Clinical Trials

12
Aug

Report of Findings for the Dan Markingson Case

OFFICE OF THE LEGISLATIVE AUDITOR STATE OF MINNESOTA A Clinical Drug Study at the University of Minnesota, Department of Psychiatry The Dan Markingson Case Special Review March 19, 2015 Members of the Legislative Audit Commission: The Office of the Legislative Auditor conducted a review of the Dan Markingson case at the request of the chairs of the House and Senate Higher Education

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19
Jul

Special 510ks Cleared with Clinical Trials

Understanding FDA Special 510(k)s with Awareness Regulatory Requirements for Special 510(k)s Under section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), there are three types of 510(k)s (traditional, abbreviated and special). Under 21 CFR 807, device modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements as well as design control requirements under the Quality

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25
Mar

State of Minnesota Findings for the Dan Markingson Case

OFFICE OF THE LEGISLATIVE AUDITOR STATE OF MINNESOTA A Clinical Drug Study at the University of Minnesota, Department of Psychiatry The Dan Markingson Case Special Review March 19, 2015 Members of the Legislative Audit Commission: The Office of the Legislative Auditor conducted a review of the Dan Markingson case at the request of the chairs of the House and Senate Higher Education

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15
Jul

FDA Draft Guidance Issued for Informed Consent Information Sheet Guidance for IRBs, CIs and Sponsors

FDA Draft Information Sheet Guidance on Informed Consent By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) and Updated on December 24, 2014 July 2014 This draft guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. This guidance is intended to provide information to

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25
Apr

Trial Master File (TMF): Good Practices and TMF SOPs

Trial Master File (TMF): Good Practices and TMF SOPs The TMF is required for firms who are subject to 2001/20/EC Article 15(5) in EU and should be helpful for those who are subject to 21 CFR Part 312 in the US. What is a Trial Master File (TMF)? A TMF is the collection of documentation that allows the conduct of

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3
Nov

Oncology Clinical Trials: Design of Phase III Clinical Trials

Oncology Clinical Trials: Design of Phase III Clinical Trials By Stephen George A phase III clinical trial is a randomized prospective controlled study designed to compare the efficacy of two or more regimens for the treatment of a specified disease or medical condition. These trials employ accepted scientific principles of good experimental design including, among other things, specification of eligibility criteria (types of patients appropriate for study), explicit

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5
Oct

Requesting a Waiver of IRB Requirements

FDA Guidance Information Sheet Guidance For Sponsors, Clinical Investigators, and IRBs Waiver of IRB Requirements for Drug and Biological Product Studies This guidance is for drug and biological product studies.  January 2006; Updated on October 2017 INTRODUCTION This guidance is intended to provide information for sponsors and sponsor-investigators about requesting a waiver of Institutional Review Board (IRB) requirements for drug and

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26
Sep

EU Clinical Trials Register Clinical Trial Database EudraCT

EU Clinical Trials Register | Clinical Trial Database (EudraCT) By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) The EU Clinical Trials Register provides public access to information from the European Union (EU) clinical trial database (EudraCT). It forms part of EudraPharm, the EU database of authorised medicinal products. The EU Clinical Trials Register gives users the possibility to search for information on

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8
Aug

Oversight of Clinical Investigations A Risk-Based Approach to Monitoring

FDA Guidance for Industry on Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the

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