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#14 Practical RWE – Documentation: 1572s

#14 Practical RWE – Documentation: 1572s

 

It’s a question that still (frustratingly) comes up in the context of non-interventional studies conducted in Europe…”Do I need a signed 1572 from my investigators?”

Form FDA 1572, also known as the “Statement of Investigator,” is a document that is specifically used in the context of clinical trials conducted under the regulations of the United States Food and Drug Administration (FDA). This form is a contract between the principal investigator and the FDA, indicating the investigator’s commitment to conduct the trial in accordance with FDA regulations.

FDA 1572 forms (1572s) are not applicable to clinical trials or non-interventional studies conducted in Europe.

In 2019, the Spanish Competent Authority (AEMPS) joined the position of other European Agencies (Denmark, Germany, Norway, Sweden and Switzerland) by releasing a statement, announcing that the FDA 1572 forms should not be signed by Spanish investigators. The main reason being that 21 CFR 312 is not the regulation in force in EU/Spain:

“The investigators in Spain cannot commit to comply with the established requirements by FDA 1572 form. A clinical trial carried out in Spain, the rest of EU, and EEE must not follow any third-country’s legislation. The clinical trial must be carried out in accordance with Spanish legislation that transposes EU directives 2001/20/EC, 2001/83/EC and 2005/28/EC, and EU regulation no. 536/2014 (once this will be in force)… It should be noted that The inspectors of clinical trials in Spain will consider the signature of FDA 1572 form as a serious finding applicable to the Sponsor of the clinical trial and to the Principal Investigator too as s/he will be the signatories of this form.”

Source: https://www.chcuk.co.uk/aemps-statement-regarding-use-of-fda-1572-forms/

European clinical trials are governed by different regulations and guidelines to those in the USA, primarily the EU Clinical Trials Regulation (EU) No 536/2014, and the ICH Good Clinical Practice (GCP) guidelines.

For non-interventional studies in Europe, the relevant local and EU regulations and guidelines apply, and the FDA 1572 form is NOT relevant or required.

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#14 Practical RWE – Documentation: 1572s2024-02-01T17:14:31+00:00

#13 Practical RWE – Documentation: Trial Master File vs Study Master File

#1 Practical RWE – The Importance of Harmonised Definitions (RWR, RWD, RWE)

 

Definitions are crucial in the context of real-world research (RWR), real-world data (RWD), and real-world evidence (RWE) for several reasons:

  1. Clarity and Precision: In research, clear definitions ensure that everyone understands exactly what is being discussed. This is particularly important in RWD and RWE, where the data comes from a variety of sources and might be interpreted in different ways.
  2. Consistency: Definitions help maintain consistency across studies. In the realms of RWD and RWE, where studies often use data collected for other purposes, having standard definitions allows for more reliable comparisons and aggregations of data.
  3. Data Quality: Good definitions help ensure high-quality data. In real-world research, where data is not collected in controlled experimental settings (e.g., randomised controlled trials), clear definitions are essential for filtering and processing data effectively.
  4. Regulatory Compliance: In many fields, particularly in healthcare and pharmaceuticals, RWE is used to support regulatory decisions. Precise definitions are critical to meet the regulatory standards for evidence.
  5. Interdisciplinary Communication: RWD and RWE often involve collaboration across various disciplines. Clear definitions facilitate better communication and understanding among diverse groups of researchers, clinicians, policymakers, and other stakeholders.
  6. Replicability and Scalability: Well-defined concepts and methods enable other researchers to replicate studies or scale up research projects. This is vital for the advancement of science and policy-making.
  7. Data Integration: In real-world research, data often comes from multiple sources. Consistent definitions allow for more effective integration and analysis of this heterogeneous data.
  8. Targeted Interventions and Policies: In applied research, such as public health or market research, clear definitions help in designing more effective interventions and policies, as they allow for a precise understanding of the phenomena being addressed.

In essence, definitions lay the groundwork for accurate, consistent, and meaningful research, especially in areas where the data and its sources are as diverse and complex as in RWD and RWE.

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#13 Practical RWE – Documentation: Trial Master File vs Study Master File2024-02-01T16:04:58+00:00

#12 Practical RWE – Training: Study Team Training

#12 Practical RWE – Training: Study Team Training

 

Study team training is crucial in both Real-World Evidence (RWE) studies and clinical trials, but the importance and focus of the training can vary significantly due to the different natures and objectives of these two types of studies.

  1. Nature of Data Collection:

– In clinical trials, data is collected under controlled conditions with predefined protocols. Training emphasizes adherence to these protocols, ensuring uniformity and minimizing bias.

– RWE studies, on the other hand, use data from sources like electronic health records, insurance claims, or patient registries. Training here focuses on understanding these data sources, identifying relevant data, and ensuring its quality and integrity.

  1. Regulatory Compliance and Guidelines:

– Clinical trials are highly regulated with strict guidelines for conduct. Training ensures compliance with these regulations, including patient safety and reporting requirements.

– RWE studies, while still subject to regulatory considerations, have different compliance requirements. Training helps in understanding these nuances and applying appropriate methodologies.

  1. Study Design and Methodology:

– Training for clinical trials includes detailed study design, placebo controls, blinding methods, and other experimental procedures.

– In RWE studies, training focuses more on observational study designs, statistical methods for handling real-world data, and techniques for reducing bias in non-randomized settings.

  1. Patient Interaction and Consent:

– Clinical trials usually require direct patient interaction, informed consent, and continuous monitoring. Training includes effective communication with participants and managing adverse events.

– RWE studies often use existing data where direct patient interaction is minimal. Training focuses more on data privacy, patient consent in the context of data use, and ethical considerations.

  1. Data Analysis and Interpretation:

– Clinical trial training includes specific methods for analyzing clinical data and interpreting results according to clinical endpoints.

– In RWE studies, training often covers a broader range of data analysis skills, including dealing with large datasets, diverse data types, handling missing data, and applying real-world evidence to clinical or policy decisions.

  1. Collaboration and Multidisciplinary Understanding:

– Both study types require understanding roles across disciplines. However, RWE studies often involve more diverse teams (e.g., data scientists, health economists, healthcare providers, policy makers) and thus require training in effective cross-disciplinary collaboration.

In summary, while study team training is fundamental in both clinical trials and RWE studies for ensuring quality, compliance, and reliability of results, the specific focus of the training differs to cater to the unique challenges and objectives of each study type.

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#12 Practical RWE – Training: Study Team Training2024-02-01T15:50:04+00:00

#11 Practical RWE – Documentation: Non-Interventional Study Protocols

#11 Practical RWE – Documentation: Non-Interventional Study Protocols

 

Having dedicated protocol templates for non-interventional studies (RWE studies) and clinical trials is a must rather than a ‘nice to have’ for several reasons:

  1. Different Objectives and Designs: Clinical trials and non-interventional studies have distinct objectives and designs. Clinical trials are designed to test the efficacy and safety of a new treatment under controlled conditions. In contrast, non-interventional RWE studies observe and analyse the outcomes of treatments in real-world settings without the researcher influencing or altering standard care practices.
  2. Regulatory Compliance: Clinical trials are subject to stringent regulatory requirements, including those set by the FDA, EMA, and other health authorities. These regulations ensure patient safety and data integrity and require specific protocol elements, such as detailed inclusion and exclusion criteria, randomization procedures, and stringent data collection methods. RWE studies, while also regulated, have different compliance requirements.
  3. Data Collection and Analysis: Clinical trials often involve rigorous data collection and analysis methods, including controlled environments, placebo controls, and double-blinding. RWE studies, on the other hand, typically rely on data from healthcare databases, patient registries, or routine clinical practice. Dedicated templates ensure that the protocols for each study type include appropriate guidelines for data collection, handling, and analysis.
  4. Risk Management: Different study types have different risk profiles. Clinical trials often involve unapproved treatments, requiring detailed risk management plans. RWE studies might involve fewer direct risks to participants but require careful consideration of data privacy and ethical concerns in observational settings. Separate templates can ensure that risk management is appropriately addressed in each type of study.
  5. Stakeholder Expectations: Clinical trials are often viewed as the gold standard for evidence generation, whereas RWE studies provide complementary insights into how treatments work in everyday clinical practice. Having distinct templates helps in clearly communicating the purpose, scope, and limitations of each study type to stakeholders.
  6. Efficiency and Clarity: Dedicated templates streamline the protocol development process for each study type. They ensure that researchers consider all relevant aspects and adhere to best practices specific to the study design. This clarity and efficiency can expedite the study approval process, reduce administrative burdens, and enhance the quality of the research.

In summary, having separate protocol templates for non-interventional studies and clinical trials is essential for aligning with specific study objectives, meeting regulatory requirements, ensuring appropriate data collection and analysis methods, managing risks effectively, meeting stakeholder expectations, and enhancing overall research efficiency and clarity.

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#11 Practical RWE – Documentation: Non-Interventional Study Protocols2024-02-01T15:40:30+00:00

#10 Practical RWE – Connecting the Dots: Regulatory Assumptions

#10 Practical RWE – Connecting the Dots: Regulatory Assumptions

 

Let’s start by assuming that you have done your homework, which means:

 

  1. You’ve classified your study in each region e.g., non-interventional study
  2. You’ve identified the relevant national regulations and guidelines

 

Now what? 

 

Now you need to consider whether there are any other conditions that are applicable to your study.  For example:

[1] Has the study been imposed by a regulatory authority as a condition of the marketing authorisation? Is it a  postmarket requirement (PMR = USA) or a post-authorisation safety study (PASS = EU)?

[2] Are there any study-specific research procedures? If so, will this impact the study classification and/or the ability conduct the study in the country of interest? Examples include the inability to take study-specific biosamples in Germany in the context of a (drug) non-interventional study.

[3] Are there any considerations specific to the patient population e.g., minors, minors who may progress to adulthood during the study term, legally incapacitated adults?

The answers to these questions allow you to start building the regulatory assumptions that form the basis of the regulatory roadmap for your study. In this instance, our study is a prospective post-authorisation safety study of a new treatment (Drug X) for prostate cancer in adults that has been imposed as a condition of the marketing authorisation by the EMA.  Based on this information we would build our regulatory assumptions like this…

Regulatory Assumptions

– Non-interventional post-authorisation safety study (PASS)

– Imposed PASS (Category 1)

– PRAC endorsement of protocol required

– EMA PASS protocol and report templates must be used

– Registration on the EU PAS register is mandatory

– Prospective data collection

– Retrospective data collection = Medical history

– Expedited safety reporting (as per GVP Module VI)

– Study conduct and scientific considerations (as per GVP Module VIII)

– Compliance with national regulatory requirements for non-interventional studies required

– Drug X is approved and prescribed in the study country

– Patients are adults (18 years and over)

– Study-specific biosamples required for genetic screening via a central lab (excludes Germany unless the study is conducted as a low-intervention clinical trial there)

These regulatory assumptions provide the foundation for creating a study-specific regulatory playbook and roadmap covering the national approvals, notifications, and study conduct considerations. 

Regulatory assumptions are important.  They detail, in simple language, the key elements of the study that drive the regulatory requirements and operational considerations.  Small changes to these regulatory assumptions can have a big impact on the study in terms of time, cost and feasibility.

Remember…small changes can have a big impact!

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#10 Practical RWE – Connecting the Dots: Regulatory Assumptions2024-02-01T15:26:16+00:00

#9 Practical RWE – Connecting the Dots: How to Identify Country-Specific Requirements for Non-Interventional Studies (NIS)

#9 Practical RWE – Connecting the Dots: How to Identify Country-Specific Requirements for Non-Interventional Studies (NIS)

 

Psstt…this is a secret…so please don’t tell anybody! 😳 🤔 😂

How do we identify the country-specific requirements for non-interventional studies? Much of our work with non-interventional studies involves determining what is NOT applicable.

We start with clinical trials…and run through this series of questions:

  1. What are the Requirements for Clinical Trials?
  2. Are NIS Covered in the Clinical Trial Regulations?
  3. Are There Specific Regulations for NIS?
  4. Are There Specific Regulations for Biomedical Research?
  5. Is There Local Guidance for Biomedical Research?

The answers to these questions help us to build our country-specific regulatory compliance roadmaps. Part of the process includes contacting competent supervisory authorities (e.g., IEC/IRB) to confirm (verify) NIS requirements.

Simple!

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#9 Practical RWE – Connecting the Dots: How to Identify Country-Specific Requirements for Non-Interventional Studies (NIS)2024-02-01T15:14:59+00:00

#8 Practical RWE – Connecting the Dots: The Declaration of Helsinki

#8 Practical RWE – Connecting the Dots: The Declaration of Helsinki

 

How often have you wondered “what do I need to do” when you’ve been faced with the prospect of running a non-interventional study?  Especially, if you are more familiar and comfortable with running clinical trials.

This is where I think we are missing a trick when we train team members in the requirements of ICH GCP.  Most GCP training skims over the foundational aspects…the ‘why’ we need to do the training (= prevent a reoccurrence of the Nazi doctor experiments)….why the Nuremberg Code and the Declaration of Helsinki were needed (= before they were created no international law or informal statement existed that differentiated between legal and illegal human experimentation).

The Declaration of Helsinki [ref 1] defines the “ethical principles for medical research involving human subjects”. This Declaration is the ethical foundation for:

  1. Clinical trials of drugs
  2. Non-interventional studies of drugs
  3. Observational studies (no drugs)
  4. Clinical trials and observational studies of medical devices

The Declaration of Helsinki forms the basis for ICH GCP (drugs) and ISO 14155 (GCP for medical devices)…and is the framework for non-interventional study regulations…globally.

Once you understand this, you will see the global similarities in the requirements for running non-interventional studies, which include:

  1. Study participation must be voluntary
  2. Voluntary informed consent is essential
  3. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.
  4. Researchers must have appropriate education, training, and qualifications
  5. Design and performance must be clearly described and justified in a protocol
  6. Protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed
  7. Protocol must be submitted for approval to a research ethics committee before the study begins
  8. The research study must be registered in a publicly accessible database before recruitment of the first subject.
  9. No amendment to the protocol may be made without approval by the research ethics committee.
  10. At the end of the study, researchers must submit a final report to the research ethics committee containing a summary of the study’s findings and conclusions.
  11. Researchers have a duty to make publicly available the results of their research are accountable for the completeness and accuracy of their reports.

 

References:

  1. World Medical Association (WMA) – Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (October 2013): https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
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#8 Practical RWE – Connecting the Dots: The Declaration of Helsinki2024-02-01T15:02:45+00:00

#7 Practical RWE – Clinical Study Classification: Interventional or Non-Interventional?

#7 Practical RWE – Clinical Study Classification: Interventional or Non-Interventional?

 

And so…we come to the most painful, controversial, and confusing of the definitions… ”intervention” and “interventional”.

Ideally, we would classify studies according to the level of intervention i.e., interventional, low intervention, and non-interventional. However, most regulators have been hesitant to define ‘intervention’ in their regulations. Only a few countries (e.g., USA, France, and South Africa) [refs 1 to 3] have defined “intervention” in the context of clinical trials.

If ‘intervention’ isn’t defined in the regulations of the region of interest it becomes difficult (impossible) to define what is, and is not, an intervention, and therefore what is, and is not, a clinical trial.

There is a simple solution.  Most countries define a ‘clinical trial’.

For example, in Europe:  ‘Clinical trial’ means a clinical study which fulfils any of the following conditions [ref 4]:

(a)  the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned;

(b)  the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or

(c)  diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects

So…when classifying a clinical study, the recommendation is to determine whether the proposed study is a clinical trial.

If the study isn’t a clinical trial, then what is it?

In Europe, a ‘non-interventional study’ is a clinical study other than a clinical trial [ref 4].

Therefore, in Europe both clinical trials and non-interventional studies (NIS) are investigations in humans that involves a medicinal product.  Whereas, clinical trials involve protocol-defined healthcare interventions, and NIS do not.

 

References:

[1] Section III.A of the FDA Guidance – Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (August 2023): https://www.fda.gov/media/171667/download

[2] Article L1121-1 of the Public Health Code (CSP): https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000032722870/

[3] Glossary of the Department of Health – Ethics in Health Research Guidelines: Principles, Processes and Structures (2015): https://www.health.gov.za/wp-content/uploads/2022/05/NHREC-DoH-2015-Ethics-in-Health-Research-Guidelines-1.pdf

[4] Article 2 of the EU Clinical Trials Regulation (Regulation EU/536/2014): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R0536-20221205

In essence, definitions lay the groundwork for accurate, consistent, and meaningful research, especially in areas where the data and its sources are as diverse and complex as in RWD and RWE.

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#7 Practical RWE – Clinical Study Classification: Interventional or Non-Interventional?2024-02-01T14:57:36+00:00

#6 Practical RWE – Clinical Study Classification: Non-Interventional Study or Low Intervention Clinical Trial?

#6 Practical RWE – Clinical Study Classification: Non-Interventional Study or Low Intervention Clinical Trial?

 

Ideally, we would classify studies according to the level of intervention i.e., interventional, low intervention, and non-interventional.

However, although we assume clinical trials are the opposite of non-interventional studies and are therefore ‘interventional’, most regulators have been hesitant to define ‘intervention’ in their regulations.

In Europe, the EU Clinical Trials Regulation [ref 1], defines ‘clinical trials’, ‘low interventional clinical trials’, and ‘non-interventional studies’.

By definition [ref 1], a clinical trial is an investigation in humans that involves a medicinal product and the assignment of the patient to a therapeutic strategy is decided in advance  by the trial protocol i.e., protocol-defined healthcare intervention.

In a low intervention clinical trial (LICT), the assignment of the patient to a therapeutic strategy is still decided in advance  by the trial protocol, but the medicinal product is approved and used as per marketing authorisation.  So once again there is a protocol-defined healthcare intervention. In the case of a LICT, there are additional patient safety considerations i.e., any additional diagnostic or monitoring procedures that are implemented as part of the LICT must pose no more than minimal additional risk or burden to the safety of the trial participants compared to normal clinical practice.  Why?  If you increase the degree of risk to the patient above normal clinical practice…you have exceeded the ‘low risk’ threshold and the trial reverts to a ‘normal’ clinical trial.

Another consideration for LICT is that there is allowance for using medicinal products off-label (e.g., paediatric or oncology drugs), but their use in this context must be supported by “published scientific evidence on the safety and efficacy of those investigational medicinal products”…and again…the trial must meet the ‘low risk’ requirements such that any additional diagnostic or monitoring procedures applied to the patient poses no more than minimal additional risk or burden to the safety of the trial participants compared to normal clinical practice. 

Put simply, clinical trials and low intervention clinical trials involve protocol-defined healthcare interventions.

What about non-interventional studies?

By definition [ref 1], a non-interventional study is an investigation in humans that involves a medicinal product and the assignment of the patient to a therapeutic strategy is NOT decided in advance  by the trial protocol i.e., there is NO protocol-defined healthcare intervention. This means there are NO protocol-specified activities or procedures that alter the patients’ treatment regimens or plans i.e., there are no additional diagnostic or monitoring procedures applied to the patient that impact the patients’ treatment.

In summary, in Europe both low intervention clinical trials (LICT) and non-interventional studies (NIS) are investigations in humans that involves a medicinal product.  LICT involve protocol-defined healthcare interventions, whereas NIS do not.

 

References:

[1] EU Clinical Trials Regulation (Regulation EU/536/2014): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R0536-20221205

In essence, definitions lay the groundwork for accurate, consistent, and meaningful research, especially in areas where the data and its sources are as diverse and complex as in RWD and RWE.

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#6 Practical RWE – Clinical Study Classification: Non-Interventional Study or Low Intervention Clinical Trial?2024-02-01T14:52:04+00:00

#5 Practical RWE – Clinical Study Classification: Retrospective or Prospective?

#5 Practical RWE – Clinical Study Classification: Retrospective or Prospective?

 

We often get confused when we use the terms ‘retrospective’ or ‘prospective’ in the context of a non-interventional study.

By definition [ref 1], a retrospective study collects data that was generated before the study was approved and a prospective study collects data that was generated after the study was approved.  Seems simple enough! 

In Europe, countries such as Germany [ref 2], Italy [ref 3], and Spain [ref 1] use the terms ‘retrospective’ and/or ‘prospective’.  Whereas, Austria has revised their non-interventional study guidance [ref 4] to state that:

“Retrospective data evaluations are studies that are carried out exclusively on data already collected for other reasons (in particular on the occasion of a curative treatment). Since retrospective data collection does not  involve a human study – which is required for the ‘clinical study’ under Article 2(2)(1) of the EU CTR – the  term  ‘clinical study’ (and thus also the legal definition of ‘non-interventional study’) is not fulfilled.”

Similarly, the research system in France focuses on research directly involving humans (RIPH e.g., clinical trials and non-interventional studies) [ref 5] and research which doesn’t (Non-RIPH e.g., secondary use of existing data).

Meaning?  In Austria and France, retrospective non-interventional studies aren’t actually…non-interventional studies. No wonder we get confused!

It could be argued that France is a leader in terms of the pivot from ‘retrospective and prospective’ to more contextual descriptors of ‘primary data and secondary data’.

This is very topical in the context of the European Health Data Space (EHDS) [ref 6], where ‘primary use of electronic health data’ means the processing of personal electronic health data for the provision of health services etc, and ‘secondary use of electronic health data’ means the processing of electronic health data for purposes such as scientific research.

Clearly, there is much work to do at the local level before we see the terms ‘retrospective’ and ‘prospective’ phased out and replaced with unified (and less confusing?) data descriptors, such as  ‘primary data’ and ‘secondary data’.  Until then…let the confusion abound!

 

References:

[1] Article 2(1)(b) of Royal Decree 957/2020 of November 3: https://www.boe.es/eli/es/rd/2020/11/03/957/con

[2] BfArM and PEI Joint Recommendations (Dec 2022): https://www.pei.de/SharedDocs/Downloads/DE/regulation/klinische-pruefung/awb-nis-pass-empfehlungen.pdf?__blob=publicationFile&v=4

[3] AIFA Determination March 20, 2008 – Guidelines for the classification and conduct of observational drug studies: https://www.medicoeleggi.com/argomenti000/italia2008/400078-a1.htm

[4] Federal Office for Safety in Health Care (BASG) – Guideline for the Differentiation of Clinical Studies: https://www.basg.gv.at/fileadmin/redakteure/06_Gesundheitsberufe/Klinische_Studien/NIS/Leitfaden_NIS_BMSGPK_BASG_2022-10-11_v01.pdf

[5] Article L1121-1 of the Public Health Code (CSP): https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000032722870/

[6] European Commission – European Health Data Space: https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en

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#5 Practical RWE – Clinical Study Classification: Retrospective or Prospective?2024-02-01T14:44:05+00:00
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