Donations are tax deductible to the full extent of the law. pic.twitter.com/KmSpn2W5ui. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for the. Ventavia employed Relator Jackson as a Regional Director. Enough is enough! Signed by District Judge Michael J. Truncale on 6/9/22. She said she holds a certificate in clinical trial auditing from Barnett International, which offers a 30-hour course. Brook Jackson. The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November. (kcv, ) (Entered: 06/09/2022), PROTECTIVE ORDER. Filing fee $ 100, receipt number 0540-8872762. According to a police officer who spoke to the media, the attack was Snyder, who was remembered in his obituary as a "well-rounded student Ending booster shot dilemma: Lancet study says third Covid jab not needed, International Business Times, Singapore Edition, SHOCKING: Man Rapes Dog Inside Park in India as Delhi Police Refuse to Arrest Suspect [GRAPHIC], Dilbert Comic Strip Gets Canceled by Hundreds of Newspapers Over Creator Scott Adams' 'Racist Rant', East Meets West: Two Spirits Industry Visionaries Join Forces to Bring Portfolio of Unique, Super-Premium, Hand-Crafted Japanese Spirits to the US Market, 'Never-Ending War of Attrition': Thousands Rally in Germany Calling for End to Weapons Supply to Ukraine, Camilla Will Officially Be Called 'Queen' and Not 'Queen Consort' after King Charles' Coronation, 'Confused' Joe Biden Says 'Who is Zooming Who' When Asked About East Palestine Visit? brook jackson, plaintiff, v. ventavia research group, llc; pfizer Feb. 28, 2023, 10:25 a.m. CST, Assigned To: The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to Signed by District Judge Michael J. Truncale on 5/4/2022. Were going to get some kind of letter of information at least, when the FDA gets here . (Entered: 05/17/2022), NOTICE by Ventavia Research Group, LLC re 41 MOTION to Stay re 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support and Notice of Joinder in Pfizers Motion to Stay Discovery, 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support - Notice of Joinder in Pfizer and Icon's Motions to Stay Discovery (Brainin, Stacy) (Entered: 05/17/2022), STATUS REPORT Joint Report of Attorney Conference by Pfizer, Inc.. (Attachments: # 1 Exhibit A - Proposed Scheduling Order, # 2 Exhibit B, # 3 Exhibit C)(Wessel, Carlton) Modified Exhibit description on 5/18/2022 (kcv, ). As Ive said before, we are operating at the speed of science, Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1. Her job was to oversee its clinical trial of Pfizers not People working in clinical research are terrified of FDA audits, Jill Fisher told The BMJ, but added that the agency rarely does anything other than inspect paperwork, usually months after a trial has ended. After the explosive whistleblower report came out, shares of BioNTech, the German company that co-developed the vaccine with Pfizer, took a drastic 20% plunge on Friday, November 5. Signed by District Judge Michael J. Truncale on 10/19/22. Lead Stories is a U.S. based fact checking website that is always looking for the latest false, misleading, deceptive or Under the False Claims Act, whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. Jury Selection and Trial reset for 7/8/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. 13. Professor Douglas Drevets, M.D., of the University of Oklahoma College of Medicine, wrote in a November 10, 2021, email to Lead Stories that even if the claims are true, there is abundant proof the Pfizer vaccine works and is safe. *** MOTION to Stay re 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support and Notice of Joinder in Pfizers Motion to Stay Discovery by Icon, PLC. However, a 2016 U.S. Supreme Court decision that expanded the scope of a legal principle known as materiality resulted in a series of federal court decisions in which fraud cases brought under the False Claims Act were dismissed. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson (video 1), emailed a complaint to the US Food and Drug Administration (FDA). Our response is here, we stand by our reporting. Relator shall have until October 27, 2022 to respond. p. 1. technical support for your product directly (links go to external sites): Thank you for your interest in spreading the word about The BMJ. (Anderson, Lexis) (Entered: 03/02/2022), ***FILED IN ERROR. She said she is fully vaccinated and is not an anti-vaccine activist. EPA Green Lights Climate-Friendly Fuel From Discarded Plastics Despite High Cancer Risk, Fake Meat: Another Attempt for Global Control of the Food Supply, Mainstream Media Exposes The Real Anthony Fauci, Selfie Campaign I Know the Real Anthony Fauci. Its a crazy mess.. (kcv, ) (Entered: 10/14/2022), Unopposed MOTION to Withdraw Peter Linken as Counsel by Icon, PLC. 7. (Mendenhall, Warner) (Entered: 08/22/2022), ***FILED IN ERROR. Signed by District Judge Michael J. Truncale on 6/9/22. However, most have not run corrections, despite overwhelming evidence contradicting their statements. An open letter from Pfizer chairman and CEO Albert Bourla. In an article in MedPage, vaccine experts said the claims are not serious enough to jeopardize Pfizer's data. Want something more? Donations are tax deductible to the full extent of the law. Plaintiff, Jurisdiction Type: ***Defendant's Unopposed First Application for Extension of Time to Answer Complaint re Pfizer, Inc..( Yeates, Tommy) Modified on 3/18/2022 (kcv, ). Young Indian Cop Collapses, Dies Suddenly While Exercising at Gym; Heart Attack Caused by Covid-19 Vaccine? Please select all the ways you would like to hear from Lead Stories LLC: You can unsubscribe at any time by clicking the link in the footer of our emails. THANKS !!! (Entered: 10/11/2022), ORDER granting the 71 Motion for Leave to Respond to Statement of Interest. It just seemed like something a little different from normalthe things that were allowed and expected.. She then emailed a complaint to the US Food and Drug I dedicated my near two decade career to helping get safe and effective therapeutics, vaccines, and devices to consumers. Pfizer delegated management of the clinical trial to subcontractor Defendant Icon PLC (Icon), an Irish clinical research organization. (Entered: 01/18/2022), ORDER on the Government's 13 Notice of Election to Decline Intervention. The next day the FDA issued the authorisation of the vaccine.8, In August this year, after the full approval of Pfizers vaccine, the FDA published a summary of its inspections of the companys pivotal trial. Brook Jackson whistleblower lawsuit allegations against Ventavia Pfizer and Icon, Defendants admit fraud by filing that fraud is not material to the contract. Brook Jackson . Signed by District Judge Michael J. Truncale on 11/15/22. Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). (Entered: 03/18/2022), CORPORATE DISCLOSURE STATEMENT filed by Pfizer, Inc. (Yeates, Tommy) (Entered: 03/18/2022), Defendant's Unopposed First Application for Extension of Time to Answer Complaint is granted pursuant to Local Rule CV-12 for Pfizer, Inc. to 4/22/2022. We also published an article titled "Context Matters: Why Lead Stories Fact Checked The BMJ" to further clarify the reasons for the fact check after the BMJ published another article claiming this was an case where "fact checking goes wrong". The full trial (registered under NCT04368728) enrolled around 44000 participants across 153 sites that included numerous commercial companies and academic centres. What I documented and reported to my former employer and to Pfizer during an internal audit was dangerous and violated Federal law. Public Citizen. Pfizer is a federal contractor because it signed, with the U.S. government to provide COVID-19 vaccines and. Brook Jackson. Well done you ETHICAL LADY for hoping to protect general members of the public and VENTAVIA should be brought to book for lack of Duty of Care. BMJ relied on copies of reports filed by a two-week employee of Ventavia. CourtListener is sponsored by the non-profit Free Law Project. Part of my responsibility was to ensure the rights, safety, and welfare of the people volunteering to be in the study was protected, and that the information collected from each of them was supported by the highest data integrity standards. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. The regional director for Ventavia, Jackson was fired immediately after she Jackson has contacted media organizations that have published these false allegations, sharing documentation that shows her work on the trial, and asking for corrections.. (Katz, Elai) (Entered: 04/12/2022), Notice of Attorney Appearance - Pro Hac Vice, NOTICE of Attorney Appearance - Pro Hac Vice by Peter Linken on behalf of Icon, PLC. Document # 21, Defendant's Unopposed First Application for Extension of Time to Answer Complaint was filed incorrectly with an attachment. Elsewhere on Twitter, the Brook Jackson account wrote that vaccination makes sense if a person is in a high-risk category and called a 5th Circuit Court of Appeals ruling against the Biden Administration's vaccine mandates "HUGE!". In one example CIRCARE and the US consumer advocacy organisation Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants.4 Nine months later, in April 2019, an FDA investigator inspected the clinical site. To create additional alerts, please install the RECAP Extension or become a monthly donor. On September 7, 2020, Brook Jackson began her employment with Ventavia Research Group (Ventavia) as a Regional Director. Telephonic Status Conference set for 12/13/2022 at 05:00 PM before District Judge Michael J. Truncale. WebRetraction Letter - Brook Jackson Contributed by Paul Thacker . Lauren Foreman, director of business development & communications, wrote: The accuser was employed for approximately two weeks in September 2020, and no part of her job responsibilities concerned the clinical trials at issue. Competing interests: PDT has been doubly vaccinated with Pfizers vaccine. Our content exposes the corporations, elected officials, government agencies and individuals who put profits before people and planet. Drevets, who heads the infectious diseases department at University of Oklahoma Health Sciences Center, said the millions of doses administered more than prove this: there have been so many other studies of the Pfizer COVID-19 vaccine since the Phase III trial that people can be confident in its efficacy and safety profile. Brook Jackson. If you might need an exception, please let us know. ( kcv, ), SUMMONS Returned Executed by United States of America ex rel. She then reported her concerns in an email to the agency. Sign up to receive the Free Law Project newsletter with tips and announcements. If you are unable to import citations, please contact PLEASE IGNORE. Filing fee $ 100, receipt number 0540-8872723. PLEASE IGNORE. (jmv, ), AMENDED SCHEDULING ORDER granting 78 Defendants' Motion to Continue Discovery Deadlines. Pfizer and Icon turned a blind eye to Ventavias misconduct, despite numerous warning signs. According to Jackson, Ventavia "falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer's pivotal phase III trial. (Entered: 06/06/2022), MOTION to Dismiss 17 Relator's Amended Complaint by Icon, PLC. The article, which revealed Jacksons claims that Ventavia falsified data, unblinded patients, employed inadequately trained vaccinators and was slow to follow up on adverse events reported by trial participants, raised serious doubts about the data integrity and regulatory oversight of the critical Pfizer trials. (kcv, ) (Entered: 10/20/2022), RESPONSE to 70 Response in Support of Motion filed by United States of America ex rel. To receive new posts and support my work, consider becoming a free or paid subscriber. Ventavia executives later questioned Jackson for taking the photos. ICON reminded Ventavia in a September 2020 email: The expectation for this study is that all queries are addressed within 24hrs. ICON then highlighted over 100 outstanding queries older than three days in yellow. Dec 2020. For information about our privacy practices, please visit our website. It's free. WebI Am Brook Jackson | Whistleblower for Pfizer's Clinical Trials DONATE WHO I AM I dedicated my near two decade career to helping get safe and effective therapeutics, Its mission is to end childhood health epidemics by working aggressively to eliminate harmful exposures, hold those responsible accountable, and to establish safeguards to prevent future harm. Several documents show that Jackson worked on Pfizers clinical trial, Thacker wrote on Nov. 30. She was tasked with overseeing site management, patient enrollment, quality assurance completion, event reporting, corrective action plan creation, communication with management, and staff training completion at the Keller and Fort Worth sites. Update: In response to this fact check the BMJ published an open letter to Mark Zuckerberg. (kcv, ) (Entered: 12/15/2022), Scheduling Order AND ~Util - Terminate Motions. (Davis, Scott) (Entered: 09/20/2022), RESPONSE in Support re 51 MOTION to Dismiss Relator's Amended Complaint, 53 MOTION to Dismiss -- Corrected filed by United States of America. Reply. (kcv, ) (Entered: 06/09/2022), SCHEDULING ORDER granting in part the 40 MOTION to Stay Discovery. (jmv, ), E-DISCOVERY ORDER. PFIZER REVEALS CONCERNS WITH DATA INTEGRITY VINDICATING PREVIOUS CLAIMS BROOK JACKSON INTERVIEW. The BMJ investigative report has now alleged that the documentation of the clinical trials that Pfizer submitted to the FDA is brimming with data reporting errors and clinical trial misconduct. Newly released documents support whistleblower Brook Jacksons claims she was directly involved in Pfizers COVID vaccine phase 3 clinical trials, but Pfizer contractor, Ventavia Research Group, and media refuse to retract statements to the contrary. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years experience in clinical research coordination and management. To read the piece in its entirety,click here. tweet Brooke Jackson, Pfizer. Ventavia failed to report the majority of its clinical trial protocol and regulatory violations to Pfizer or the external Institutional Review Board. The FDA said, without explicitly saying it, that the allegations don't change the agency's assessment of the vaccine's safety. Under National Institutes of Health standards, a "double-blind" clinical trial is one in which neither the patient nor the person giving the medicine knows if the patient is getting a placebo or the actual drug. (Entered: 05/17/2022), ***FILED IN ERROR. They Want BP to Pay. More Than a Decade Later, Workers Battle Illness From Deepwater Horizon. One is an email with Jackson thanking Pfizers Dr. Arturo Alfaro for giving her access to the COVID-19 clinical trial software.. Paul D Thacker reports, In autumn 2020 Pfizers chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. Yet according to investigative journalist Paul D. Thacker, despite the new documented proof, Ventavia Research Group the Texas-based company Pfizer hired to conduct the pivotal trial has so far refused to retract statements the company made to the media alleging Jackson had no direct involvement. Sign up for free news and updates from Robert F. Kennedy, Jr. and Childrens Health Defense. Letter to John B Cole MD. An Interview With Ventavia and Pfizer-BioNTech COVID Vaccine Trial Whistleblower Brook Jackson 71 10 comments Sonia Elijah Author at Trial Site News | Investigative journalist and broadcaster Mar. know it, an executive stated. Like. Both confirmed broad aspects of Jacksons complaint. Brook Jackson knew things were wrong immediately after being hired in late 2020 by Ventavia Research Group. Another showed vaccine packaging materials with trial participants identification numbers written on them left out in the open, potentially unblinding participants. The U.S. Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC), and others, have failed to do their job protecting the American people. To: Ventavia Research Group & Lauren Foreman Re: Libel of Brook Jackson Demand: Retraction Lead Stories Managing Editor Dean Miller has edited daily and weekly newspapers, worked as a reporter for more than a decade and is co-author of two non-fiction books. fraud I witnessed that's now impacted hundreds of millions of lives in the United States, as well as around the world. (Entered: 06/07/2022), NOTICE of Hearing: Status Conference set for 6/9/2022 at 11:30 AM via TELEPHONE CONFERENCE (Beaumont) before District Judge Michael J. Truncale. (Entered: 03/18/2022), Unopposed Application for Extension of Time to Answer Complaint, Application Granted for Extension of Time to Answer Complaint, ***FILED IN ERROR. Your support is essential to CHDs successful mission. *** (kcv, ), Defendant's Unopposed First Application for Extension of Time to Answer Complaint re Pfizer, Inc..( Yeates, Tommy) (Main Document 22 replaced with flattened image on 3/18/2022) (kcv, ). Ive never had to do what they were asking me to do, ever, she told The BMJ. U.S. Government Plaintiff, Filing fee: $ 402, receipt number TXE100020949 (kcv, ), Unsealed by 16 OrderCOMPLAINT against SEALED 1 deft, and SEALED 2 deft, filed by SEALED pltf. Jackson, Ventavia, 2020 mRNA COVID-19 Pfizer. WebBrook Jackson, known as the COVID-19 Whistleblower, is under scrutiny over her allegations against her former employer, Ventavia Research Group (VRG), and Pfizer, RFK, Jr. & Robert DeNiro Press Conference, Subscribe to The Defender's Top News of the Day, DOE Finds COVID Likely Emerged From Wuhan Lab, Sparks Congressional Investigation, CDC Advisers Tout RSV Vaccines as FDA Admits Shots Linked to Rare Immune Disorder in Older Adults, EPA Still Hasnt Studied How Pesticides Disrupt Human Hormones 27 Years After Congress Demanded It. Actions were taken to correct and remediate where necessary. A whistleblower by the name of Brook Jackson brought some damning facts about Pfizer's COVID vaccine trial in front of the world in her explosive report on Wednesday, November 3. 30 Days Granted for Deadline Extension. A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. FDA spokesperson Alison Hunt wrote in a November 10, 2021, email to Lead Stories that the FDA still declares that the benefits outweigh risks that come with Pfizer's vaccine. On Twitter, Jackson does not express unreserved support for COVID vaccines. Hunt wrote: Although the agency cannot comment further at this time in this ongoing matter, FDA has full confidence in the data that were used to support the Pfizer-BioNTech COVID-19 Vaccine authorization and the Comirnaty approval. (Mendenhall, Warner) (Additional attachment(s) added on 10/12/2022: # 1 Text of Proposed Order) (kcv, ). Jackson spent two weeks in September 2020 as a regional manager overseeing vaccine trials Pfizer contracted Ventavia Research Group to perform. A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial. PLEASE IGNORE. Michigan Student Killed by 14-Year-Old and 13-Year-Old Boys in Attempted Carjacking After Offering Them Ride to Home. It said, [I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.5. The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. Joining me today is Brook Jackson, the whistleblower who sat down with The Last American Vagabond for her first video interview on December 2, 2021, to expose serious data integrity issues during the Pfizer trial for the COVID-19 injection, and providing all the source material to prove her claims. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place. document.getElementById( "ak_js_3" ).setAttribute( "value", ( new Date() ).getTime() ); Sign up for free news and updates from Robert F. Kennedy, Jr. and Childrens Health Defense. . Brook Jackson . Targeting of Ventavia staff for reporting these types of problems. Florida Teacher Suspended After He Made White Students Act as Servants For Black Students, Who Was Abby Choi? (kcv, ) (Entered: 06/09/2022), NOTICE of Attorney Appearance by Warner Mendenhall on behalf of United States of America ex rel. In a text message sent in June the former official apologised, saying that everything that you complained about was spot on.. Bioresearch monitoring. "Shocking, actually." Final Pretrial Conference set for 3/28/2024 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. CROs work on a fee-for-service basis, and they have grown like Document # 41, Motion to Stay and Notice of Joinder do not contain the required Certificate of Conference. All signed consent forms, excluding pro se parties, should be filed electronically using the event Notice Regarding Consent to Proceed Before Magistrate Judge cc via email: pltf's atty. Her Twitter account, which was created in September 2021, includes recent posts about the BMJ report as well as others that support some elements of vaccine resistance. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants charts, accessible to blinded personnel. (kcv, ) (Entered: 02/11/2022), AMENDED COMPLAINT against All Defendants, filed by United States of America ex rel. 30 Days Granted for Deadline Extension. Tags: Another former Ventavia employee has confirmed that the company had been expecting a federal audit of its Pfizer vaccine trial - though this did not materialize, Brook Jackson repeatedly informed her superiors of poor laboratory management and patient safety and data integrity issues, Brook Jackson reported her concerns to the US A regional director with Ventavia Research Group told The BMJ Pfizer falsified data, unblinded patients, employed inadequately trained vaccinators and was slow to follow up on adverse events reported in Pfizers pivotal COVID Vaccine phase 3 trial. A regional director who was employed at the research organization Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators and was slow to follow up on adverse events reported in Pfizers pivotal phase 3 trial. In the 20 years that I have been involved in clinical research, I have never seen a study conducted by an investigative site, managed by a contractor, or overseen by a pharmaceutical sponsor that scared me, until then. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizers pivotal phase III trial. Signed by District Judge Michael J. Truncale on 4/22/2022. Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. Jackson also raised suspicions on the 'selection of Ventavia' to quickly ramp up Pfizer's COVID vaccine trial. ( Davis, Scott) Modified title on 4/11/2022 (kcv, ). On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Clicking on the document, it appears to be an internal Ventavia email welcoming a Brook Jackson and adding her to the team working on the Pfizer trial. (Anderson, Lexis) (Entered: 03/01/2022), SUMMONS Returned Executed by United States of America ex rel. Install RECAP One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. 31:3730 Qui Tam False Claims Act, Nature of Suit: . Ventavia fired her later the same day. Login for free View subscription options Monthly donors can create unlimited docket alerts. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizers pivotal phase III trial. *** (bjc, ), PLEASE IGNORE Notice of Docket Correction regarding Doc# 37 motion to dismiss. Michael Joseph Truncale, Date of Last Known Filing: (Attachments: # 1 Text of Proposed Order Proposed Order Granting Motion and Setting Dates)(Mendenhall, Warner) (Entered: 07/29/2022), Motion for Extension of Time to File Response/Reply, ORDER granting the 60 Unopposed Motion to Amend BriefingSchedule and Other Deadlines. Pfizer had offloaded the clinical trial work onto what is known as a Contract Research Organisation (CRO). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. The claims were made in a November 2, 2021, article on the BMJ blog titled "Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial" (archived here), which opened: Users on social media only saw this title, description and thumbnail: Revelations of poor practices at a contract research company helping to carry out Pfizer's pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. pic.twitter.com/VtqDLWTCo9. The FDAs inspection officer noted: The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug]., In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. 376 Qui Tam (31 U.S.C. fabrication and falsification of blood draw information, vital signs, signatures and other essential clinical trial data; enrollment and injection of ineligible clinical trial participants, including Ventavia employees family members; failure to timely remove ineligible patients data from the trial; failure to maintain temperature control for the vaccine at issue; failure to monitor patients after injection as required by the trial protocol; principal investigator oversight failures; use of unqualified and untrained personnel as vaccinators and laboratory personnel; failure to maintain the blind as required, which is essential to the credibility and validity of the observer-blinded clinical trial; ethical violations, such as failure to secure informed consent and giving patients unapproved compensation; improper injection of the vaccine (i.e., by over-diluting vaccine concentrate or using the wrong needle size); failure to ensure that trial site staff were properly trained as required by good clinical practices; safety and confidentiality issues, including HIPAA violations; and. 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