POSITION PURPOSE.The Head of Clinical Trial Programs (the Head) is primarily accountable for delivering the Victorian Comprehensive Cancer Centre (VCCC) cancer clinical trials strategy which aims to increase the number of cancer patients on trials across VCCC partners and Victoria
Progressive MS Alliance.Scientific Steering Committee lay member ______.The Progressive MS Alliance was initially established in 2011 as the International Progressive MS Collaborative. The mission of the PMSA is to expedite the development of therapies
NUS Institutional Review Board (IRB).GUIDELINES ON HUMAN BIOMEDICAL RESEARCH.ETHICAL REVIEW OF RESEARCH USING COMMERCIALLY-AVAILABLE HUMAN BIOLOGICAL MATERIALS (EXCLUDING HUMAN TISSUES) AND CELL LINES VIA E-DECLARATION
HOW LONG SHOULD A PATIENT INFORMATION SHEET BE FOR A CLINICAL RESEARCH STUDY?.Carlito Adan1, Leela Goldstein1, Iain C Macdougall1.1Renal Unit, King s College Hospital, London.BACKGROUND: Modern-day conduct of clinical research requires a number of important
Clinical Trial Registration.REGISTRATION OF CLINICAL TRIALS.The International Committee of Medical Journal Editors (ICMJE) requires, as a condition of publication, that all clinical trials be entered into a public registry before enrolling the first patient
INSTITUTIONAL REVIEW BOARD (IRB).Application for Approval of Research Involving Humans.I certify that the information provided in this application is complete and accurate and consistent with any proposal(s) submitted to external funding agencies
Departmental Approval.Please attach the following items, if applicable.Device brochure that includes the following.Description of device and its use.Reports of prior investigations with device.Proposed investigational plan.Participant selection criteria description.Monitoring procedures
Review of the Evidence.for Clinical Management of Psychostimulant Dependence.1 Aim: To identify reviews of randomised controlled trials (RCTs) of psychostimulant treatment and summarise the findings for CERGA
Medical Devices/ Investigator Checklist.Protocol title.Medical Device/IDE effective 3/16/16 rev 8/23/17
Department of Defense.Human Research Protection Program.DoD Institutional Agreement.for Institutional Review Board (IRB) review.Name of Institution A relying on and supplying the IRB Services.Name of Institution B relying on and supplying the IRB Services.Institution Information
QIBA DWI Profile v1.09.I. Clinical context.a. Gain insight into microstructure and composition in tumors using precise measurements of ADC for robust tissue characterization and longitudinal tumor monitoring
iNSERT tITLE OF THE PROTOCOL.Include phase (e.g. phase I, phase II, etc.), design (e.g. randomized, double blind, placebo controlled, etc), if the study is multi-centered , the investigational drug or device , and target disease(s ).Example title
Effective April 14, 2015, the NIH instituted a new online application system for initial Certificates of Confidentiality (CoC). All applications for CoCs must be made using the new system (i.e., hard copies no longer accepted). The following steps will
IRB External Reporting #210.The purpose of this policy is to outline the steps to be taken by AMITA Health and its Institutional Review Board (IRB) to determine if an event is reportable to federal agencies and others and, if reportable, the requirements of filing such a report
INSTITUTIONAL REVIEW BOARD.ADVERTISING FOR STUDY VOLUNTEERS.Institutional Review Boards (IRBs) are responsible for ensuring the equitable selection of research volunteers (21 CFR 56.111 (a) (3). In fulfilling this responsibility, IRBs should review the
REVIEWER CHECKLIST.Investigational Device Exemption (IDE) Determination.PROTOCOL TITLE.Principal Investigator: IRB REFERENCE.SPONSOR/FUNDING SOURCE.IRB Panel: A B Meeting Date.Reviewer Initials: Primary Reviewer.Verification of IND Status.Does the device have an IDE issued by the FDA? Yes No