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Risk-based Monitoring of Clinical Trials: An Integrative Approach
Agrafiotis, Dimitris K., Lobanov, Victor S., Farnum, Michael A., Yang, Eric, Ciervo, Joseph, Walega, Michael, Baumgart, Adam, Mackey, Aaron J.
Published in Clinical therapeutics (01.07.2018)
Published in Clinical therapeutics (01.07.2018)
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Clinical Research Coordinators’ Attitude Toward Risk-Based Monitoring
Jeong, Ihn Sook, Jeong, Jeong Hee, Hwang, Youn Sun, Youn, Ji Hyang
Published in Therapeutic innovation & regulatory science (01.09.2019)
Published in Therapeutic innovation & regulatory science (01.09.2019)
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Risk-Based Monitoring Versus Source Data Verification
Manasco, Penelope, Herbel, Eric, Bennett, Sean, Pallas, Michelle, Bedell, Lisa, Thompson, Deborah, Fielman, Kevin, Manasco, Garrett, Kimmel, Charlene, Lambeth, Everett, Danzig, Lisa
Published in Applied clinical trials (01.11.2018)
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Published in Applied clinical trials (01.11.2018)
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Quality management in risk based monitoring
Nayak, Veerabhadra Sanekal, Khan, Mohammed Saleem, Shukla, Bharat Kumar S
Published in International Journal of Clinical Trials (09.05.2016)
Published in International Journal of Clinical Trials (09.05.2016)
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Technology Considerations to Enable the Risk-Based Monitoring Methodology
Barnes, Shelly, Katta, Nareen, Sanford, Neil, Staigers, Thomas, Verish, Thomas
Published in Therapeutic innovation & regulatory science (01.09.2014)
Published in Therapeutic innovation & regulatory science (01.09.2014)
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Impact of source data verification on data quality in clinical trials: an empirical post hoc analysis of three phase 3 randomized clinical trials
Andersen, Jeppe Ragnar, Byrjalsen, Inger, Bihlet, Asger, Kalakou, Faidra, Hoeck, Hans Christian, Hansen, Gitte, Hansen, Henrik Bo, Karsdal, Morten Asser, Riis, Bente Juel
Published in British journal of clinical pharmacology (01.04.2015)
Published in British journal of clinical pharmacology (01.04.2015)
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Evaluation of Data Errors and Monitoring Activities in a Trial in Japan Using a Risk-Based Approach Including Central Monitoring and Site Risk Assessment
Kondo, Hidenobu, Kamiyoshihara, Tomoaki, Fujisawa, Kenji, Nojima, Toshiaki, Tanigawa, Ryohei, Fujiwara, Hisataka, Suganami, Hideki, Hayashi, Yukikazu, Yamaguchi, Takuhiro
Published in Therapeutic innovation & regulatory science (01.07.2021)
Published in Therapeutic innovation & regulatory science (01.07.2021)
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Predicting enrollment performance of investigational centers in phase III multi-center clinical trials
van den Bor, Rutger M., Grobbee, Diederick E., Oosterman, Bas J., Vaessen, Petrus W.J., Roes, Kit C.B.
Published in Contemporary clinical trials communications (01.09.2017)
Published in Contemporary clinical trials communications (01.09.2017)
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Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials
Sheetz, Nicole, Wilson, Brett, Benedict, Joanne, Huffman, Esther, Lawton, Andy, Travers, Mark, Nadolny, Patrick, Young, Stephen, Given, Kyle, Florin, Lawrence
Published in Therapeutic innovation & regulatory science (01.11.2014)
Published in Therapeutic innovation & regulatory science (01.11.2014)
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Statistical Monitoring in Clinical Trials: Best Practices for Detecting Data Anomalies Suggestive of Fabrication or Misconduct
Knepper, David, Lindblad, Anne S., Sharma, Gaurav, Gensler, Gary R., Manukyan, Zorayr, Matthews, Abigail G., Seifu, Yodit
Published in Therapeutic innovation & regulatory science (01.03.2016)
Published in Therapeutic innovation & regulatory science (01.03.2016)
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Xtalks Presents Webinar on Risk-Based Monitoring
Published in Health & Beauty Close - Up
(21.10.2015)
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Research and Markets Adds Report: Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing
Published in Professional Services Close - Up
(05.02.2014)
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