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| CTSA Institution |
The University of Texas Health Science Center at San Antonio |
| Disclaimer | Please cite the appropriate authors/contacts when using or adapting these materials. |
| Acknowledgment |
The University of Texas Health Science Center at San Antonio Sponsored by the Vice President for Research and Office of Clinical Research |
| Contacts | Jenice N. Longfield, M.D., M.P.H. |
| Format | |
| URL | Download |
| Materials Provided | PDF (146 pages) 1-Day “Conducting Clinical Research” Training Course Manual |
| Title | Conducting Clinical Research |
| Topics Description |
This is a one-day training course for investigators, research nurses, research coordinators and research staff with a basic, “how-to-do-it” approach to clinical trials. The format is PowerPoint? slides covering the topics of: Regulatory Practice, Key Definitions, History of Research Ethics, Investigator Responsibility, Conducting Clinical Trials, Industry Monitoring Audits and Compliance Reviews, Research Scope of Practice for Research Personnel, Informed Consent, Data Safety Monitoring, Data Integrity, Essential Regulatory Documentation, Drug Accountability, Adverse Events. Comments: "Conducting Clinical Research" Nov. 13, 2008 1-Day training course - 146 pages of PowerPoint? presentation slides compiled for trainees to use to follow along with the lectures. |
| Keywords | Adverse Events; Amendments; Archival; Assent; Audits; Belmont Report; Beneficence; Billing; Budgets; Class I; Class II; Class III; Clinical Trial; Compliance; Contract; Data Safety Monitoring Board (DSMB); Data Safety Monitoring Plan (DSMP); Device Trials; Dispensing; Documentation; Drug Accountability; Ellen Roche; FDA; FDA Audit; Good Clinical Practice (GCP); Grant; Helsinki Declaration; History; Human Subjects; Informed Consent; Investigator; IRB; Jesse Gelsinger; Justice; Modifications; Monitoring; Nazi Germany; NIH; OHRP; Pharmacologic; Phase I; Phase II; Phase III; Principal Investigator; Protocol; Regulatory; Research; Research Pharmacy; Respect for Persons; Retention; Review Process; Standard Operating Procedures (SOPs); Storage; Study Drug; Study Monitor; The Common Rule; Tuskegee; Visits; Willowbrook |
| See Also | |
| Topic | Data Acquisition Management Sharing and Ownership, Human Subjects, Research Misconduct, Collaborative Science, Other |
| I | Attachment | Action | Size | Date | Who | Comment |
|---|---|---|---|---|---|---|
 pdf |
Conducting_Clinical_Research_Nov_13_2008_book_Nov_4_noon-Longfield-1-16-09.pdf | manage | 3439.1 K | 05 May 2009 - 15:06 | NancyHills |
Topic revision: r7 - 30 Mar 2010 - 17:57:35 - MaryBanach
ResearchEthics.Conducting_Clinical_Research moved from ResearchEthics.ConductingClinicalResearch on 19 May 2009 - 22:52 by CTSpediaAdmin - put it back
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