Abstract
The purpose of a protocol is to define the objectives, population, study design, procedures, outcome variables, and ethical conduct of product testing. Writing a protocol is a team effort, requiring cross-functional expertise, generally from clinical development, medical affairs, regulatory affairs, and statistics; health economics may be involved also. The process of writing a protocol involves a good deal of team interaction and negotiation to reach consensus. This chapter offers suggestions for the organization and content of protocols, while fully acknowledging that the team effort required to develop a protocol may result in a document that deviates from these suggestions. An example of a protocol outline is given in Appendix II.
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References
ICH E6, Guidance for Industry, Good Clinical Practice: Consolidated Guidance, April 1996. http://www.fda.gov/cder/guidance/959fnl_OnlinePDF.pdf. (Accessed 5 March 2008).
Title 21 — Food and Drugs Chapter I — Food and Drug Administration Department of Health and Human Services Subpart B — Labeling Requirements for Prescription Drugs and/or Insulin. Sec. 201.56 Requirements on content and format of labeling for human prescription drug and biological products, April 1, 2007. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.56 (Accessed 9 March 2008.)
National Cancer Institute, US National Institutes of Health. What is randomization? http://www.cancer.gov. (Accessed 5 March 2008).
Title 21 — Food and Drugs Chapter I — Food and Drug Administration Department of Health and Human Services Subpart D — Drugs Responsibilities of Sponsors and Investigators. §312.50 General responsibilities of sponsors, April 1, 2007. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=312&showFR=l&subpartNode=21:5.0.1.1.3.4. (Accessed 9 March 2008).
Title 21 — Food and Drugs Chapter I — Food and Drug Administration Department of Health and Human Services. Subpart D — Drugs for Human Use. §312.30 Protocol Amendments. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.30. (Accessed 9 March 2008).
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© 2009 Birkhäuser Verlag Basel/Switzerland
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Wood, L.F. (2009). Protocols. In: Wood, L.F., Foote, M. (eds) Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics. Birkhäuser, Basel. https://doi.org/10.1007/978-3-7643-8362-6_5
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DOI: https://doi.org/10.1007/978-3-7643-8362-6_5
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