4.9: Source documentation must support CRF data

Are data recorded contemporaneously, accurately, and legibly (ALCOA)?*

ICH 5.5.3: Original records must be attributable, legible, contemporaneous

Are corrections to source data documented with reasons, dates, and initials?*

ICH 5.5.3(d): No overwriting, single line through with explanation

Do electronic systems have audit trails capturing all data changes?*

ICH 5.5.3(e): Computerized systems must have audit trail capability

6. Monitoring & Quality Assurance

Is a risk-based monitoring plan implemented with documented monitoring visits?*

ICH 5.18: Monitoring ensures compliance with GCP, protocol, regulations

Are monitoring visit reports documenting findings and CAPAs?*

ICH 5.18.6: Written report after each monitoring visit

Does the sponsor conduct audits independently of routine monitoring?*

ICH 5.19: Quality assurance audits separate from monitoring

Are deviations from protocol documented with explanations and CAPAs?*

ICH 4.5.3: Protocol deviations must be documented and addressed

Please answer all required questions to see your results