The industry metrics paint a troubling picture of the current state of clinical trials recruitment and retention. With 37% of study sites not meeting their enrollment targets and 80% of studies failing to meet theirs, the industry faces a dire need for more effective strategies (source: 2024 WCG Data Intelligence).

Part of the problem can be attributed to the limited participation of investigators in clinical research and significant issues related to site staffing. Moreover, recruitment and retention difficulties are recognized as significant detractors, closely tied to a site’s resourcing levels. This not only disrupts timelines but can also inflate the cost of clinical trials substantially.

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Tackling the Site Identification and Feasibility Process

The process of site identification and feasibility is traditionally data-driven, relying heavily on existing relationships, in-house data, and historical experiences. Yet, a more nuanced approach is needed, incorporating a variety of data sources and reevaluating assumptions continually. For example, factors like the competitive landscape and protocol requirements must be considered, as they significantly impact a site’s recruitment and enrollment capabilities.

These activities are often treated as “one and done,” when, in reality, data from both internal and external sources constantly evolves. Feasibility, recruitment, and retention strategies must remain adaptable on an ongoing basis to maximize efficiency and study success.

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The Gap in Trust and Communication

A significant gap exists between sites and sponsors regarding trust in feasibility results. Many sites believe sponsors trust their feasibility responses, whereas a vast majority of sponsors showcase skepticism. This disconnect underscores the necessity for a dynamic approach to site identification and recruitment planning, continuously adapting to changes and reevaluating initial assumptions based on real-world challenges and situations.

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Rethinking Recruitment and Retention

Recruitment and retention should be viewed as a universal process with interconnected stages: identification, enrollment, retention, and documentation. Effective site selection, requires a deep understanding of a site’s capability to navigate through these stages, considering both internal contributions and the need for external referrals. Understanding the capacity of sites to manage external referrals and their geographical suitability for community outreach or provider networking is crucial.

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Resetting Expectations and Approaches

The industry must acknowledge the active nature of clinical trials and the inevitable changes and disruptions that occur. Open and clear communication channels between sites and sponsors, mutual trust, and a shared focus on trial and participant priorities are essential for navigating these changes effectively. By fostering a collaborative environment free from blame shifting, the industry can adapt more effectively to challenges in recruitment and retention, ensuring trials are completed safely, efficiently, and with integrity.

In conclusion, addressing feasibility, recruitment, and retention challenges in clinical trials requires a multifaceted approach, emphasizing flexibility, collaboration, and continuous reevaluation. By bridging the gap between sites and sponsors and adopting more dynamic strategies, the industry can move towards more effective and efficient clinical trial processes and successful outcomes.

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AUTHORS:

Crissy MacDonald, PhD
Vice President, Client Delivery
WCG

Seth Halvorson
General Manager, Site Solutions
WCG

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Strategic operations and organizational success start at the enterprise level and move into program and study level teams that implement strategies enabled by human and data intelligence. Accelerate your clinical research with a comprehensive suite of solutions that brings together integrated services to drive adjacent operational improvements and support industry needs across the study lifecycle.

Learn more and connect with an expert today!

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For more than a decade, the Avoca Quality Consortium (AQC) has emphasized the importance of driving change in the clinical trial execution process. This is predicated on our belief that organizations, working together, could realize change more effectively than organizations working in silos. Now we have the unique opportunity to augment our innovation initiatives to increase sustainability in clinical trials.

The healthcare sector is responsible for 5.2%^[1] of greenhouse gas (GHG) emissions, which is approximately 2.7 billion metric tons of CO₂. This is more than double that of global aviation (2.5%)^[2] and equivalent to the emissions of 720 coal-fired power plants.^[3] Moreover, in clinical trials, we contribute up to 100 million tons of CO₂ to that total, or about 27 coal-fired power plants which equals 19.5 million US homes’ electricity usage for one year. The World Health Organization (WHO) has noted that to effectively protect the health of populations, health systems have the double responsibility of building climate-related health resilience and reducing their own carbon footprint.^[4] As scientists, we must seek solutions to this crisis. We must prioritize the search for opportunities that lead to a healthier, cleaner, and safer environment rather than continuing current “business as usual” practices.

Clinical trialists have a unique opportunity to lead medical innovation while also acting as environmental stewards. In this series of blogs focused on sustainability in clinical trials, we hope to provide a landscape for tactical and specific actions you can take in your role in clinical trials. Health systems consist of organizations whose primary intent is to promote, restore, or maintain health.^[5] Whether you are a CRC, CRA, or CEO, and whether you work in a small CRO or a large Pharma company, you can contribute to increasing sustainability in clinical research to protect the health of current and future generations.

Some AQC members’ solutions include:

• The PPD clinical research business of Thermo Fisher Scientific, is composting leftover food at a Phase I clinic that enrolls over 2,000 patients and screens 8,000 annually and its Phase II-IV clinic uses Uber Green (hybrids and EV) wherever available for patient transportation.
• Bayer has been donating surplus lab kits from clinical trials in the US to Kits4Life since 2020, thereby diverting unused kits from landfill and repurposing them for humanitarian aid and to educational institutions. Expanding its work with Kits4Life outside of the US is ongoing.
• Novartis has smartly consolidated medication shipments to clinical sites, reaching a reduction of almost 50% or –42,000 shipments in 2022. Additionally, they have introduced reusable shipper boxes across almost all cool-chain clinical site shipments and have put policies in place to avoid the medication frontloading of clinical sites prior recruitment once feasible.

Consider this an opportunity for you to find out what actions your company is taking related to sustainability as well as specifically thinking about how you and your team can contribute to running clinical trials with a reduced environmental impact.

AQC members can view a recording of the sustainability initiative kickoff meeting in the Knowledge Center.

We look forward to you joining us as we continue the conversation into 2024.

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Learn more about becoming a member of the AQC to get involved!
Contact Us

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Authors:

Jürgen Wieland

Development Environmental Sustainability Lead; Novartis

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Carly Santer

Impact Officer; Bayer UK & Ireland

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Michael J. Cohen

Senior Director, Environmental Sustainability, Digital and Decentralized Solutions; PPD

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References:

[1] Romanello, M, et al., “The 2022 report of the Lancet Countdown on health and climate change: health at the mercy of fossil fuels”. Vol 400, Issue 10363, 5-11. Nov 2022.

[2] Hannah Ritchie, “Climate change and flying: what share of global CO2 emissions come from aviation?” 2020, Published online at OurWorldInData.org, https://ourworldindata.org/co2-emissions-from-aviation.

[3] US EPA, “Greenhouse Gas Equivalency Calculator,” www.epa.gov/energy/greenhouse-gas-equivalencies-calculator#results.

[4] WHO, “Operational framework for building climate resilient and low carbon health systems,” 9789240081888-eng.pdf (who.int).

[5] Sustainable Markets Initiative, “The Digital Solution for Sustainability in Clinical Research,” https://a.storyblok.com/f/109506/x/42119be232/smi-hstf-digital-health-whitepaper.pdf.

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Published: December 2023

The post Examining Sustainability in Clinical Research appeared first on Avoca, a WCG company.

The FDA recently released “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry,” which provides updated recommendations on how sponsors of clinical trials should approach risk-based monitoring activities. The FDA’s guidance emphasizes a risk-based approach to monitoring with monitoring efforts focused on areas with the highest potential risk to patient safety and data integrity. This approach allows sponsors to allocate their resources efficiently and effectively, ensuring that monitoring activities are tailored to the specific risks associated with each clinical trial.

The guidance outlines the principles of risk-based monitoring, including the identification of critical data and processes, the assessment of potential risks, the establishment of risk tolerance levels, and the development of a monitoring plan. Once critical data and processes are identified, sponsors should assess potential risks associated with these elements. Risks can arise from various sources, such as the study design, the investigational product, the study population, and the study conduct. Sponsors should evaluate the likelihood and impact of these risks on patient safety and data integrity to determine the level of monitoring required.

The guidance emphasizes the importance of establishing risk tolerance levels, which are predetermined thresholds that sponsors use to determine the need for monitoring. Risk tolerance levels should be based on the severity of the potential risk, the quality of the data being collected, and the robustness of the study processes. Based on the risk assessment and risk tolerance levels, sponsors should develop a monitoring plan tailored to the specific risks and needs of each trial and should include the rationale for the chosen monitoring approach, the frequency and intensity of monitoring, the responsibilities of the monitoring team, and the documentation requirements. The guidance also emphasizes the use of centralized monitoring techniques, such as statistical algorithms and data analytics, as part of the risk-based approach to monitoring. These techniques can help sponsors identify trends, patterns, and outliers in the data, which can be indicative of potential risks or data quality issues.

In conclusion, the FDA’s “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry” provides valuable recommendations for sponsors on how to optimize clinical trial monitoring. By adopting a risk-based approach, sponsors can efficiently allocate their resources to areas with the highest potential risk, ensuring patient safety and data integrity while improving the overall efficiency of clinical trial monitoring. By establishing risk tolerance levels, developing a tailored monitoring plan, and utilizing centralized monitoring techniques, sponsors can implement effective monitoring strategies that align with regulatory expectations and best practices in clinical research.

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Want to learn more? WCG Avoca Quality Consortium (AQC) members can visit the Risk-Based Quality Management – Quality by Design area of the Knowledge Center to access the many relevant tools available, including: 

• RBQM 04- Process for Establishing Critical to Quality (CTQ) Factors and Quality Tolerance Limits (QTLs),
• RBQM 01- Development of a Risk-Based Monitoring Plan, and
• RBQM 01a- Risk-Based Monitoring Plan Template.

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AQC members are invited to join the discussion at the next Risk-Based Quality Management CoLAB meeting by registering through the Meeting Calendar.

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Learn more about becoming a member of the AQC and access over 1,000 leading practices and metrics to stay up-to-date on industry guidances.
Contact Us

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Author:

Karen Harvey

Senior Director, Avoca Quality Consortium

WCG Avoca

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Published: May 2023

The post Understanding FDA’s Risk-Based Approach to Monitoring of Clinical Investigations appeared first on Avoca, a WCG company.

From January 31, 2023, use of CTIS for all initial clinical trial applications will be mandatory. CTIS was launched on January 31, 2022, starting the one-year transition time for all sponsors of clinical trials. During the first year, sponsors could choose whether to submit an initial clinical trial application in line with the Clinical Trial Directive (CTD) or under the Clinical Trial Regulation (CTR). The last date for sponsors to submit under CTD was January 30, 2023.

Many sponsors used the transition period to become familiar with CTIS. To date, more than 200 applications have been authorized under CTR. However, some users experienced problems with the new system. At an open event hosted by the European Medicines Agency (EMA) on January 20, 2023, Emer Cooke, the executive director of EMA, indicated that the first year was an opportunity for the agency to detect and resolve bugs to stabilize the core functionalities of the system and improve performance before the end of the transition year.

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Training and Support for Sponsors and Member States

There are 23 online modules available as well as various resources and tools e.g., a sandbox, monthly walk-in clinics, and Bitesize talks. They allow for sponsor question and answer sessions with practical guidance on CTIS and its functionalities. A Clinical Trials Highlights Newsletter is published every two months. Since December 2022, a weekly CTIS newsflash has been published in anticipation of the mandatory use of CTIS on January 31, 2023. All of these resources are available at Clinical Trials Information System: training and support | European Medicines Agency (europa.eu).

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Challenges

At the open event, in addition to the technical challenges encountered, both the sponsor representative and academia representative highlighted the following:

• The rigid deadlines for responding to Requests for Information (RFI) and the lack of notification that an RFI has been posted. Both recommended monitoring CTIS at least once daily during the application period.
• The lack of harmonization among member states resulting in the lapsing of trials due to unforeseen national requirements. For example, Part II documents for Greece need to include signed site agreements; Ireland and Germany did not accept the site suitability template because each country published a specific one to use; Hungary requested a protocol signature page for all investigators in an RFI. Note CTIS does not require signatures on protocols or CVs unless it is a national requirement. Annex 3 of the recently published CTR Q & A Version 6.3 lists the websites of member states where sponsors ‘can find important information to submit high quality Part II documents’ (i.e., the national requirements.) It is posted at EudraLex – Volume 10 (europa.eu)
• Part II RFIs were received before Part I had been approved resulting in additional work for both Member States and sponsors. The session chair indicated this should not have occurred and was a result of the steep learning curve that stakeholders are experiencing.
• Redaction takes time, especially during the 12-day RFI timeline.
• Difficulties encountered in cross referencing Investigational medicinal product dossier (IMPD) when the sponsor is not the product owner. A solution is in the works for this issue. The product owner will be able to submit the quality documentation directly to the member state concerned so confidentiality is maintained.

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Qualification of Vendors

When qualifying CROs for an EU study, it will be important to assess their knowledge of CTR and what experience they have gained in using CTIS during the transition period. Training records should be reviewed prior to granting access to CTIS.

All service providers should have a process in place for identifying and reporting potential serious breaches to the sponsor promptly. The sponsor will need to determine if the breach meets the definition according to Article 52; i.e., a Serious Breach of the regulation or of the version of the protocol applicable at the time of the breach. Reporting of the serious breach should be done through CTIS within 7 calendar days of the sponsor becoming aware of the breach [Guideline on reporting serious breaches (europa.eu)].

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Oversight of Vendors

There are up to 18 sponsor roles in CTIS. Each comes with a specific set of permissions. Examples of user personas are CTIS Submission Manager, Regulatory Project Manager, In-Country Specialist, etc. The personnel assigned to these roles could be at a CRO. However, oversight of the trial, including its submission and approval through CTIS, remains with the sponsor. It will be important for trial project managers at the sponsor to become familiar with navigating CTIS and overseeing vendors who have been provided access to the system and ensuring access is revoked when there is a change in staff or the trial has been completed.

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Qualification of Principal Investigators and Sites

Principal Investigators (PIs) should also have a process in place to ensure site staff are able to identify the occurrence of a (suspected) serious breach and that it is promptly reported to the sponsor or delegated party through the contacts provided. This may be a formal standard operating procedure or study specific guidance in the protocol. Documented training of the site’s staff and PI on this process should be stored in the trial master file (TMF).

Training of Principal Investigators and site personnel in the EU will need to address the following new requirements:

• Learning and applying new consent requirements
• Complying with 24-hour reporting requirement of Serious Adverse Events (SAEs)
• Working with sponsor on reporting of serious breach and Urgent Safety Measures (USM) via CTIS within specified timeframe.
• Being aware of document archiving requirements (25 years for trial documents; national law for patient files)
• Documented or certified training (GCP, CTR etc.).

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In February 2023, the WCG Avoca Quality Consortium (AQC) gathered to discuss their experiences with preparing for and/or actively using CTIS during the transition year. AQC members can view this session in the Knowledge Center webinar archive, as well as register for upcoming meetings on the event calendar. Also, 34 Knowledge Center documents have been revised to support compliance with the updated EU 536/2014 Clinical Trial Regulation.

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Learn more about the AQC and how WCG Avoca can conduct a gap analysis of your processes to ensure they comply with CTR requirements.
Contact Us

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Author:

Brigid Flanagan, BA, RN, CCRC, MSB

Senior Consultant

WCG Avoca

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Published: March 2023

The post Mandatory Use of Clinical Trial Information System (CTIS) for Initial Clinical Trial Applications in the EU appeared first on Avoca, a WCG company.

The FDA recently updated their Good Clinical Practice Inquiries and Responses 2017-2021. This Q&A publication is based on the questions submitted to the FDA via gcpquestions@fda.hhs.gov.

In response to multiple questions related to PI oversight of home nursing activities, the FDA responses have referenced the Guidance for Industry: Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects which states that the investigator should ensure that any individual to whom a task is delegated is qualified by education, training, and experience to perform the delegated task. The guidance (Section III.A.4.) further states that the investigator is responsible for supervising the study tasks performed by this staff, even though they are not in his/her direct employ during the conduct of the study. The reference to the guidance makes clear the FDA expectation of PI oversight for home nursing activities.

There can be significant challenges associated with PI oversight of home nursing staff, especially if the home nursing company is contracted directly by the sponsor. In the responses noted above, the FDA recommended that the investigator discuss the study with the sponsor to ensure an understanding of the role of the home nursing service and the expectations of the investigator for supervising the conduct of the study, delegating study-related tasks, ensuring adequate training, and oversight of the study. The investigator and the sponsor should agree on a plan to help the investigator meet his/her responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations. The plan should be documented to allow the PI to evidence the oversight in case of inspection – if it wasn’t documented, was it done?

WCG Avoca Quality Consortium (AQC) Members have access to resources to support documentation of PI oversight in the Site Quality section of the Knowledge Center, including SQMS 03 – Proactive Quality Framework for Sites Investigator Responsibilities.

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Learn more about becoming a Member of the AQC and access over 1,000 leading practices and metrics to stay up-to-date on industry guidances.
Contact Us

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Author:

Karen Harvey

Senior Director, Avoca Quality Consortium

WCG Avoca

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Published: March 2023

The post What is the Expectation for PI Oversight of Home Nursing Activities? appeared first on Avoca, a WCG company.

The updates to the Bioresearch Monitoring (BIMO) program for Sponsors and Contract Research Organizations released in September 2021 shed light on FDA’s current thinking on important topics such as the selection and monitoring of clinical investigators and outsourced services. The BIMO program is a comprehensive FDA-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research.

BIMO program objectives are “to protect the rights, safety and welfare of human research subjects involved in FDA-regulated clinical studies; to verify the accuracy and reliability of study data submitted to FDA in support of research or marketing applications; and to assess compliance with statutory requirements and FDA’s regulations.” While the Compliance program manuals were created to provide standardized instructions for the conduct of inspections to be followed by field inspectors, in the spirit of transparency, this information is this information is publicly available. This essentially allows Sponsors and CROs the opportunity to ‘see the test’ before taking it.

In July of 2022, the WCG Avoca Quality Consortium (AQC) presented a robust overview of the updates to the BIMO program for sponsors and contract research organizations, and the workshop recording is available for replay. How have these updates changed today’s inspection experiences? Recent feedback from AQC Members’ inspection experiences reflect the new language in the BIMO guide, such as requests for all versions of the written agreements, increased focus on data flow, and request/review of meeting minutes including action item status.

In January of 2023, AQC Members gathered to discuss learnings and strategies to leverage experiences to support inspection readiness activities. AQC Members can view this session in the Knowledge Center webinar archive, as well as register for upcoming meetings on the event calendar. Additional BIMO information is available in the following member resource: INSPA 02 – US FDA Inspection Readiness Agency Resource.

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Learn more about becoming a Member of the AQC and access over 1,000 leading practices and metrics to stay up-to-date on industry guidances.
Contact Us

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Author:

Karen Harvey

Senior Director, Avoca Quality Consortium

WCG Avoca

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Published: February 2023

The post BIMO in Action: AQC Members Share Insights from Recent Inspection Experiences appeared first on Avoca, a WCG company.

Quality is a primary consideration in the design, planning, conduct, analysis, and reporting of clinical studies and a necessary component of clinical development programs. [ICH E8 (R1)]. Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control and is based on sound science and quality risk management.

Incorporating Quality by Design (QbD) leading practices into the Provider Qualification process is extremely important to proactively drive greater efficiency and risk management as well as continuous improvement. However, there are several challenges to overcome when implementing QbD leading practices. Many of the challenges can be anticipated and proactively addressed with a well thought out and planned approach. For example, the amount of information available to us now can help identify Provider experience and expertise and measure potential risks with Providers; however, the abundance of such can be daunting. More isn’t always better. Therefore, identifying elements that are most important to your clinical trials and those which have the greatest potential impact for improving quality in your Provider Qualification process are crucial to effectively incorporating QbD.

QbD practices should be woven into the Provider Selection and Qualification process in the simplest and most impactful way. It is important to keep in mind that easily incorporated and easily evaluated measures will be the most beneficial to your organization. 

Traditionally, Provider Qualifications have been carried out through a risk assessment process, but QbD measures have not always been incorporated into the process, and neither has evaluating a Provider organization’s success and experience in incorporating QbD practices into their own services. To move from a traditional Provider risk assessment to a more risk-based QbD approach, companies must adopt a Provider risk assessment process which incorporates not only review of traditional Provider capabilities, but also evaluates the Provider’s adoption and experience with QbD and risk-based quality management practices. This can be achieved by thoughtful planning in advance and by implementing questions that are targeted.

The following table provides some example questions that align with several of the risk-based categories set forth by ICH E6 (R2):

Identifying potential risks by asking questions which address what could go wrong, why or how that could go wrong, what the consequences are if failure occurs, and what mitigation steps can be implemented in advance to avoid the failure or to address the potential risk before it becomes an issue, will help build quality into your assessment process. (AQC Members can access Process Tool 04h – QbD Leading Practices When Outsourcing in the Knowledge Center.)

In addition, evaluating each risk by assigning a severity rating, a rating for the likelihood of occurrence and the detectability of the failure will also help improve the quality of your Provider assessments. (AQC Members can access PQUAL 01b – Core Scorecard Template in the Knowledge Center.)

Incorporating QbD and risk-based methodologies into Provider Qualification is no small task but the benefits are multifold, QbD:

• Ensures your organization is compliant with current regulatory expectations
• Improves collaboration with Providers
• Identifies potential risks early in the process so they can be mitigated before they become issues
• Helps Providers identify and address potentially unknown risks and plan for future improvements
• Reduces redundancies through use of standardized and consistent templates and risk scoring tools
• Helps to shorten study timelines by reducing the number of unexpected issues

It is important to keep in mind that regulatory authorities continue to emphasize and encourage the use of QbD and risk-based approaches in the qualification and oversight of clinical service Providers, as an industry, adoption of these methodologies across our clinical trials is expected.

By implementing these practices into your qualification and oversight processes you will gain operational success, higher quality trials, shorter timelines, and greater efficiency across your organization.

Members of the WCG Avoca Quality Consortium (AQC) have access to leading practice documents and metrics that can help you utilize the described approach. These tools are among a total of over 500 leading practice documents and 1,000 metrics assets in the AQC Knowledge Center.

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Learn more about becoming a Member of the AQC and/or how our consulting services can help your company implement QbD processes into your Provider Qualification and Oversight Practices.
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The post Incorporating QbD into the Provider Qualification Process appeared first on Avoca, a WCG company.

The Trial Master File (TMF/eTMF) is essential in telling the story of how your organization conducted your clinical trial activities, including how you ensured data integrity, patient safety, and compliance throughout the conduct of your trial. The TMF is a critical component of the trial process and is typically a primary area of focus for a regulatory inspector during an inspection.

We all know that “If it’s not documented, it didn’t happen,” and we can take that a step further when considering your TMF. If a document is not filed appropriately, it can be considered not done during an inspection. An inspector will not likely go hunting for it and your organization may not be given the opportunity to locate it either.

All regulatory bodies focus on the TMF during an inspection but there is special emphasis given by MHRA, as the basis of their inspection is the TMF.

WCG Avoca has collected information regarding critical and major findings by MHRA for the years April 2018 – April 2019 (2018-2019) and April 2017 – April 2018 (2017-2018) and found that 15% or more of the major findings were in the following categories:

• Pharmacovigilance
• Record Keeping and Essential Documents/TMF

The importance of the TMF cannot be understated.

It is always best to build out a quality TMF/eTMF from the onset, but it is equally important to consistently conduct reviews of your TMF. Reviewing your TMF is an essential part of proactively ensuring an on-going state of inspection readiness. In addition, your organization should be implementing ALCOA-C principles for clinical trial documentation which require that the Trial Master File be attributable, legible, contemporaneous, original, accurate, and complete.

At the end of the day there is a person behind the documents, and you are telling the story of how your organization ensured that person’s safety and the integrity of the data they helped provide.

In our industry we must always be inspection ready but make no mistake, if your TMF isn’t inspection ready then neither is your organization. Failure to make your TMF a top priority can lead to delays in clinical trial completion, it can add unnecessary stress to personnel during an inspection, and ultimately it could impede your organization from bringing your drug to market.

The FDA recently stated that the COVID-19 pandemic resulted in the need to be flexible and evolve, but “the importance of protecting patients and adequate documentation remain mission critical to the agency.”

So, what do you do if you know or suspect that your TMF might need some attention? When is the last time you conducted a periodic review of your TMF?

Periodic reviews should be documented and include information on any identified deficiencies along with how and when those deficiencies were addressed. 

Areas of focus for your TMF review generally include the following:

• ICH E6 Essential Documents
• Organization and Personnel
• Quality Management
• External Service Provider
• IT Systems
• Clinical Study Management
• Investigator Sites
• Monitoring
• Pharmacovigilance
• Regulatory Affairs
• IMP Management
• Labs
• Biostatistics
• Data Management 

Once you know where the issues lie within your TMF/eTMF, you can get to work on addressing the gaps.

In alignment with Regulatory Agency recommendations for having a complete, correct, current, and accessible TMF for Inspection Readiness, WCG Avoca has developed an Inspection Readiness Dashboard. The dashboard allows users to capture inspection activities at various timepoints, specify relative risk levels, and indicate the status of ICH E6 essential documents (e.g., complete, filed, missing). WCG Avoca Quality Consortium (AQC) Members can access the Inspection Readiness Dashboard in the Knowledge Center.

This is just one of many risk-based tools available to AQC Members in our Knowledge Center, which consists of over 1,000 regulatory compliant leading practice tools and templates customizable to their organization to be inspection ready. View the current catalog of tools.

In addition to the tools available to assist with inspection readiness, WCG Avoca has consulting services which can conduct periodic TMF reviews for you while completing the Inspection Readiness grid in order to understand your current state of inspection preparedness.

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Learn more about AQC Member benefits or consulting services for your organization to ensure your TMF is inspection-ready.
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A foundational element for any Clinical Quality Management System (CQMS) is adequate policies and procedures that provide framework for quality and compliance in clinical trial conduct. Clinical trial sites are at the intersection of action and oftentimes inherit burden they may not be equipped or resourced to handle. In Lean principles “going to Gemba” means going to “the real place” where activity is conducted. Clinical research sites are Gemba and sites are tasked with the critical responsibility of implementing trials, complex in design, within various infrastructures. ICH E8 (R1) calls for engagement of stakeholders in trial design and clinical research sites are a vital element to success. Site voice is essential to continuous improvement efforts that focus on implementation of protocol activities and participant involvement.

In support of clinical research sites, the WCG Avoca Quality Consortium (AQC) is adding 6 new foundational Site SOPs to our comprehensive Member-only Knowledge Center of 1,000+ leading practice documents and tools. These 6 SOPs are accompanied by 85+ additional related resources and templates that are referenced within each SOP to facilitate operational adoption.

WCG Avoca SOPs have been established for the following foundational elements of conduct:

1. General Administration
   This SOP includes details pertaining to responsibilities for Good Clinical Practice, document development/change control, ensuring qualified site personnel, contract processes, and record management and retention.
2. Regulatory Affairs
   This SOP includes details pertaining to essential documents, submissions to ethics committees, reporting requirements, and conflicts of interest.
3. Project Management
   This SOP includes details pertaining to assessment of study feasibility, start-up activities, investigational product management, source documentation, monitoring visits, protocol compliance, and study completion.
4. Trial Participant Management
   This SOP includes details pertaining to recruitment, screening, retention, informed consent, eligibility and enrollment, protection of confidential information, visit activity and assessments, and adverse events.
5. Data Management
   This SOP includes details pertaining to use of electronic systems and clinical data management.
6. Quality Assurance
   This SOP includes details pertaining to internal audit activity and regulatory authority inspections.

The addition of these resources to the AQC Knowledge Center provides necessary support to assist our site partners in developing and maintaining procedures that align with current regulations and guidances. With our mission as our underpinning, WCG is dedicated to supporting all stakeholders of the clinical trials industry in the relentless pursuit of finding answers! AQC Members can access these new resources within the Site Quality section of the Knowledge Center.

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Learn more about becoming a Member of the AQC and access over 1,000 leading practices and metrics, including a comprehensive Quality Agreement template.
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Author:

Trevor J. Cole, BHS, MBA, CCRC, PMP, RN

Associate Director, Client Delivery

WCG Avoca

The post The Gemba that is Clinical Research Sites appeared first on Avoca, a WCG company.