Medical Research

After Launching Suitcase 8, You Will Be Requested to Serialize and Register the Software

TO: Investigators and Sponsors.FROM: Human Subjects Office.RE: IND/Outside Safety Reports under FDA Regulations for Investigational New Drugs.The University of Iowa complies with the federal regulations at 21 CFR 312.32(c) which state

1. Identify the Agent to Be Used in This Study

1. Identify the agent to be used in this study.a. Trade Name/Biologic (e.g., Tylenol).b. Generic Name (e.g., acetaminophen).c. Manufacturer (e.g., McNeil).2. Identify the regulatory status of the agent(s) to be used in this study (select one of the following options (a-d))

O Brave New Industry, That Has Such Patents in It

Blurred Boundaries: Tensions Between Open Scientific Resources and Commercial Exploitation of Knowledge in Biomedical Research *.Iain M. Cockburn.Boston University and NBER.Prepared for the Advancing Knowledge and the Knowledge Economy Conference.National Academy of Sciences

LBH IRB Guide # 16B: Expanded Access Mechanisms Page 2 of 10

D EPARTMENT OF RESEARCH.LBH IRB Guide # 16b: Expanded Access Mechanisms Page 2 of 10.Institutional Review Board.Expanded Access for an Unapproved Drug, Biologic, or Device.An unapproved test item (i.e., drug, biologic, or medical device) may only be used

Minutes of the GCP Consultative Committee Meeting 15 January 2008

Minutes of the GCP Consultative Committee Meeting 22 September 2011.MHRA, R-T-310, 3rd Floor, 151 Buckingham Palace Rd, London, SW1W 9SZ.External Attendees.Alec Deighton ACRO.Barney Horne BARQA.Carol Wilcock ABPI Clinical Research Expert Network (CREN).Colin Wilsher BARQA

Subteam: Pediatric and Small Population Drug Development

Subteam: Pediatric and Small Population Drug Development.Leader Information.Margaret Meg Gamalo (Eli Lilly & Co).Subteam Overview.We are a group of individuals from pharma, academia, and regulatory agency, within the Bayesian Scientific Working Group

Current Animal Research Topics: Doing Right by the Animals to Serve Veterans (A Conversation

A15: Current Animal Research Topics: Doing Right by the Animals to Serve Veterans (A Conversation With Track).PRIM&R 2015 IACUC Conference.What is VVC? And When Does it Come into Play? (Scenario for presentation by Alice Huang)

Member Reviewer Checklist

CHECKLIST: Investigational Drug.Instructions: Complete this checklist as you review the protocol. Records and minutes must document protocol-specific findings justifying each of the determinations.Reviewer (Print Name) Reviewer s Signature Date

Clinical Trials Pharmacist Job Description

Clinical Trials Pharmacist Job Description.The National Children s Research Centre (NCRC) is the primary paediatric research institute in Ireland, and has both a state of the art research laboratory and the Children s Clinical Research Unit at Our Lady

<Protocol Title> Version <X.X>

<Protocol Title> Version <x.x>.Protocol <#> <DD Month YYYY>.This clinical trial protocol template is a suggested format for Phase 2 and 3 clinical trials funded by the National Institutes of Health (NIH) that are being conducted

ACRIN Semi-Annual Meeting

ACRIN Fall Meeting.Research Associates Committee Agenda.Morning Session: Moderator - Lorna Beccaria, RN.09:00-09:15 Welcome and RA Committee Updates: Lorna Beccaria, RN, Wendy Smith, RT.09:15-09:45 What is an IND and How Does It Affect ACRIN Trials?: Lalitha Shankar, MD, PhD

University of Nevada, Reno s1

The University of North Carolina at Greensboro.Procedures for Human Research Protection.1.2 Ethical Principles: The Belmont Report 2.3 Institutional Authority 6.3.1 Assurance of Compliance 7.3.3 North Carolina Law 7.4 UNCG Institutional Review Board 7.4.1 Authority of the IRB 8

Aastrom News Release

Aastrom Announces Collaboration with the CPC Clinical Research for the Phase 3 REVIVE Study in Critical Limb Ischemia.ANN ARBOR, Mich., May 25, 2011 - Aastrom Biosciences, Inc. (Nasdaq: ASTM), a leading developer of patient-specific, expanded multicellular

Checklist of Information to Be Included When Reporting a Clinical Pharmacokinetic Studya

Checklist of Information to be Included When Reporting a Clinical Pharmacokinetic Studya.a Adapted from: Kanji S, Hayes M, Ling A, et al. Reporting Guidelines for Clinical Pharmacokinetic Studies: The ClinPK Statement. Clin Pharmacokinet. 2015. DOI 10.1007/s40262-015-0236-8

Documents Required

Research Collaborator (Clinical) is a non-NIH employee or trainee, employed by or associated with an outside organization, who performs clinical research or rotations at or for NIH pursuant to an agreement (e.g., individuals on a CRADA or other types of agreements)

INVEST/CTN Drug Abuse Research Fellowship

INVEST/CTN Drug Abuse Research Fellowship

INVEST/CTN Drug Abuse Research Fellowship.Annual Application Deadline: April 1.Application Instructions.In addition to the normal cohort of INVEST Fellows, the National Institute on Drug Abuse (NIDA) International Program and Clinical Trials Network (CTN)

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