GCP inspection preparation under ICH E6 R3: the complete site guide
What regulatory inspectors look for in 2026, the most common ICH GCP findings, and a proven 7-step framework for GCP inspection preparation under ICH E6 R3 at any site, anywhere in the world
The notification arrives in your inbox: a regulatory authority, the FDA, the EMA, the MHRA, ANVISA, or a national competent authority, will inspect your clinical trial site within the next two to four weeks. For some teams, that notification triggers a well-rehearsed process. For others, it triggers panic.
The difference between those two responses is rarely luck. It is preparation, specifically the kind of systematic, ongoing GCP inspection preparation that transforms a site from a place where good work happens to a place where good work is demonstrably, documentably proven to have happened.
In 2026, GCP inspection preparation has a new reference framework: ICH E6 R3. The guideline, formally adopted by the ICH in January 2025 and in effect across the EU from July 23, 2025, introduces a meaningfully different set of expectations for investigators, sponsors, and CROs worldwide. GCP inspection preparation under ICH E6 R3 does not simply add new requirements on top of E6 R2; it restructures the underlying logic of what quality in a clinical trial means. Inspectors trained on the new standard are not just checking whether SOPs exist. They are asking whether quality was designed into the trial from the start, whether risks were identified and managed proportionally, and whether the data generated can be traced back to its source with complete confidence.
This guide gives you the complete picture for GCP inspection preparation under ICH E6 R3: what the guideline changed about inspection expectations; what inspectors look for at investigator sites globally; what the most common GCP findings are in 2025 and 2026, and the specific 7-step framework you can use to move your site from reactive to inspection-ready, whether you are based in the United States, the European Union, Latin America, or anywhere else clinical trials are conducted.
What is clinical data management?
Clinical data management (CDM) is the process of collecting, validating, cleaning, coding, and locking the data generated during a clinical trial to ensure it is accurate, complete, and ready for regulatory submission and statistical analysis. The field of clinical data management exists because the stakes in clinical trials are extraordinarily high. Data gathered from thousands of patients across dozens of sites must meet strict regulatory standards. A single inconsistency, an unreported adverse event, or a protocol deviation that goes uncaptured can compromise an entire study. Clinical data management is the system that prevents those failures from reaching the submitted record.
The importance of CDM has grown substantially with the shift toward electronic data collection. Today, most trials run on Electronic Data Capture (EDC) platforms rather than paper case report forms, generating enormous volumes of data that must be integrated from multiple sources: clinical sites, central laboratories, patient-reported outcome tools, imaging vendors, and wearable devices. Clinical data management teams oversee all of it.
The Society for Clinical Data Management (SCDM), the main professional body for CDM professionals, defines it through its Good Clinical Data Management Practices (GCDMP) guidelines, which outline the standards that govern the discipline globally. The GCDMP is the industry’s foundational standard document for CDM practice. These guidelines sit alongside the ICH E6(R3) Good Clinical Practice standard and FDA regulations such as 21 CFR Part 11, which governs electronic records and electronic signatures in clinical research.
What changed in GCP inspection preparation under ICH E6 R3
Understanding what inspectors will now look for begins with understanding what ICH E6 R3 changed about the framework they use to evaluate your site. GCP inspection preparation under ICH E6 R3 requires a fundamentally different mindset from preparation under the previous R2 standard.
The three most consequential shifts are as follows:
- From documentation compliance to quality culture. ICH E6 R2 was fundamentally a documentation standard. If your site files were complete, your consent forms were signed, and your deviations were recorded, you had a reasonable chance of a clean inspection. GCP inspection preparation under ICH E6 R3 goes further. Its Quality Management System (QMS) requirements ask whether your site has a systematic approach to identifying and managing risks to participant safety and data integrity. An inspector operating under R3 will not just ask to see your deviation log; they will ask how your team identified that those deviations were possible risks in the first place and what you did to prevent them.
- From 100% source data verification to proportional oversight. Sponsors monitoring your site under ICH E6 R3 use risk-based monitoring approaches that focus their attention on data and processes that matter most to participant safety and data integrity. GCP inspection preparation under ICH E6 R3 must address whether your site’s monitoring plan was proportionate to the trial’s actual risks, and whether your responses to monitoring findings were timely and adequate. A site that received repeated monitoring queries for the same issue without resolution is a higher inspection risk than one with occasional deviations that were thoroughly investigated and remediated.
- From paper documentation to data governance. GCP inspection preparation under ICH E6 R3 now includes preparing for inspectors who will specifically evaluate your site’s electronic systems, audit trails, and data lifecycle practices. Inspectors will evaluate whether your electronic systems have functioning audit trails, whether your staff understand what a source document is in the context of a hybrid paper-and-electronic trial, and whether your data entry, correction, and authorization practices meet the ALCOA+ standard.
For context on what these changes mean in practice, see our guide on the key changes between ICH GCP E6 R2 and R3 and our complete guide to what is Good Clinical Practice.
Who conducts GCP inspections globally, and what does GCP inspection preparation under ICH E6 R3 require for each authority?
GCP inspection preparation under ICH E6 R3 must account for the specific regulatory authority most likely to inspect your site, because each authority operates under its own inspection procedures while applying the same underlying ICH E6 R3 standard. Understanding who inspects your site is the foundation of any credible GCP inspection preparation plan.
FDA Division of Bioresearch Monitoring (BIMO) — United States. FDA BIMO inspections are the most extensively documented source of GCP inspection findings globally. FDA inspectors issue findings classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI). OAI findings can result in site data being excluded from a regulatory submission, directly affecting the sponsor’s NDA or BLA. GCP inspection preparation under ICH E6 R3 for FDA BIMO must specifically address 21 CFR Parts 50, 54, 56, and 312, in conjunction with the ICH E6 R3 standard.
EMA and national competent authorities — European Union. EMA GCP inspections may be triggered by the European Medicines Agency for centralized marketing authorization applications, or conducted by national competent authorities (ANSM in France, BfArM/PEI in Germany, AEMPS in Spain, AIFA in Italy, CBG-MEB in the Netherlands, SUKL in Czech Republic, and others) for nationally authorized trials. GCP inspection preparation under ICH E6 R3 in the EU must account for the combined requirements of ICH E6 R3, EU CTR 536/2014, and the applicable national competent authority’s specific inspection procedures.
MHRA — United Kingdom. Post-Brexit, MHRA GCP inspections operate under a UK-specific framework that has adopted ICH E6 R3 on a timeline aligned with the EMA. MHRA publishes detailed GCP inspection findings summaries that are among the most useful public resources for GCP inspection preparation.
ANVISA, COFEPRIS, ANMAT, INVIMA, ISP — Latin America. GCP inspection preparation under ICH E6 R3 in Latin America must account for the inspection programs of each country’s national health regulatory authority. ANVISA (Brazil) and COFEPRIS (Mexico) both conduct GCP inspections of investigator sites participating in clinical trials authorized in their jurisdictions. ANMAT (Argentina), INVIMA (Colombia), and ISP (Chile) have progressively strengthened their GCP inspection capabilities. All Latin American authorities apply ICH GCP standards as the baseline, meaning that GCP inspection preparation under ICH E6 R3 follows the same core framework regardless of which LATAM authority is inspecting.
Sponsor and CRO auditors. Sponsor audits and CRO quality audits form the first line of GCP inspection preparation, conducted before any regulatory authority visit. They are not legally binding but are the most powerful advance warning system a site has. A site that performs poorly on a sponsor audit should treat it as a direct predictor of what a regulatory inspection would find.
What GCP inspectors look for at investigator sites under ICH E6 R3
The areas that inspectors examine during a GCP inspection under ICH E6 R3 are consistent across regulatory authorities globally. GCP inspection preparation under ICH E6 R3 must systematically address all of the following.
Informed consent, the most common area of GCP inspection findings worldwide
Informed consent remains the single most frequently cited area in GCP inspection findings across FDA, EMA, MHRA, and LATAM regulatory authorities. GCP inspection preparation under ICH E6 R3 must specifically address the strengthened consent requirements introduced by R3, including timeliness of re-consent, the use of electronic consent, and the documentation of the consent process itself.
Inspectors will check whether informed consent was obtained before any study-related procedures were performed, whether the correct version of the ICF was used at the time of consent, whether all protocol amendments requiring re-consent were handled in a timely manner, and whether participants who lacked capacity or were in vulnerable situations were consented according to the additional protections required. The most common finding is consent obtained using an outdated ICF version. For the complete framework for understanding informed consent requirements, see our guide to informed consent in clinical trials.
Principal investigator oversight and delegation
ICH E6 R3 places significantly stronger emphasis on the PI’s personal accountability for trial conduct. GCP inspection preparation under ICH E6 R3 at the PI level means ensuring that the delegation log is current and complete, that every person performing delegated activities is named with their specific duties listed, that their qualifications match the tasks assigned, and that their ICH GCP training is current and documented.
A finding increasingly common under R3 is that a PI has delegated responsibilities to staff without documented training on the relevant task, or has added staff to the delegation log after they had already performed delegated activities. Both represent exactly the kind of oversight gap that GCP inspection preparation under ICH E6 R3 is designed to prevent. For the complete breakdown of PI obligations, see our principal investigator responsibilities guide.
Investigational product management and accountability
Investigational product handling is consistently among the top three areas of GCP inspection findings at investigator sites globally. GCP inspection preparation under ICH E6 R3 for IP management means verifying receipt documentation, temperature logs, dispensing records, participant accountability logs, return and destruction records, and the reconciliation between all of these before the inspector arrives.
Common findings include temperature monitoring log gaps, dispensing records that cannot be reconciled with participant visit records, and failure to notify the sponsor of temperature excursions. See our practical guide to temperature excursions and our investigational product accountability guide for the complete framework.
Trial master file and investigator site file completeness
The TMF/ISF is the documentary proof that your trial was conducted according to GCP. GCP inspection preparation under ICH E6 R3 must systematically verify the completeness of your ISF against the essential documents listed in ICH E6 R3 Annex 1, Appendix C, checking that all required documents are present, correct-versioned, legible, and properly dated. The most common filing finding is not that documents are missing entirely, but that the site’s version does not match what the sponsor’s TMF contains.
Adverse event identification, assessment, and reporting
Adverse event reporting is the area where GCP failures can have the most serious consequences for participant safety. GCP inspection preparation under ICH E6 R3 must include a review of whether your site has a systematic AE detection process, not just a passive recording process. Inspectors will evaluate whether SAEs were reported within the required 24-hour window and whether causality was assessed by a medically qualified individual. See our guide to adverse event reporting in clinical trials for the full reference framework.
Good Documentation Practice and data integrity
Under ICH E6 R3’s data governance framework, GCP inspection preparation must specifically include a review of your site’s documentation and data management practices against the ALCOA+ standard. See our Good Documentation Practice guide for a complete explanation of what each element requires. Specific findings increasingly common under R3 include audit trail activities not attributed to a specific user, backdated entries in source documents, correction fluid applied to source records, and electronic records modified without a documented rationale.
Ethics committee oversight and protocol compliance
GCP inspection preparation under ICH E6 R3 must verify that all protocol amendments were submitted to the IRB/IEC and approved before implementation, that the ethics committee was notified of SAEs and deviations within required timelines, and that any waivers or exceptions are documented in the TMF. For a thorough explanation of ethics committee requirements, see our guide to the role of ethics committees in clinical trials.
The 7-step GCP inspection preparation framework for ICH E6 R3 compliance
GCP inspection preparation under ICH E6 R3 is not a two-week sprint before an inspector arrives. It is a year-round operational discipline. The following framework describes the steps that consistently distinguish inspection-ready sites from those that struggle under scrutiny, applicable to sites in the US, EU, Latin America, and globally.
Step 1: Conduct a structured site self-inspection for GCP inspection preparation
The most effective GCP inspection preparation tool is a site self-inspection conducted with the same methodology a sponsor auditor or regulatory inspector would use. This means reviewing your ISF against the ICH E6 R3 essential document checklist, testing your team on the protocols and procedures they are following, and actively looking for the gaps that a real GCP inspection under ICH E6 R3 would find.
A structured self-inspection should cover all the areas discussed above: consent documentation, delegation log accuracy, IP accountability, TMF completeness, adverse event reporting timelines, and eDC data integrity. The goal is to find problems during normal operations before they accumulate into a pattern that an inspector would classify as a systemic GCP failure.
Your GCP-trained staff are your most valuable GCP inspection preparation resource. Ensuring that every team member responsible for a study-critical function has completed an accredited good clinical practice certification course is the foundation of this step.
Step 2: Maintain your delegation log in real time
The delegation log is the document inspectors spend the most time reviewing at the investigator site level, and it is one of the areas that most frequently yields findings in a GCP inspection under ICH E6 R3 because sites do not maintain it in real time. Every new team member must be added before they perform any delegated activity. Every change in role must be reflected immediately.
Under ICH E6 R3, the PI is personally accountable for ensuring every delegated activity is performed by someone qualified to perform it. An inspector conducting a GCP inspection under ICH E6 R3 will hold the PI responsible for delegation log entries that are incomplete, backdated, or inconsistent with what the site’s other records show actually happened.
Step 3: Establish a prospective consent version control system
GCP inspection preparation under ICH E6 R3 for consent management means verifying, before every participant visit, that the ICF in use is the currently approved version. Many sites implement a simple visual flag system — colored folder tabs, sticky notes, or eDC system reminders — to signal when a new protocol amendment has triggered an ICF update. The re-consent date and the staff member who obtained consent must be clearly documented in both the source record and the eDC.
Step 4: Implement a structured adverse event review at every participant visit
Do not rely on participants to volunteer all medically relevant events. GCP inspection preparation under ICH E6 R3 requires building a structured AE review into every visit: a systematic review of concomitant medications, intercurrent illnesses, hospitalizations, changes in clinical status, and laboratory trends. Document this review in your source notes every time. A source note reading “AE review conducted: no new events” is valuable documentation for an inspector reviewing whether your team was actively looking, not just passively recording.
Step 5: Apply ALCOA+ to every documentation activity
From the moment a team member joins a study, they should be trained to apply ALCOA+ principles to every source record entry. GCP inspection preparation under ICH E6 R3 means ensuring that all staff date and time every entry at the time it is made, never use correction fluid, use a single line through errors with initials and reason, and ensure every eDC user has their own individual login. Provide regular refresher training, particularly for new staff and after any monitoring finding related to documentation.
Step 6: Prepare a staff availability and communication plan for the inspection period
When a GCP inspection under ICH E6 R3 is announced, one of the most practical preparation steps is ensuring the right people are available. Inspectors typically want to interview the PI, the primary study coordinator, and the pharmacist or designee responsible for investigational product management. Develop a communication plan: who is the inspection coordinator, who will accompany the inspector during records review, who has read-only access to electronic systems, and who is responsible for retrieving documents. Establish a daily debrief practice during the inspection to identify and address emerging concerns before the final closeout meeting.
Step 7: Know your protocol deeply and ensure your team does too
Many GCP inspection findings under ICH E6 R3 arise not from deliberate non-compliance but from staff who did not know what the protocol required in a specific situation. Every active protocol should be the subject of a documented study team training at site initiation, repeated whenever a significant amendment is implemented. Keep a log of these training sessions in your ISF. This document shows an inspector that your team was systematically prepared to implement the protocol correctly — evidence that is directly relevant to your GCP inspection preparation under ICH E6 R3.
GCP inspection preparation under ICH E6 R3: a global regulatory perspective
GCP inspection preparation under ICH E6 R3 is required regardless of where your site is located, because ICH E6 R3 is an international standard adopted by all major regulatory authorities. However, the specific procedural requirements and inspection approach vary meaningfully by region, and a complete GCP inspection preparation plan must reflect the regulatory environment in which your site operates.
GCP inspection preparation under ICH E6 R3 in Europe
In the European Union and United Kingdom, GCP inspection preparation under ICH E6 R3 must account for the combined requirements of the ICH guideline and EU CTR 536/2014. EU inspections may be conducted by the EMA for centrally authorized products or by national competent authorities for nationally authorized or ongoing trials. The EMA publishes an annual GCP inspection findings report that is one of the most useful reference documents for European sites undertaking GCP inspection preparation.
Key EU-specific elements of GCP inspection preparation under ICH E6 R3 include: familiarity with the CTIS (Clinical Trials Information System), the centralized EU portal through which all trial authorizations and amendments are processed; compliance with national data protection requirements under GDPR alongside the ICH data governance framework; and ensuring that the trial’s ethical review was conducted by a properly constituted ethics committee under the EU CTR requirements, not just ICH E6 R3’s IEC standards.
In the UK, MHRA GCP inspection preparation requires adherence to the UK Clinical Trials Regulations (SI 2004/1031 as amended), which have been updated to reflect ICH E6 R3. MHRA inspection findings are publicly available and provide a rich source of learning for GCP inspection preparation.
GCP inspection preparation under ICH E6 R3 in Latin America
GCP inspection preparation under ICH E6 R3 in Latin America requires understanding both the ICH framework and the specific national regulatory inspection program of each country in which your site is operating.
Brazil (ANVISA): ANVISA conducts GCP inspections of investigator sites participating in clinical trials registered in its national database. GCP inspection preparation for ANVISA inspections follows the same ICH E6 R3 framework but must additionally address ANVISA’s specific documentation requirements and the Portuguese-language regulatory submission standards. ANVISA’s inspection program has been strengthening progressively since 2018.
Mexico (COFEPRIS / COFEPRIS successor): GCP inspection preparation for COFEPRIS inspections in Mexico requires familiarity with NOM-012-SSA3 (the Mexican regulation governing clinical trials in human beings), which incorporates ICH GCP standards. Mexican inspectors apply both the national standard and ICH E6 R3 during site inspections.
Argentina (ANMAT): ANMAT conducts GCP inspections through its Dirección de Evaluación y Control de Productos de Uso Médico. GCP inspection preparation for ANMAT inspections must reflect the Disposición ANMAT 6677/2010 (and subsequent updates) alongside ICH E6 R3.
Colombia (INVIMA) and Chile (ISP): Both INVIMA and ISP have progressively aligned their clinical trial inspection frameworks with ICH GCP standards. GCP inspection preparation under ICH E6 R3 applies directly to sites operating under these authorities.
A key practical observation from our work training clinical research professionals across Latin America: GCP inspection preparation under ICH E6 R3 in LATAM is often more challenging than in the US or EU because sites may receive less sponsor-side support and monitoring, and may have fewer institutional resources for self-inspection programs. Investing in accredited ICH GCP E6 R3 training for all site staff is therefore even more important as a GCP inspection preparation foundation for LATAM sites than it is for sites in more heavily resourced markets.
The most common GCP inspection findings under ICH E6 R3 in 2025 and 2026
GCP inspection preparation under ICH E6 R3 should be prioritized based on the areas inspectors most frequently find issues. Based on published FDA BIMO inspection trend data, MHRA GCP inspection reports, EMA inspection findings summaries, and ANVISA inspection notices, the following categories consistently account for the majority of GCP findings:
Informed consent deficiencies remain the top category across all regulatory authorities globally: wrong ICF version, missing re-consent for protocol amendments, poorly documented consent process, and consent obtained by unqualified staff. Every element of GCP inspection preparation under ICH E6 R3 related to consent should target zero findings in this category.
Protocol deviations that were not identified by the site, not reported to the sponsor in a timely manner, or not appropriately investigated and remediated.
Inadequate investigator oversight: delegation log gaps, unqualified staff performing delegated activities, PI unavailability during critical trial periods.
Investigational product irregularities: temperature monitoring gaps, dispensing record discrepancies, accountability reconciliation failures.
Source data integrity issues: entries that are not contemporaneous, corrections made without documentation, eDC audit trail anomalies.
Inadequate adverse event reporting: events not identified, SAEs not reported within 24 hours, causality assessments not performed by a medically qualified individual.
Trial master file deficiencies: missing essential documents, wrong document versions, and documents present in the sponsor TMF but not in the site ISF.
These categories have remained largely stable for years. What changes under ICH E6 R3 is how inspectors contextualize findings within a QMS framework. A single-source data correction made without documentation is a documentation finding. A pattern of such corrections, together with unresolved monitoring queries, indicates a deficient quality management system, which carries greater regulatory weight and more significant consequences. GCP inspection preparation under ICH E6 R3 must be designed to eliminate systemic patterns, not just individual instances.
Conclusion
A GCP inspection under ICH E6 R3 is not the end of a process. It is the moment of accountability for everything your site has been doing, day by day, visit by visit, throughout the conduct of the trial. The sites that perform well are those that have treated GCP compliance not as a burden to document but as the actual standard by which they operate, and whose GCP inspection preparation under ICH E6 R3 reflects that throughout the year.
The ICH E6 R3 framework makes this expectation explicit in a way that R2 did not. Quality management is no longer something that happens after data is collected. It is built into the design of the trial, the training of the team, and the daily routines of the site. GCP inspection preparation under ICH E6 R3 simply makes the evidence of that visible.
If you are building or rebuilding your site’s inspection readiness in 2026, whether in Barcelona, Boston, São Paulo, or anywhere else where clinical trials are conducted, start with the foundation: ensure that every team member holds a current, accredited ICH GCP E6 R3 certification, understands what it means, and can demonstrate that understanding in the room with an inspector.
Are you ready to make your site inspection-ready in 2026?
PharmaEduCenter’s ICH GCP E6 R3 certification program gives your entire site team the knowledge they need for robust GCP inspection preparation under ICH E6 R3, enabling them to operate compliantly, document correctly, and perform with confidence under regulatory scrutiny, whether the inspector is from the FDA, EMA, MHRA, ANVISA, COFEPRIS, or any other competent authority.
Our training is fully online, self-paced, and accredited by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians (UK). Recognized under the TransCelerate GCP Training Mutual Recognition program. Available in English and Spanish. Can be completed in as few as 4 hours.
FAQ: GCP inspection preparation under ICH E6 R3
What is GCP inspection preparation under ICH E6 R3?
GCP inspection preparation under ICH E6 R3 is the systematic, year-round process of ensuring that an investigator site’s operations, documentation, training, and quality management practices fully comply with the ICH E6 R3 guideline and are ready to withstand scrutiny from a regulatory authority such as the FDA, EMA, MHRA, ANVISA, COFEPRIS, or any national competent authority. It encompasses the delegation log, informed consent records, investigational product accountability, trial master file completeness, adverse event reporting, data integrity, and ethics committee compliance.
How do I prepare for a GCP inspection under ICH E6 R3?
Effective GCP inspection preparation under ICH E6 R3 is ongoing rather than reactive. Year-round preparation includes maintaining a real-time delegation log, applying ALCOA+ documentation practices at every visit, conducting structured adverse event reviews, keeping your ISF current, ensuring all staff hold current ICH GCP E6 R3 certifications, and conducting regular self-inspections. When an inspection is formally announced, focus particularly on consent version control, IP accountability reconciliation, and protocol training completeness.
What are the most common GCP inspection findings under ICH E6 R3?
The most common findings in a GCP inspection under ICH E6 R3 across FDA, EMA, MHRA, and LATAM authorities are: informed consent deficiencies, protocol deviations not identified or reported, investigator oversight and delegation log gaps, investigational product management irregularities, source data integrity failures, inadequate adverse event reporting, and trial master file deficiencies. GCP inspection preparation under ICH E6 R3 must specifically address all of these areas.
How does ICH E6 R3 change GCP inspection preparation?
GCP inspection preparation under ICH E6 R3 differs from preparation under R2 in three key ways: inspectors now evaluate quality management systems rather than documentation alone; data governance and audit trail integrity are explicit inspection priorities; and the PI’s personal accountability for oversight of all delegated activities, including those performed by remote or third-party personnel, is specifically assessed. A site that was inspection-ready under R2 may not be fully prepared for a GCP inspection under ICH E6 R3 without specific updates to its QMS and data governance practices.
How long does a GCP inspection under ICH E6 R3 take?
A typical FDA BIMO investigator site inspection takes two to four days. EMA and MHRA inspections at multi-site studies can take longer. ANVISA inspections in Brazil and COFEPRIS inspections in Mexico follow their own inspection procedures but typically cover the same ICH E6 R3 compliance areas within one to three days. Sponsor audits, which form an important component of GCP inspection preparation under ICH E6 R3, are typically one to two days.
Does GCP inspection preparation under ICH E6 R3 apply in Latin America?
Yes. All Latin American regulatory authorities that oversee clinical trials, ANVISA (Brazil), COFEPRIS (Mexico), ANMAT (Argentina), INVIMA (Colombia), and ISP (Chile), require ICH GCP compliance as a baseline for clinical trial authorization and conduct. GCP inspection preparation under ICH E6 R3 follows the same core framework regardless of which Latin American authority is inspecting, with country-specific procedural requirements layered on top.
Does every person at my site need GCP training for a GCP inspection under ICH E6 R3?
Yes. Every person listed on the delegation log as performing or supervising any study-related activity must hold a current ICH GCP certification reflecting their responsibilities. Under ICH E6 R3, the PI is personally accountable for ensuring all delegated staff are adequately trained, and inspectors will verify this through the delegation log and training records. Current R3-compliant certification for all staff is the most fundamental element of GCP inspection preparation under ICH E6 R3.
What is the difference between a GCP audit and a GCP inspection under ICH E6 R3?
A GCP audit is conducted by the sponsor or CRO as part of quality assurance oversight. It does not carry regulatory authority but is the most valuable advance GCP inspection preparation tool a site has. A GCP inspection under ICH E6 R3 is conducted by a regulatory authority and carries legal authority. Findings from an inspection can result in regulatory action including exclusion of site data from a marketing application. Both should inform your ongoing GCP inspection preparation.e.
