IND Application Date Sponsor-Investigator Name.Investigational New Drug Application.Regulatory Sponsor: Name of the Sponsor-Investigator.Department Name Address.Funding Sponsor: Name of Primary Funding Institution Address.Study Product: Study Drug Name Generic, followed by marketed name if
PRE-STUDY SITE SELECTION VISIT CHECKLIST ______
Institute of Medicine- Committee on Conflict of Interest in Medical Research, Education, and Practice.The AAOS Office of Government Relations has prepared a brief summary of the report and a list of the IOM recommendations. The IOM report is over 300
Deans UPDATE to PRA Determination Criteria 4/2015.Prospective reimbursement analysis (PRA) development is an integral process supporting our clinical research teams. The analysis for each study results in a determination of whether charges for patients
Name of Project.PI Telephone Number.PI Email Address.VI. Box Below For IRB Use Only.Page 1 of 5 Investigational Device Form
UNMC PROCEDURES.NIH PUBLIC ACCESS POLICY.NIH Policy: As of federal FY2008, NIH-funded investigators are required to submit the final, peer reviewed manuscript of articles accepted for publication to PubMed Central (PMC). The manuscript or other
SAMPLE CONSENT FOR RESEARCH STUDY.Note: ACRIN does not monitor compliance with the Health Insurance Portability and Accountability Act (HIPAA); that is the responsibility of local IRBs. Local IRBs may choose to combine the authorization elements in the
2008-09 SPM 200 Clinical Forums: Health Promotion/Disease Prevention.Fall Semester.Test Interpretation Part 1 (DiCarlo).Introduction: Screening Module (DiCarlo).Intro to Biostatistics - Part 1 (DiCarlo).Introduction: Fuel Module (Sothern).Intro to Biostatistics - Part 2 (DiCarlo)
Assigned by IBC.Biological Materials and.Recombinant DNA Registration.UNIVERSITY OF WISCONSIN-LA CROSSE.Institutional Biosafety Committee.Return completed form to.College of Science and Health.105 Graff Main Hall, 785-8218.Title: Campus Addr.Phone: Email Addr.Laboratory Personnel.Project title
CLINICAL TRIAL OUTLINE APPLICATION.STUDY SYNOPSIS.Response to reviewers comments on a previous version of this trial.1.1 Prevalence, incidence, mortality.1.2 Burden of the disease.1.3 Improvement of therapy / impact of the trial.1.4 Patient INvolvement.3. JUSTIFICATION OF DESIGN ASPECTS
Biosensors DES Demonstrates Equivalent Safety and Efficacy to Industry Leading DES in First Real World, All Comers Clinical Study.2 October 2008 According to data published in this week s Lancet, a Biosensors-developed drug-eluting stent (DES) with
UVa Clinical Trials Website Posting.Directions for use of this template.1. Save this template to your computer.2. Insert information specific for your study where the form says to insert.3. Delete all parenthesis and text that does not apply to your study.4. Save the ad to your computer
NIH eRA Small Business Funding Opportunities (eRA-SBIR).RFA NUMBER: RR-02-XXXX.National Institutes of Health.National Center for Research Resources.Public Briefing Date.Letter of Intent Date.Application Receipt Date
NEWTON-WELLESLEY HOSPITAL.NEWTON, MASSACHUSETTS.EFFECTIVE DATE: POLICY TYPE: ADMIN.INVESTIGATIONAL DRUG POLICY.PURPOSE: The purpose of this policy is to assist in protecting patients from potential harm and ensuring the rights of patients undergoing clinical
GENE TRANSFER THERAPY IN HUMAN RESEARCH STUDIES.All studies involving the deliberate transfer of DNA, or DNA or RNA derived from recombinant DNA (human gene transfer) are subject to special submission, review, and reporting requirements at both the Federal
LOCAL IMPLEMENTATION PLAN (LIP).*Fill in header information.This form is required for new study submissions; it should be submitted with the Institutional Review Board (IRB) Institute of Translational Health Sciences (ITHS) Application and any relevant Supplements