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1

L, Hammond Joseph, and Pawlikowski Krzysztof, eds. Telecommunications: Protocols and design. Reading, Mass: Addison-Wesley Pub. Co., 1991.

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2

name, No. Vaccine protocols. 2nd ed. Totowa, NJ: Humana Press, 2003.

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3

James, Carlson, ed. PPP design, implementation, and debugging. 2nd ed. Boston: Addison-Wesley, 2000.

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4

Sharp, Robin. Principles of protocol design. Berlin: Springer, 2010.

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5

Lek, Kamol. Cryptography: Protocols, design, and applications. Hauppauge, N.Y: Nova Science Publishers, 2011.

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6

Kan, Jeff WT, and John S. Gero. Quantitative Methods for Studying Design Protocols. Dordrecht: Springer Netherlands, 2017. http://dx.doi.org/10.1007/978-94-024-0984-0.

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7

Holzmann, Gerard J. Design and validation of computer protocols. London: Prentice-Hall International, 1991.

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8

OSPF network design solutions. [S.l.]: Cisco Systems, Cisco Press, 1998.

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9

Sharp, Robin. Principles of protocol design. Berlin: Springer, 2008.

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10

Delgrossi, Luca. Design of Reservation Protocols for Multimedia Communication. Boston, MA: Springer US, 1996. http://dx.doi.org/10.1007/978-1-4613-1323-6.

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11

Delgrossi, Luca. Design of Reservation Protocols for Multimedia Communication. Boston, MA: Springer US, 1996.

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12

Delgrossi, Luca. Design of reservation protocols for multimedia communication. Boston: Kluwer Academic Publishers, 1996.

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13

Enna, S. J. Short protocols in pharmacology and drug discovery: A compendium of mehods from current protocols in Pharmacology. Hoboken: J. Wiley & Sons, 2007.

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14

Brenton, Chris. Multiprotocol network design and troubleshooting. San Francisco: Sybex Network Press, 1997.

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15

Cramer, Ronald John Fitzgerald. Modular design of secure yet practical cryptographic protocols. S.l: s.n., 1997.

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16

Spohn, Darren L. Data network design. New York: McGraw-Hill, 1993.

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17

Tina, Brown, and Grau Scott, eds. Data network design. 3rd ed. New York: McGraw-Hill, 2002.

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18

Data network design. 2nd ed. New York: McGraw-Hill, 1997.

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19

Web protocols and practice: HTTP/1.1, networking protocols, caching, and traffic measurement. Boston, MA: Addison-Wesley, 2001.

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20

Yan, Zhang, and SpringerLink (Online service), eds. RFID Security: Techniques, Protocols and System-on-Chip Design. Boston, MA: Springer-Verlag US, 2009.

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21

Victor, Olifer, ed. Computer networks: Principles, technologies, and protocols for network design. Hoboken, N.J: John Wiley & Sons, 2005.

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22

Thomas, Thomas M. OSPF network design solutions. 2nd ed. Indianapolis, IN: Cisco Press, 2003.

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23

Konorski, Jerzy. Distributed network protocols for anonymous stations in cooperative and noncooperative settings. Gdańsk: Wydawn. Politechniki Gdańskiej, 2006.

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24

Sivakumar, Bala. Protocols for collecting and using traffic data in bridge design. Washington, D.C: Transportation Research Board, 2011.

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25

Hill, Martin Robert. The design of robust protocols for distributed real-time systems. Birmingham: Aston University. Departmentof Electrical and Electronic Engineering and Applied Physics, 1990.

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26

Van Zyl, Llewellyn Ellardus, and Sebastiaan Rothmann, eds. Positive Psychological Intervention Design and Protocols for Multi-Cultural Contexts. Cham: Springer International Publishing, 2019. http://dx.doi.org/10.1007/978-3-030-20020-6.

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27

Ghosn, Michel, Bala Sivakumar, and Fred Moses. Protocols for Collecting and Using Traffic Data in Bridge Design. Washington, D.C.: National Academies Press, 2011. http://dx.doi.org/10.17226/14521.

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28

Morris, Stephen Brian. Design and implementation of an SNMPv2 network management system for NetWare and TCP/IP. Dublin: University College Dublin, 1997.

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29

1958-, Gomez Carlos F., ed. Protocols for elective use of life-sustaining treatments: A design guide. New York: Springer Pub. Co., 1989.

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30

Rich, Rosen, ed. Web application architecture: Principles, protocols, and practices. 2nd ed. Chichester, West Sussex, England: Wiley, 2009.

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31

Kiefer, Claudia J. Principles for the design of standard security protocols for multilevel network communications. Monterey, Calif: Naval Postgraduate School, 1989.

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32

Technologies and protocols for the future of Internet design: Reinventing the Web. Hershey, PA: Information Science Reference, 2012.

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33

Mark, Pearrow, ed. Web usability handbook. 2nd ed. Boston, Mass: Charles River Media, 2007.

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34

Parkhurst, William R. Cisco router OSPF: Design and implementation guide. New York: McGraw Hill, 1998.

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35

High-performance data network design: Design techniques and tools. Boston: Digital Press, 2002.

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36

Mouse models for drug discovery: Methods and protocols. Totowa, N.J: Humana, 2010.

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37

Gburzyński, Paweł. Protocol design for local and metropolitan area networks. Englewood Cliffs, NJ: Prentice Hall, 1996.

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38

Mao, Wenbo, Markus Jakobsson, and Helger Lipmaa. Cryptographic Protocols, Techniques for Secure Protocol Design. Pearson Education, Limited, 2008.

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39

Andrew, Robinson, Cranage Martin P, and Hudson Michael, eds. Vaccine protocols. 2nd ed. Totowa, N.J: Humana Press, 2003.

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40

BGP Design and Implementation. Cisco Press, 2003.

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41

Understanding Ldap - Design And Implementation. IBM.Com/Redbooks, 2004.

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42

Sirna Design Methods And Protocols. Humana Press, 2012.

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43

Ehud, Gazit, and Nussinov Ruth, eds. Nanostructure design: Methods and protocols. Totowa, N.J: Humana, 2008.

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44

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Clinical trial protocols: study protocol. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0015.

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This chapter defines protocols and the requirements to be considered when writing a protocol, The protocol is one of the most important documents and must be clear, concise and well written. The chapter describes the procedures before embarking on writing a protocol, who should be involved and describes all the main elements to be included. The ICH E6 guidelines give a complete list of the content of a protocol so this chapter centres on the main decisions/considerations. The main considerations are outlined in a skeleton protocol which includes for example objectives and end points, subject population, study design, study methodology, assessments and timings and statistical considerations. Once these main decisions have been made the first full draft protocol can be written by elaborating every detail and adding the administrative sections as set out in the company/institution SOPs and the ICH GCP guidelines. The process of protocol approval is described along with the requirements for protocol amendments. The additional requirements to be considered in writing protocols for healthcare studies is set out especially the ethical requirements that have to be addressed.
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45

1947-, Robinson Andrew, Farrar Graham H, and Wiblin Christopher N, eds. Vaccine protocols. Totowa, N.J: Human Press, 1996.

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46

Rational Drug Design Methods And Protocols. Humana Press, 2012.

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47

BGP Design and Implementation. Cisco Press, 2016.

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48

Gero, John S., and Jeff WT Kan. Quantitative Methods for Studying Design Protocols. Springer, 2017.

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49

Barz, Hans W., and Gregory A. Bassett. Multimedia Networks: Protocols, Design and Applications. Wiley & Sons, Incorporated, John, 2016.

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50

American Telephone and Telegraph Company., ed. Design and validation of computer protocols. Englewood Cliffs, N.J: Prentice Hall, 1991.

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