Tag Archives: Clinical trial

1000 Studies Published Peer-Reviewed

Health Freedom Defense Fund, [Jan 8, 2022]
https://stevekirsch.substack.com/p/over-1000-studies-published-in-peer

MASKS

Peer-reviewed science papers that prove that prolonged use of masks causes hypercapnia, hypoxia and hypoxemia and irreversible brain damage – and can exacerbate illness.

https://pubmed.ncbi.nlm.nih.gov/18500410/

https://pubmed.ncbi.nlm.nih.gov/15340662/

https://www.nature.com/articles/s41598-018-35797-3

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4420971/

https://principia-scientific.com/?s=mask

Probably the Best Article yet written on the entire mask psyop (psychological operation). Dr Kelly Brogan:
https://kellybroganmd.com/masks-have-you-been-captured

https://lbry.tv/@joe-plummer:b/masks:6

STOP THE MASK WEARING INSANITY!! FACE MASKS DO NOT PROTECT YOU! HOWEVER THEY ARE HARMFUL AND IN SOME CASES CAN BE LIFE THREATENING. SCIENTIFIC studies below and some videos regarding the effectiveness of masks and any potential side effects. These are the things you’re not seeing in the mainstream media. Turn your TV off and start using critical thinking!
This is a review of several scientific studies that show that masks do not work:
https://www.greenmedinfo.com/search/google-cse#gsc.q=masks%20dont%20work%20review

Dangers of wearing a mask:
https://www.bitchute.com/video/cBR0zTOh0bLV/

Canadian Workplace Test Confirms Dangerous Oxygen Deprivation
https://www.bitchute.com/video/LP3BgJ8UofvO/

Over 3 times the risk of contracting influenza like illness if cloth mask is used
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4420971/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4420971/

https://bmjopen.bmj.com/content/5/4/e006577.full

https://www.cidrap.umn.edu/news-perspective/2020/04/data-do-not-back-cloth-masks-limit-covid-19-experts-say

The Physiological Impact of Wearing an N95 Mask During Hemodialysis as Precaution against SARS in Patients With End-Stage Renal Disease:
https://pubmed.ncbi.nlm.nih.gov/15340662/

Preliminary Report on Surgical Mask Induced Deoxygenation During Major Surgery:
https://pubmed.ncbi.nlm.nih.gov/18500410/

Rational use of face masks in the COVID-19 pandemic
https://www.thelancet.com/article/S2213-2600(20)30134-X/fulltext

Cloth masks can increase infection:
https://www.who.int/publications/i/item/advice-on-the-use-of-masks-in-the-community-during-home-care-and-in-healthcare-settings-in-the-context-of-the-novel-coronavirus-(2019-ncov)-outbreak
**From the WHO: There is limited evidence that wearing a medical mask by healthy individuals in the households or among contacts of a sick patient, or among attendees of mass gatherings may be beneficial as a preventive measure.14-23 However, there is currently no evidence that wearing a mask (whether medical or other types) by healthy persons in the wider community setting, including universal community masking, can prevent them from infection with respiratory viruses, including COVID-19.**

Prolonged wearing of the surgical mask causes loss of intellect potential and cognitive performance due to a decrease in blood oxygen and subsequent brain hypoxia. Note – some changes may be irreversible.

“Report on surgical mask induced deoxygenation during major surgery”
https://www.ncbi.nlm.nih.gov/pubmed/18500410

Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.

The injections are still in Stage 3 Clinical Trials that do not finish until early 2023

World Doctors Alliance, [Nov 5, 2021]
For those who tell you that the Covid-19 injection is authorised, approved or licensed remind them of these facts, especially if they are considering that the C19 injection is a good idea for children:

The injections are still in Stage 3 Clinical Trials that do not finish until early 2023:

Currently given emergency approval (EUA), Conditional Marketing Authorisation (CMA) etc all these terms mean they are only being used because of an “emergency” situation. These injections have not been fully licensed anywhere in the world.

AstraZeneca Trials: AZ Trials
Pfizer Trials :Pfizer Trials
AZ example short term approval terms: AZ Approval Terms
Pfizer example short term approval terms : Pfizer Approval Terms

The public should only begin to use drugs or vaccines that are in Stage 4 clinical trials

Pfizer tells us this : Stage 3 not normal

The animals trials for coronavirus vaccines have always failed because the animals got sick and/or died :

Studies in Ferrets : https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0035421
Cats: https://www.jstage.jst.go.jp/article/jvms/60/1/60_1_49/_article
Mice : https://pubmed.ncbi.nlm.nih.gov/22536382/
Mice: https://pubmed.ncbi.nlm.nih.gov/17194199/
Mice: https://pubmed.ncbi.nlm.nih.gov/18941225/

Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.

30 studies showing lockdowns don’t work

30 studies showing lockdowns don’t work:

1. https://onlinelibrary.wiley.com/doi/abs/10.1111/eci.13484

2. https://www.medrxiv.org/content/10.1101/2020.07.22.20160341v3

3. https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(20)30208-X/fulltext

4. https://advance.sagepub.com/articles/preprint/Comment_on_Dehning_et_al_Science_15_May_2020_eabb9789_Inferring_change_points_in_the_spread_of_COVID-19_reveals_the_effectiveness_of_interventions_/12362645

5. https://arxiv.org/pdf/2005.02090.pdf

6. https://www.datascienceassn.org/sites/default/files/Illusory%20Effects%20of%20Non-pharmaceutical%20Interventions%20on%20COVID19%20in%20Europe.pdf

7. https://www.timesofisrael.com/the-end-of-exponential-growth-the-decline-in-the-spread-of-coronavirus/

8. https://www.medrxiv.org/content/10.1101/2020.05.01.20088260v2

9. https://www.medrxiv.org/content/10.1101/2020.04.24.20078717v1

10. https://www.medrxiv.org/content/10.1101/2020.09.26.20202267v1

11. https://www.nicholaslewis.org/did-lockdowns-really-save-3-million-covid-19-deaths-as-flaxman-et-al-claim/

12. https://www.bmj.com/content/371/bmj.m3588

13. https://www.medrxiv.org/content/10.1101/2020.03.30.20047860v3

14. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2652751/

15. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3607803

16. https://imgcdn.larepublica.co/cms/2020/05/21180548/JP-Morgan.pdf

17. https://jamanetwork.com/journals/jama/fullarticle/2768086

18. https://www.medrxiv.org/content/10.1101/2020.10.09.20210146v3

19. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3665588

20. https://www.nber.org/papers/w27719

21. https://www.bmj.com/content/370/bmj.m3543

22. https://www.medrxiv.org/content/10.1101/2020.11.01.20222315v1

23. https://pandata.org/wp-content/uploads/2020/07/Exploring-inter-country-variation.pdf

24. https://www.nejm.org/doi/full/10.1056/NEJMoa2029717

25. https://www.medrxiv.org/content/10.1101/2020.08.04.20168112v1#:~:text=The%20seroprevalence%20of%20COVID%2D19,care%20workers%20in%20Niger%20State

26. https://www.frontiersin.org/articles/10.3389/fpubh.2020.604339/full

27. https://www.tandfonline.com/doi/abs/10.1080/00779954.2020.1844786?journalCode=rnzp20

28. http://www.upmc-biosecurity.org/website/resources/publications/2006/2006-09-15-diseasemitigationcontrolpandemicflu.html

29. https://www.medrxiv.org/content/10.1101/2020.12.25.20248853v1

30. https://www.medrxiv.org/content/10.1101/2020.12.28.20248936v1

Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.

30 Studies Showing Lockdowns Don’t Work

30 studies showing lockdowns don’t work:

1. https://onlinelibrary.wiley.com/doi/abs/10.1111/eci.13484

2. https://www.medrxiv.org/content/10.1101/2020.07.22.20160341v3

3. https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(20)30208-X/fulltext

4. https://advance.sagepub.com/articles/preprint/Comment_on_Dehning_et_al_Science_15_May_2020_eabb9789_Inferring_change_points_in_the_spread_of_COVID-19_reveals_the_effectiveness_of_interventions_/12362645

5. https://arxiv.org/pdf/2005.02090.pdf

6. https://www.datascienceassn.org/sites/default/files/Illusory%20Effects%20of%20Non-pharmaceutical%20Interventions%20on%20COVID19%20in%20Europe.pdf

7. https://www.timesofisrael.com/the-end-of-exponential-growth-the-decline-in-the-spread-of-coronavirus/

8. https://www.medrxiv.org/content/10.1101/2020.05.01.20088260v2

9. https://www.medrxiv.org/content/10.1101/2020.04.24.20078717v1

10. https://www.medrxiv.org/content/10.1101/2020.09.26.20202267v1

11. https://www.nicholaslewis.org/did-lockdowns-really-save-3-million-covid-19-deaths-as-flaxman-et-al-claim/

12. https://www.bmj.com/content/371/bmj.m3588

13. https://www.medrxiv.org/content/10.1101/2020.03.30.20047860v3

14. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2652751/

15. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3607803

16. https://imgcdn.larepublica.co/cms/2020/05/21180548/JP-Morgan.pdf

17. https://jamanetwork.com/journals/jama/fullarticle/2768086

18. https://www.medrxiv.org/content/10.1101/2020.10.09.20210146v3

19. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3665588

20. https://www.nber.org/papers/w27719

21. https://www.bmj.com/content/370/bmj.m3543

22. https://www.medrxiv.org/content/10.1101/2020.11.01.20222315v1

23. https://pandata.org/wp-content/uploads/2020/07/Exploring-inter-country-variation.pdf

24. https://www.nejm.org/doi/full/10.1056/NEJMoa2029717

25. https://www.medrxiv.org/content/10.1101/2020.08.04.20168112v1#:~:text=The%20seroprevalence%20of%20COVID%2D19,care%20workers%20in%20Niger%20State

26. https://www.frontiersin.org/articles/10.3389/fpubh.2020.604339/full

27. https://www.tandfonline.com/doi/abs/10.1080/00779954.2020.1844786?journalCode=rnzp20

28. http://www.upmc-biosecurity.org/website/resources/publications/2006/2006-09-15-diseasemitigationcontrolpandemicflu.html

29. https://www.medrxiv.org/content/10.1101/2020.12.25.20248853v1

30. https://www.medrxiv.org/content/10.1101/2020.12.28.20248936v1

Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.

Clinical Programmer Available for Consultancy projects.

Clinical Programmer Available for consultancy projects – Medidata Rave Certified.

Rate: Negotiable

Hours: part time or full time

Contracts: 1099 or Corp-2-corps only.

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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The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary, If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision.

Disclaimer:De inhoud van deze columns weerspiegelen niet per definitie de mening van {EDC Developer}.

Before Your Trial Goes Live – InForm FastStart

When EDC is used in a clinical trial, electronic case report form (e-CRF) data are defined to be the data that are manually entered into a computer by the patient or by the investigator’s staff.

CDISC defines e-CRF as a CRF in which related data items and their associated comments, notes, and signatures are linked electronically.

e-CRFs may include special display elements, electronic edit checks and other special properties or functions used for both capture and display of the linked data.

Prior to submitting a request – FastStart, you should throughly test your trial.

Technically speaking, FastStart requests ensures base is cooked when sending all UAT versions of the trial, Training and Production versions of the trial to Oracle implementation team. This will vary on the type of contract your company / sponsor has with them.

Your company or sponsor may have a setup of ‘Implementation’ instructions that will be provided to Oracle HSG (formerly PhaseForward) that includes all files, summary and instructions for each implementation. Some of these required files or special files are listed below.

Special Files:

Filename Contents
Customresources.XML Collects references to any html files that will be use to override standard InForm functionality within the trial. Includes the visit calculator (VISITCALCULATOR.HTML) and confirmation of enrollment message (ENROLLMENTCONFIRM.HTML).
InsertUsers.XML User details
InsertSites.XML Site details
InsertSiteGroups.XML Links users with specific sites
InsertGroups.XML Defines the properties and contents of groups e.g. queries, items
InsertRightsGroups.XML Groups multiple access rights, with details of specific users that are assigned those rights.Also contains details of any overrides to default levels of access at item level
InsertSignCRF.XML Defines form to be signed and group who have access to sign
Crbaffadavit.TXT Affadavit text which appears when signing the eCRF (used at eCRF level). The text is standard, but protocol number must be amended for each trial. NOTE: This file will be used for any trials using casebook level signatures.
logo.jpg Your company logo
EnrollmentOverride.htmlHomedefault.html Here you can modify your trial name

The eSignature is a replacement for the Investigator’s physical signature (paper form). This file captures confirmtion from the Investigator that he has reviewed and confirmed the information on each eCRF is accurate. This Affidavit text contains something like ‘I, Principal Investigator, for study 9999999, confirm I have reviewed this CRF form….’

Investigator– 21 CFR 50.3(d) defines the investigator as “The individual who actually conducts a clinical investigation – i.e., under whose immediate direction the test article is administered.”

Some recomendations about eSignature can be further research on Secure Access For Everyone (SAFE) standards. The goal is that once the investigator is credentialed by SAFE, his/her identity and electronic signature can be used by all SAFE compliant sponsors.

InsertUsers File

Training must be provided to sponsors users prior to granting access to an InForm trial. For example, CRAs will need to be well trained on all aspects of the EDC system in order to provide coaching for the investigator. This file documents all sponsors and site staff users within each clinical trial.

Easy, wasn’t it? Again, build your trial and test to make sure all files were cooked and working as expected. Log into your trial and ensure that the special files appear correctly. Enroll a subject to ensure the enrollment confirmation screen appears and, if used in the trial, the visit calculator appears.

Reference:

Electronic Clinical Data Capture, Position Paper Revision 1, May 1, 2005

How to manage Sites and Users in InForm Trial

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.

ClinCapture® Tutorial – How to enter a patient schedule a visit and start entering data

ClinCapture® Tutorial – How to enter a patient, schedule a visit and start entering data – YouTube.

ClinCapture® is the most advanced open-source electronic data capture (EDC) system designed to streamline your clinical trials. As an open-source solution, ClinCapture® is tailored to meet the needs of life science companies looking to run cost-effective clinical trials.

ClinCapture® can be rapidly deployed and easily adopted, customizable to specific study requirements. ClinCapture® is repeatedly chosen as a preferred EDC solution because it is intuitive, flexible, and proven.

Source: Clinovo

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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”.