Tag Archives: clinical research companies

CDC Quietly Changed Basis Of Essential Public Health Services From ‘Research’ To ‘Equity’

https://www.dailywire.com/news/cdc-quietly-changed-basis-of-essential-public-health-services-from-research-to-equity

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Video: “Crimes Against Humanity”: The German Corona Investigation. “The PCR Pandemic”

The German Corona Investigative Committee has taken testimony from a large number of international scientists and experts since July 10, 2020.

Scroll down for the Video and Full Transcript of Dr. Reiner Fuellmich‘s  presentation.

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Their conclusions are the following: 

  • The corona crisis must be renamed the “Corona Scandal”
  • It is:
    • The biggest tort case ever
    • The greatest crime against humanity ever committed
  • Those responsible must be:
    • Criminally prosecuted for crimes against humanity
    • Sued for civil damages
  • Deaths
    • There is no excess mortality in any country
    • Corona virus mortality equals seasonal flu
    • 94% of deaths in Bergamo were caused by transferring sick patients to nursing homes where they infected old people with weak immune systems
    • Doctors and hospitals worldwide were paid to declare deceased victims of Covid-19
    • Autopsies showed:
      • Fatalities almost all caused by serious pre-existing conditions
      • Almost all deaths were very old people
      • Sweden (no lockdown) and Britain (strict lockdown) have comparable disease and mortality statistics
    • US states with and without lockdowns have comparable disease and mortality statistics
  • Health
    • Hospitals remain empty and some face bankruptcy
    • Populations have T-cell immunity from previous influenza waves
    • Herd immunity needs only 15-25% population infection and is already achieved
    • Only when a person has symptoms can an infection be contagious
  • Tests:
    • Many scientists call this a PCR-test pandemic, not a corona pandemic
    • Very healthy and non-infectious people may test positive
    • Likelihood of false-positives is 89-94% or near certainty
    • Prof. Drosten developed his PCR test from an old SARS virus without ever having seen the real Wuhan virus from China
    • The PCR test is not based on scientific facts with respect to infections
    • PCR tests are useless for the detection of infections
    • A positive PCR test does not mean an infection is present or that an intact virus has been found
    • Amplification of samples over 35 cycles is unreliable but WHO recommended 45 cycles
  • Illegality:
    • The German government locked down, imposed social-distancing/ mask-wearing on the basis of a single opinion
    • The lockdown was imposed when the virus was already retreating
    • The lockdowns were based on non-existent infections
    • Former president of the German federal constitutional court doubted the constitutionality of the corona measures
    • Former UK supreme court judge Lord Sumption concluded there was no factual basis for panic and no legal basis for corona measures
    • German RKI (CDC equivalent) recommended no autopsies be performed
    • Corona measures have no sufficient factual or legal basis, are unconstitutional and must be repealed immediately
    • No serious scientist gives any validity to the infamous Neil Ferguson’s false computer models warning of millions of deaths
    • Mainstream media completely failed to report the true facts of the so-called pandemic
    • Democracy is in danger of being replaced by fascist totalitarian models
    • Drosten (of PCR test), Tedros of WHO, and others have committed crimes against humanity as defined in the International Criminal Code
    • Politicians can avoid going down with the charlatans and criminals by starting the long overdue public scientific discussion
  • Conspiracy:
    • Politicians and mainstream media deliberately drove populations to panic
    • Children were calculatedly made to feel responsible “for the painful tortured death of their parents and grandparents if they do not follow Corona rules”
    • The hopeless PCR test is used to create fear and not to diagnose
    • There can be no talk of a second wave
  • Injury and damage:
    • Evidence of gigantic health and economic damage to populations
    • Anti-corona measures have:
      • Killed innumerable people
      • Destroyed countless companies and individuals worldwide
    • Children are being taken away from their parents
    • Children are traumatized en masse
    • Bankruptcies are expected in small- and medium-sized businesses
  • Redress:
    • A class action lawsuit must be filed in the USA or Canada, with all affected parties worldwide having the opportunity to join
    • Companies and self-employed people must be compensated for damages

To read the entire article go here…https://www.globalresearch.ca/video-crimes-against-humanity-the-german-corona-investigation/5725795

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Featured image is from PixabayThe original source of this article is Dr. Reiner FuellmichCopyright © Reiner FuellmichDr. Reiner Fuellmich, 2020

https://www.zerohedge.com/geopolitical/european-leader-predicts-covid-hell-will-trigger-monumental-populist-backlash

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OpenClinica: Printing subject casebooks, blank casebooks and blank CRFs

Wanna print subject casebooks using OpenClinica? This article is an extract from a video demo from the OpenClinica blog website. Click the link below now.

Source: http://blog.openclinica.com/2014/10/06/video-demos-printing-subject-casebooks-blank-casebooks-and-blank-crfs/

Happy Printing!!!

 

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Clinical Trials 101

Clinical trials are research studies that involve people and test new ways to prevent, detect, diagnose, or treat cancer and other diseases. At the conclusion of this webinar, you will be able to demonstrate a basic understanding of the basics of clinical trials, including how they work, protections for participants and factors related to participation.

Source: NCI Events

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anayansi gamboa

How to Manage Sites and Users in InForm Trial?

So you created your first InForm Trial and now what? Before you can actually enter data into your trial, you need to set up a user management system which assigns permissions to different users in your system depending on their job “role”.

In InForm, this is accomplished by using a tool called ‘User Management Tool’ or simple UMT. This tool allows sponsor to manage sites and users once the trial have gone live. There may be many different user groups with different levels and ranges of permissions.

Creating an InForm Trial – UMT:

  1. Create your InForm trial in the UMT. I won’t go into details on how to actually do this and depend upon the contract agreement with the vendor (i.e. Oracle/PhaseForward); they will perform this task for you.
  2. Select Trial Version = latest InForm version (i.e. 5.0)
  3. Select Countries where this trial will take place
  4. Select Status. Each InForm trial has 4 main statuses.
    1. Fast Start = Pre-Go Live
    2. Fast Forward = Trial is now live
    3. Fast Lock = Trial is lock
    4. Decommission = Trial is completed/archived

Managing users and groups can be a tedious task but tools such as UMT makes them easier to manage.

Roles: Roles (e.g. CRA, PI, System Administrator, etc) are used to assign specific permissions to individual users or groups, typically to perform specific functions in the InForm system.

The system allows you to either manually enter a role or import using a template called ‘MUL’ or Masters Users List. If you decided to upload your rights and roles via MUL, the system will generate a log file. It is imperative that you check this file and check any errors before proceeding.

Once the roles have been added to the UMT, you need to approved them before you build your clinical trial. The system also comes with defaulted and approved rights and roles.

Another option available is to create what is called as ‘signature groups’. If you are familiar with Medidata Rave system, this is equivalent to checking the ‘Signature required’ box and setting the investigator signature in Architect project main page.

Common use of Signatures in clinical trials are at the form level (i.e. 1 signature per form or at the subject level or studybook = 1 signature per subject).

Item Groups: Items groups is used to overrides or restrict a particular user access to a form or field. This is equivalent to ‘Restrictions – View/Entry’ in Medidata Rave.

One good example of display override usage is the coding fields restrictions. If only Clinical Coders are allowed to view / entry data on those items, you will limit access to all roles but the coders role.

Here’s a snippet of the code in .XML:

<!–?xml version=”1.0″?>–>
<MEDMLDATA xmlns=”PhaseForward-MedML-Inform4″>
/*some other code goes here*/
<ITEMGROUP
GROUPNAME=”Hidden Coding Items”
GROUPDESCRIPTION=”Hidden Coding Items”>
<!– Insert ItemRef Names –>
<ITEMREF REFNAME=”PT_NAME”/>
<ITEMREF REFNAME=”HLGT_NAME”/>
<ITEMREF REFNAME=”HLT_NAME”/>
<ITEMREF REFNAME=”LLT_NAME”/>
<ITEMREF REFNAME=”SOC_NAME”/>
</ITEMGROUP>
</MEDMLDATA>

Two other important groups that you need to be aware of is the Query and the Report Groups. The former, as the name entails, allows a user to open, answer, reissue and close queries during the course of a clinical trial. The latter, allows a particular user to run reports.

For example, an Ad Hoc User can access Ad Hoc reports via Cognos. The roles associated to this group could be your project manager, Clinical Research Associate (CRA) or your Lead Data Manager (LDM/CDM).

Once you have completed your basic setup, you will need to prepare or cook those xmls files onto your clinical trial. The rights/roles we discussed needs to be in an approved status. You also want to make sure you ‘lock for QC’ or lock the trial to prevent anyone from making changes to already added sites/users.

Sites and Users marked for upload to InForm will automatically be cooked into your trial.

Last step we need to take is to generate the XML files by selecting the link ‘Generate InFormXML.’ Now, your UAT trial is created, your URL is set up and you are ready to perform User Acceptance Testing.

Remember to validate your XML files, especially if your clinical trial is running across several countries. I have found issues with foreign languages symbols or special characters entered in the UMT system. Avoid at all cost any special characters.

Source: User Management Tool Reference Guide from PhaseFoward

Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.

Data Management Plan in Clinical Trials

 

The preparation of the data management plan (DMP) is a simple, straightforward approach designed to promote and ensure comprehensive project planning.

The data management plan typically contains the following items. They are:

  1. Introduction/Purpose of the document
  2. Scope of application/Definitions
  3. Abbreviations
  4. Who/what/where/when
  5. Project Schedule/Major Project Milestones
  6. Updates of the DMP
  7. Appendix

The objective of this guidelines is to define the general content of the Data Management Plan (DMP) and the procedures for developing and maintaining this document.

The abbreviation section could include all acronyms used within a particular study for further clarification.

e.g. CRF = Case Report Form
TA = Therapeutic Area

The Who/What/Where/When section should describe the objective of the study specific data management plans for ABC study. This section provides detail information about the indications, the number of subjects planned for the study, countries participating in the clinical trial, monitoring guidelines (SDV) or partial SDV, if any CROs or 3rd party are involved in the study (e.g. IVRS, central labs), which database will be used to collect study information (e.g. Clintrial, Oracle Clinical, Medidata Rave or Inform EDC).

The Appendix provides a place to put supporting information, allowing the body of the DMP to be kept concise and at more summary levels. For example, you could document Database Access of team members, Self-evident correction plan, Data Entry plan if using Double-data entry systems or Paper-Based clinical trials systems.

Remember, this is a living document and must be updated throughout the course of the clinical trial.

If problems arise during the life of a project, our first hunch would be that the project was not properly planned.

Reference: Role of Project Management in Clinical Trials
Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.

To hire me for services, you may contact me via Contact Me OR Join me on LinkedIn

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.

Adverse Event Monitoring for CRAs

During monitoring visits one of the most important and impacting activities that a CRA performs is the source document verification of Adverse Events. The CRA is the eyes for the research sponsor when it comes to proper collection and documentation of subject safety information. Incorrect and inadequate monitoring of adverse events can lead to inaccurate labeling for clinical trials and impact market application inspectional reviews, as well as post marketing labeling. The safety regulatory and ICH definitions will be reviewed and applied to the monitoring process. This includes Causality, Expectedness/Unanticipated, and other important concepts. Case scenarios will be used to apply the information for better learning.

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I Need a Relational Database

What is a Relational Database?
A relational database is a collection of database objects: tables maintaining relationships based on the primary/foreign key principle, various means of manipulating these tables, and the rules that enforce the relationships and their integrity. Unlike spreadsheet tables or flat files, RDBMS tables are related in a parent/child-like relationship.

This video was made and uploaded with Xtranormal’s State

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Build me a Database

A business leader wants a database

What is a Database?
A database is a collection of data. That may sound overly simplistic but it pretty much sums up what any database is.

Different type of databases: Oracle, SQL Server, MS Access, MySQL, Postgresql etc.

Oracle databases are the de facto standard for large Internet sites, and Oracle advertisers are boastful but honest when they proclaim,

The Internet Runs on Oracle.”

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Introduction to Clinical Trials

Video introducing cancer clinical trials and their use in clinical practice guidelines

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Source: Cancer Guidelines – Canada