Development and implementation of clinical trial protocol templates at the National Institute of Allergy and Infectious Diseases

Clinical Trials

Volumn 6, Issue 4, 2009, Pages 386-391

  Bridge, Heather ^a   Smolskis, Mary ^a   Bianchine, Peter ^a   Dixon, Dennis O ^a   Kelly, Grace ^a   Herpin, Betsey ^a   Tavel, Jorge ^a,b   Barron, Karyl ^b   Enama, Mary ^b   Gorman, Richard ^b   Hafner, Richard ^b   Lane, H Clifford ^b   McNamara, James ^b   Mowatt, Michael ^b   Ramsey Ewing, Anna ^b   Shorer, Shy ^b  

^a NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^b NIH/NIAID/DCR ^*

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; ACCURACY; ADVISORY COMMITTEE; ALGORITHM; ALLERGY; ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL TRIAL; HUMAN; INFECTION; INFORMATION DISSEMINATION; INTERNET; POLICY; PRACTICE GUIDELINE; PRIORITY JOURNAL; CLINICAL TRIAL (TOPIC); FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; NATIONAL HEALTH ORGANIZATION; PROCEDURES; STANDARDS; UNITED STATES;

CLINICAL PROTOCOLS; CLINICAL TRIALS AS TOPIC; GOVERNMENT REGULATION; HUMANS; NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (U.S.); UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 70449723057     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774509341482     Document Type: Article

References (11)

1. National Institute of Allergy and Infectious Diseases, Trans NIAID Clinical Research Toolkit. Available at: http://www.3.niaid.nih.gov/ research/resources/toolkit/ (accessed 12 March 2009).
2. Department of Health and Human Services, Office of Human Research Protections. Available at: www.hhs.gov/ohrp/humansubjects/guidance/ 45cfr46.htm (accessed 12 March 2009).
3. US Food and Drug Administration, Center for Drug Evaluation and Research. Available at: http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfcfr/cfrsearch.cfm (accessed 22 June 2009).
4. Treweek S., McCormack K., Abalos E. et al. PRACTIHC Collaboration. The Trial Protocol Tool: The PRACTIHC software tool that supported the writing of protocols for pragmatic randomized controlled trials. J Clin Epidemiol 2006; 59: 1127-33.
5. National Institute of Allergy and Infectious Diseases. Clinical Trials Protocol Templates. Available at: http://www.3.niaid.nih.gov/research/ resources/toolkit/protocol/ (accessed 12 March 2009).
6. Van-Tull B., Houston C., Wilson R. et al. The development and implementation of a standard template for all Institutional Review Board (IRB) protocols at a comprehensive cancer center; Abstract presentation Society for Clinical Trials 1999. Available at: http://www.sctweb.org/ abstracts/abstracts1999/abs30.pdf (accessed 03 December 2009).
7. Rozich JD, Howard RJ, Justeson JM et al. Standardization as a mechanism to improve safety in health care. Jt Comm J Qual Patient Saf 2004; 1: 5-14.
8. International Conference on Harmonisation Efficacy 6 Guideline for Good Clinical Practice. Available at: http://www.ich.org/cache/compo/ 276-254-1.html, (accessed 12 March 2009).
9. National Institute of Allergy and Infectious Diseases, DMID Clinical Research Policies and Standard Procedure Documents, DMID Interventional Protocol Template. Available at: http://www.3.niaid.nih.gov/research/ resources/DMIDClinRsrch/protdev.htm, (accessed 12 March 2009).
10. Department of Health and Human Services, Office of Human Research Protections. Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events. Available at: http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm, (accessed 12 March 2009).
11. US Food and Drug Administration, Draft Guidance for Clinical Investigators, Sponsors and IRBs Adverse Event Reporting - Improving Human Subject Protection. Available at: http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079753.pdf (accessed 22 June 2009).