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CTSA Institution

Oregon Health & Sciences University

Disclaimer Please cite the appropriate authors/contacts when using or adapting these materials.
Acknowledgment Oregon Health & Sciences University, Oregon Clinical + Translational Research Institute (OCTRI), OHSU Cancer Institute / Phyllis Carello, CCRC; Bridget Adams, MSHS, CCRA; Susan Peterson, RN
Contacts Kathryn G. Schuff, MD, Associate Professor, Endocrinology; Director, Research Support and Services
Format PowerPoint?
URL Attachment
Materials Provided PowerPoint Presentation
Title How to Analyze and Implement a Research Protocol
Topics Description This 91 slide PowerPoint presentation reviews the types of research mechanisms that are part of protocol development, such as companies (Pharmaceuticals, Biotech, Medical Device); Federal (NIH, DOD, DOE, VA); Foundations, Departmental, Investigator Initiated. It explains what a protocol is, and how to develop a protocol. Further it covers the role the IRB plays to insure the science is sound, feasible, safe, and addresses the investigator questions (i.e., do we have the facilities and resources needed to conduct the study; and is the science feasible). This presentation defines all the study phases (i.e., Phase I, Phase II, Phase III, and Phase IV) and the different types study design (i.e., Double blind; Single blind, Unblind, Parallel design, Cross-over design, Open label extension study, Observational study). The elements of a protocol are explained (i.e., Research, Design, and Methods). The presentation covers all aspects of conducting a research study once all the stages are complete (i.e., funded grant, signed contract, approved IRB, training research personnel, running the study). To summarize, this is an outstanding presentation presented in a clear and concise method.

Comments: Outstanding presentation covering every aspect of “How to Analyze and Implement a Research Protocol.”
Keywords Adverse Events; Advertising; Aim; Analyze; Background Rational; Behavioral; Biotech Company; Budget; Commercial Manufacturer; Contract; Control; Core Competencies; Cross-over Design; Data Collection; Delegation; Departmental; Design; Device Manual; DHHS; DOD; DOE; Double Blind; Duration; Educational; Enrollment; Exclusion; FDA; Foundations; Inclusion; Introduction; Investigator Drug Brochure; Investigator Initiated; IRB; IRB Approval; Lab/Operations Manual; Literature Review; Medical Device Company; Methodology; Methods; Multicenter; Multi-site Trials; NIH; Objectives; Observational Study; Open Label Extension Study; Parallel Design; Pharmaceutical Company; Phase I; Phase II; Phase III; Phase IV; Placebo; Protocol; Protocol Elements; Publication; Purposes; Randomization; Randomized; RCR Training; Research; Research Methods; Risks; Single Blind; SOPs; Standard of Care; Standard Operating Procedures; Statistical Analysis; Study Design; Subject Population; Subject Safety; Title; Training; Unblind; VA
See Also

Topic Data Acquisition Management Sharing and Ownership, Conflicts of Interest and Commitment, Human Subjects, Collaborative Science, Other
Topic revision: r8 - 30 Mar 2010 - 19:30:47 - MaryBanach
ResearchEthics.How_to_Analyze_and_Implement_a_Research_Protocol moved from ResearchEthics.How_to_Analyzeand_Implement_a_Research_Protocol on 02 Apr 2009 - 22:44 by CTSpediaAdmin - put it back
 
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