Erandio 





ERANDIO ERAIKITZEN 

abu 29 2010

San Agustín y el final del verano

Honek argitaratua: endi ordu honetan: 00:32:34 hemen: Erandio

Empieza el puerto de primera del mes de septiembre con los gastos de libros, cuadernos, material para el curso, uniformes, matrículas en natación, yudo, inglés… Después del verano los dolores de cabeza por los gastos extras. El Ayuntamiento iniciará el nuevo curso no sabemos si con ganas de hacer cosas o con el espíritu de ahorrar, pero seguimos con grandes obras, tanto en Astrabudua, como en Altzaga, como en los accesos a Arriagas y Kukularra.

¿Qué va a pasar cuando vuelva el tráfico al ritmo normal y con la carretera de la ría regulada por semáforo con un único carril?, ¿qué va a pasar con los autobuses que suben y bajan por la carretera a Goikoa y los de Altzaga Ikastola? Por cierto con riesgo de desprendimiento desde hace varios años y sin hacerse un muro de contención.

Lamentablemente en diez días veremos el follón de las carreteras principales regulados por semáforo y con unas obras que en agosto han contado con una presencia simbólica de personas en el tajo y sin personal del municipio y con mínima presencia de mujeres y eso que hay 746 paradas en Erandio.

San Agustín a finales de agosto va marcando el fin de las vacaciones de verano, para quienes pueden tenerlas, porque recordamos a las 1.524 personas en el paro en Erandio según en Ministerio de Trabajo.

Septiembre empieza con futbol, con ciclismo estatal pasando por Euskal Herria (en otras ocasiones lo ha hecho por Iparralde y por Francia), pero ahora se hace por imposición. Empieza con reforma laboral apoyada por el PNV, que se afianza como partido de derechas y defensor del mundo empresarial, contra los trabajadores y trabajadoras. Con negociación de presupuestos estatales, donde volveremos a oir hablar de compra venta en Euskadi. ¿Esta vez por cuanto seremos vendidos?

Ahora el turismo ha mejorado porque la kale borroka ha desaparecido, ahora la gente viene mas segura a Euskadi porque “I need Spain”, perdón que la quema de contenedores ha sido mala leche después de haber erradicado “ese problema” que no resolvía el predecesor de Ares.

Por cierto las jaiak de Astrabu y las de San Agustín, han contado con un recorte por parte del Ayuntamiento, en temas de imagen que habría que pensar si ha servido de algo: ausencia de wateres públicos, falta de decoración del municipio, falta de indicación de ubicaciones de barracas, txosnak y lugares de conciertos. Saliendo del metro de Astrabudua, para quien no es del barrio, no había indicación en los San Lorenzos y en Altzaga, el nuevo paseo TOTALMENTE LIBRE (excepto la churrería), las barracas no se ven, las txonas y los lugares de concierto escondidos.

Pero algo ha mejorado en el municipio, la venta ambulante se ha institucionalizado, el Ayuntamiento cobra por los puestos de venta de CDs y DVDs piratas, copias de bolsos, de ropa y de cinturones… habrá que cambiar la fiesta y decir que es la fiesta de la venta libre.

Menos mal que la gente joven sigue siendo alternativa y organiza cosas aunque sea sin el apoyo del Ayuntamiento. Ayer tuvimos concurso de putxeras y de bacalao al mismo tiempo, hoy domingo fin de fiestas. Para ver fuegos artificiales ya tenemos los de Bilbo, porque en Erandio no hay.

Por cierto, el otro día me comentaban como había alguna cuadrilla en los San Roques de Portu que portaban en sus camisetas la frase: “Eres mas vago que el hijo de Lalo”. Para quien no sepa quien es el hijo de Lalo, es un tal Francisco que ha dejado de vivir en Portu para ir a vivir a Gasteiz,

Etiquetas blog: carretera ; Erandio ; Jaiak ; kale borroka ; obras ; paro ; PNV ; presupuestos ; reforma laboral ;
Etiquetas todos los blogs: carretera ; Erandio ; Jaiak ; kale borroka ; obras ; paro ; PNV ; presupuestos ; reforma laboral ;

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    Es mejor posar para la foto y coger el twiter para decir que está cerca del pueblo.

    Ojala que la juventud empiece a hacer cosas y nos pase por la izquierda.

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    Anavar Guide: Benefits, Dosage, & Bodybuilding Insights

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    Anavar Guide for Bodybuilding: Benefits, Side Effects,
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    Anavar Benefits for Bodybuilding
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    Anavar Benefits for Bodybuilding

    - Increases lean muscle mass
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    **A concise guide for research teams on how
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    and regulatory compliance**

    | **Step** | **What you need to do** | **Why it matters** |
    **Key resources / guidance** |
    |———-|————————|——————–|——————————|
    | 1. Define the *scientific question* & *hypothesis* | Write
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    gap in knowledge and is specific enough for the study design you plan to use.
    | A strong hypothesis drives every subsequent decision (sample size, variables,
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    - NIH Blueprint for Clinical Research |
    | 2. Choose an *appropriate study design* (RCT, cohort, case‑control, etc.) | Match the question to a design that can answer
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    | The design determines how you’ll collect data, control confounders, and analyze
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    - TREND for non‑randomized trials |
    | 3. Conduct *sample size calculation* (power analysis)
    using estimated effect size, alpha, power, attrition.
    | Ensure enough participants to detect a clinically meaningful difference with acceptable Type
    I/II error rates. | Under‑powered studies risk false negatives; over‑powered waste resources and may detect trivial
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    |
    | 4. Develop *randomization scheme* if applicable: block
    randomization, stratified blocks, permuted blocks.

    | Balance known prognostic factors across arms to reduce
    bias. | Improper randomization can introduce allocation imbalance and threaten internal validity.
    | Implement via computer-generated lists or central randomization services.

    |
    | 5. Define *allocation concealment* mechanism (sealed opaque envelopes, centralized web‑based system).
    | Prevent selection bias by ensuring investigators cannot
    predict upcoming assignment. | Without proper concealment,
    researchers may influence enrollment based on expected allocation. |
    | 6. Draft the *protocol* including inclusion/exclusion criteria, intervention details, schedule of visits, safety monitoring plan, data collection methods, statistical analysis plan, and governance structure.
    | Provides a detailed roadmap for investigators and regulators; ensures consistency across sites.
    | Protocol deviations can compromise data integrity and lead to
    regulatory scrutiny. |
    | 7. Obtain *ethical approval* from institutional review
    boards (IRBs)/ethics committees at all participating centers.
    | Protects participant rights and safety; mandatory for publication and funding.
    | Failure to secure IRB approval may result in trial suspension or
    retraction of results. |
    | 8. Register the study on a public registry (e.g., ClinicalTrials.gov, EU Clinical Trials Register).
    | Enhances transparency; required by many journals and
    funding agencies. | Unregistered trials face criticism
    for potential selective reporting. |

    ### 2. Regulatory Pathways

    | **Regulatory Body** | **Primary Focus** | **Key Requirements for Clinical Trial** |
    |———————|——————-|——————————————|
    | **FDA (USA)** | Ensures safety and efficacy of drugs, biologics, and
    devices. | IND submission: preclinical data,
    manufacturing details, investigator’s brochure; periodic reporting; adverse
    event monitoring; final NDA or BLA review.
    |
    | **EMA (EU)** | Harmonizes drug approval across member states;
    oversees clinical trial authorization. | Clinical Trial Application (CTA) to
    national competent authority; Data Protection Authority (DPA) notification; EMA scientific advice
    for protocol design. |
    | **Health Canada** | Safeguards public health through rigorous assessment
    of medical products. | Clinical Trial Application (CTA) and Clinical Study Report (CSR); ongoing reporting; submission of New Drug Submission (NDS).
    |
    | **FDA (US)** | Protects consumers by ensuring safety, efficacy, and quality of drugs, biologics, and devices.
    | Investigational New Drug (IND) application; Institutional Review Board (IRB) approval;
    Clinical Trial Authorization; Periodic Safety Update
    Reports (PSUR). |

    These agencies operate under a set of internationally recognized
    principles that ensure consistency, transparency, and ethical
    rigor across the globe.

    ## 2. Core Principles Guiding International Medical Research

    | Principle | Definition | Key Elements |
    |———–|————|————–|
    | **Scientific Validity** | Ensures that studies are
    designed to answer relevant questions reliably and meaningfully.

    | Adequate sample size, appropriate methodology,
    control of confounding variables. |
    | **Human Subject Protection** | Safeguards the
    rights, safety, dignity, and welfare of participants.
    | Informed consent, privacy/confidentiality, risk minimization. |
    | **Transparency & Accountability** | Open reporting and oversight to
    foster trust and reproducibility. | Public protocols, data sharing,
    conflict-of-interest disclosure. |

    These principles are interdependent: rigorous science cannot exist without
    ethical conduct; ethical research demands transparency.

    ## 2. The “Human Subject” Definition in the
    U.S. Context

    ### 2.1 Original Scope (1979)

    - **Regulation**: 45 CFR §46.102
    - **Definition**: Any individual from whom data are obtained through:
    - *Interviews, questionnaires, or observation*; **or**
    - *Biospecimen collection or tissue sampling*.
    - **Implication**: Covered most behavioral and biomedical research.

    ### 2.2 Current Scope (2020)

    | Category | Original Definition | Current Definition |
    |———-|———————|——————–|
    | **Human Subject** | Any individual who participates in a
    study via interview, questionnaire, observation, or biospecimen/tissue collection. | Same as original;
    no expansion. |

    #### Impact of the Change

    - **No Expansion**: The definition has remained unchanged.

    - **Resulting Scope**:
    - Studies involving only anonymous data, public
    datasets, or purely computational simulations without direct interaction with human subjects
    are *not* considered “human subject” research under this
    definition.
    - However, if such studies use personally identifiable information (PII) or data that could be linked back to individuals, they may still fall under
    other regulatory frameworks (e.g., GDPR, HIPAA),
    but not the specific “human subject” category.

    ### 4. Summary of Regulatory Scope

    | **Regulation** | **Triggering Condition** | **Typical Study
    Types Covered** |
    |—————-|————————–|———————————|
    | FDA – Investigational New Drug (IND) | Human clinical trial with investigational drug or biologic |
    Phase I–III trials, dose‑finding studies, safety evaluations |
    | FDA – Investigational Device Exemption (IDE)
    | Clinical study of a medical device not yet cleared | Early‑stage
    implant trials, diagnostic imaging studies |
    | FDA – IND/IDE Not Required | Use of an already approved drug/device in a
    new context | Retrospective chart reviews, observational cohort studies |

    **Key Takeaway:**
    - **IND/IDE mandatory** only when the study involves *investigational* products or *new indications* for approved items.

    - For *retrospective*, *observational*, or *standard‑of‑care*
    investigations using *approved* drugs/devices, no IND/IDE is required.

    ## 2. Regulatory Frameworks and How They Apply

    | **Regulation / Guidance** | **Scope** | **Relevance to Retrospective Study (Approved Drug)** |
    |—————————|———–|—————————————————–|
    | **21 CFR Part 312 – Investigational New Drug (IND) Application** | New drugs,
    biologics, or medical devices not yet approved by FDA. | Not applicable if drug is already FDA‑approved and used in standard care.

    |
    | **21 CFR Part 314 – Current Good Manufacturing Practice (CGMP)**
    | Ensures quality of drug manufacturing. | No effect on retrospective data analysis.
    |
    | **21 CFR Part 56 – Institutional Review Board (IRB) Requirements** | Human subjects research oversight.
    | Applies to any study involving patient data; IRB must approve
    or waive review. |
    | **45 CFR Part 46 – Common Rule (Protection of Human Subjects)** | Ethical standards for human subject research, including informed consent.
    | Applies if patient data is used without de‑identification; may require waiver of consent for retrospective chart reviews.
    |
    | **HIPAA Privacy Rule (45 CFR Part 164.530-540)** | Protects PHI and sets rules for its use in research.

    | Requires either de‑identified data or a HIPAA authorization/waiver.
    |
    | **Office for Civil Rights (OCR) Enforcement** | Enforces compliance with HIPAA and Common Rule.
    | Non‑compliance can lead to civil penalties. |

    ## 2. Regulatory Pathways for Using Patient Data

    ### A. De‑Identified Data (Safe Harbor Method)

    | Step | Action |
    |——|——–|
    | **1. Remove PHI** | Delete all 18 identifiers: names, geographic data below the state level,
    all dates (except year), and any other unique codes that could identify
    a patient. |
    | **2. Verify Safe Harbor Criteria** | Ensure no individual can be identified through these remaining data
    elements or by combining them with external information. |
    | **3. Document De‑identification** | Create an audit trail:
    date of de‑identification, list of removed fields,
    and the methodology used. |
    | **4. Use Data** | The dataset is fully compliant; no
    further approvals required for research involving this data.

    |

    ### 2b) Using HIPAA “Limited Data Set” (LDS)

    If you need to retain dates or other identifiers that are not
    allowed in a public release, the data must be treated
    as a Limited Data Set.

    | Step | Action |
    |——|——–|
    | **1. Define LDS** | Confirm that the dataset includes only those
    elements permitted:
    • Dates (but not year of death)
    • Geographic subdivisions > 3 digits
    • Names, phone numbers, email addresses excluded. |
    | **2. Sign a Data Use Agreement (DUA)** | The holder must sign a formal DUA that specifies:

    - Purpose and scope of use.
    - Restrictions on further disclosure.
    - Security measures.
    - Obligation to return or destroy data after project completion. |
    | **3. Ensure compliance with HIPAA** | Verify that
    the dataset is either:
    • De-identified under §164.514(b) (all identifiers
    removed), or
    • Covered by a Business Associate Agreement if it contains
    PHI. |
    | **4. Data storage and security** | Implement appropriate safeguards
    (encryption, access controls). |
    | **5. Reporting obligations** | If any data breach occurs, report per HIPAA Breach Notification Rule.
    |

    Thus, the correct answer is **B: B** – you must
    provide an explanation of each required compliance step.

    ### 4. Final Output

    “`
    A
    B
    “`

    These are the two letters that correctly respond guide to using dianabol cycle 20mg the
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