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CTSA Institution

University of Chicago

Disclaimer Please cite the appropriate authors/contacts when using or adapting these materials.
Acknowledgment Lainie Freidman Ross, M.D., Ph.D., Carolyn and Matthew Bucksbaum Professor of Clinical Ethics
Professor, Departments of Pediatrics, Medicine and Surgery
Associate Director, MacLean Center for Clinical Medical Ethics
Co-director of the Clinical Translational Science Award
University of Chicago
Contacts Pamela F. Gonzalez, RN, MSN
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Materials Provided

Title Learning Objectives (11 Clinical Research Topic Areas)
Topics Description This is a list of eleven Clinical Research topics with the learning objectives clearly stated. These ‘Learning Objectives’ can be used to develop a comprehensive curriculum that identifies the key areas of knowledge that will ensure data integrity and institutional compliance for all staff involved in clinical research studies. The eleven topics covered are: Protocol; Study Management; Research Background; Institutional Review Board; Informed Consent; Budgets & Contracts; Research Billing; Documentation & Research Sample Processing; Adverse Events; Medical Devices; Audits & Monitoring; Blood Pressure Measurement.

Comments: Comprehensive list which can be used to develop a curriculum that will address all the fundamentals of conducting Clinical Research studies.
Keywords Adverse Event (AE); Approval of Early and Expanded Use of Devices; Auditing; Belmont Report; Brachial Artery; Budgeting; Case Report Form (CRF); Category A and Category B Medical Devices; Class I, II and III Medical Devices; Clinical Monitoring; Clinical Trial Budget; Close-Out Visit; Code of Federal Regulations; Contracting; Data Integrity; Data Storage (ICH-GCP Guidelines); Department of Health and Human Services (DHHS); Diastolic; Documentation; Double Dipping; Drug Accountability; Ethical Basis for the Development of IRB; FDA Form 1572; Food & Drug Administration (FDA); Good Clinical Practice Guidelines (GCP); History of Clinical Research; Institutional Review Board (IRB); International Conference on Harmonization Guidelines; International Standards; Investigational Device Exemption (IDE); Investigators Brochure; Major Protocol Deviation; Medical Devices; Minor Protocol Deviation; Monitoring; National Coverage Decision; Normal and Abnormal Measurements; Nuremberg Code; Office for Human Research Protections (OHRP); Office of Health and Human Services (OHHS); Office of Inspector General (OIG); Pre-Qualification Visit; Processing Labs; Protection for Research Subjects; Protocol; Regulations; Reporting Events; Research Governance; Research Shadow File; Role of the Investigator; Screening logs; Serious Adverse Event (SAE); Site Initiation Visit; Source Documentation; Sponsor; Standard of Care Costs; Systolic; The Belmont Report; The World Medical Association Declaration of Helsinki; Three Arteries Used to Measure Blood Pressure; Three Principals that Govern the Informed Consent Process; Three Types of FDA Audits; Types of Consents; Types of Research Reviewed by an IRB
See Also

Topic Data Acquisition Management Sharing and Ownership, Human Subjects, Other
Topic attachments
I Attachment Action Size Date Who Comment
pdfpdf Learning_Objectives-11_Research_Topics-University_of_Chicago.pdf manage 72.2 K 27 May 2009 - 18:37 NancyHills Comprehensive list which can be used to develop a curriculum that will address all the fundamentals of conducting Clinical Research studies.
Topic revision: r4 - 30 Mar 2010 - 19:07:43 - MaryBanach
ResearchEthics.Learning_Objectives_11_Clinical_Research_Topic_Areas moved from ResearchEthics.LearningObjectives11ClinicalResearchTopicAreas on 02 Jun 2009 - 00:02 by CTSpediaAdmin - put it back
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