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G3P : good privacy protection practice in clinical research : principles of pseudonymization and anonymization / / Karl-Heinz Schriever, Markus Schröder
| G3P : good privacy protection practice in clinical research : principles of pseudonymization and anonymization / / Karl-Heinz Schriever, Markus Schröder |
| Autore | Schriever K.-H. <1948-> |
| Pubbl/distr/stampa | Berlin ; ; New York : , : De Gruyter, , [2014] |
| Descrizione fisica | 1 online resource (210 p.) |
| Disciplina | 610.72/4 |
| Soggetto topico |
Clinical trials - Research
Data protection Medical care - Research Medical records - Access control Privacy, Right of |
| Soggetto genere / forma | Electronic books. |
| ISBN |
3-11-028328-X
3-11-038159-1 |
| Classificazione | PZ 4700 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Study modes -- Protection masks and procedures -- Coding methods for de-identified samples/data -- Relationships among the protection masks -- Data types -- Anonymization -- Validation : a brief introduction -- Request management -- Legal requirements & regulations -- Informed consent -- Selected data protection & medical sites -- Impact of external services on data protection -- Practical approach to clinical trials with supplementary genetic parts. |
| Record Nr. | UNINA-9910464757603321 |
Schriever K.-H. <1948->
|
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| Berlin ; ; New York : , : De Gruyter, , [2014] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
G3P : good privacy protection practice in clinical research : principles of pseudonymization and anonymization / / Karl-Heinz Schriever, Markus Schröder
| G3P : good privacy protection practice in clinical research : principles of pseudonymization and anonymization / / Karl-Heinz Schriever, Markus Schröder |
| Autore | Schriever K.-H. <1948-> |
| Pubbl/distr/stampa | Berlin ; ; New York : , : De Gruyter, , [2014] |
| Descrizione fisica | 1 online resource (210 p.) |
| Disciplina | 610.72/4 |
| Soggetto topico |
Clinical trials - Research
Data protection Medical care - Research Medical records - Access control Privacy, Right of |
| ISBN |
3-11-028328-X
3-11-038159-1 |
| Classificazione | PZ 4700 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Study modes -- Protection masks and procedures -- Coding methods for de-identified samples/data -- Relationships among the protection masks -- Data types -- Anonymization -- Validation : a brief introduction -- Request management -- Legal requirements & regulations -- Informed consent -- Selected data protection & medical sites -- Impact of external services on data protection -- Practical approach to clinical trials with supplementary genetic parts. |
| Record Nr. | UNINA-9910788828903321 |
|
Schriever K.-H. <1948->
|
||
| Berlin ; ; New York : , : De Gruyter, , [2014] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
G3P : good privacy protection practice in clinical research : principles of pseudonymization and anonymization / / Karl-Heinz Schriever, Markus Schröder
| G3P : good privacy protection practice in clinical research : principles of pseudonymization and anonymization / / Karl-Heinz Schriever, Markus Schröder |
| Autore | Schriever K.-H. <1948-> |
| Pubbl/distr/stampa | Berlin ; ; New York : , : De Gruyter, , [2014] |
| Descrizione fisica | 1 online resource (210 p.) |
| Disciplina | 610.72/4 |
| Soggetto topico |
Clinical trials - Research
Data protection Medical care - Research Medical records - Access control Privacy, Right of |
| ISBN |
3-11-028328-X
3-11-038159-1 |
| Classificazione | PZ 4700 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Study modes -- Protection masks and procedures -- Coding methods for de-identified samples/data -- Relationships among the protection masks -- Data types -- Anonymization -- Validation : a brief introduction -- Request management -- Legal requirements & regulations -- Informed consent -- Selected data protection & medical sites -- Impact of external services on data protection -- Practical approach to clinical trials with supplementary genetic parts. |
| Record Nr. | UNINA-9910815917103321 |
|
Schriever K.-H. <1948->
|
||
| Berlin ; ; New York : , : De Gruyter, , [2014] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Methods and applications of sample size calculation and recalculation in clinical trials / / Meinhard Kieser
| Methods and applications of sample size calculation and recalculation in clinical trials / / Meinhard Kieser |
| Autore | Kieser Meinhard |
| Edizione | [1st ed. 2020.] |
| Pubbl/distr/stampa | Cham, Switzerland : , : Springer, , [2020] |
| Descrizione fisica | 1 online resource (XIV, 396 p. 126 illus.) |
| Disciplina | 615.19 |
| Collana | Springer series in pharmaceutical statistics |
| Soggetto topico |
Pharmaceutical technology
Clinical trials - Research Clinical trials - Methodology |
| ISBN | 3-030-49528-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Part I: Basics -- Chapter 1- Introduction -- Chapter 2 - Statistical test and sample size calculation -- Part II : Sample size calculation -- Chapter 3 - Comparison of two groups for normally distributed outcomes and test for difference or superiority.-Chapter 4 - Comparison of two groups for continuous and ordered categorical outcomes and test for difference or superiority -- Chapter 5 - Comparison of two groups for binary outcomes and test for difference and superiority -- Chapter 6 - Comparison of two groups for time-to-event outcomes and test for differences or superiority -- Chapter 7 - Comparison of more than two groups and test for difference -- Chapter 8 - Comparison of two groups and test for non-inferiority -- Chapter 9 - Comparison of three groups in the gold standard non-inferiority design -- Chapter 10 - Comparison of two groups for normally distributed outcomes and test for equivalence -- Chapter 11 - Multiple comparisons -- Chapter 12 - Assessment of safety -- Chapter 13 - Cluster-randomized trials -- Chapter 14 - Multi-regional trials -- Chapter 15 - Integrated planning of phase II/III drug development programs -- Chapter 16 - Simulation-based sample size calculation -- Part III: Sample size recalculation -- Chapter 17 – Background -- Part IIIA: Blinded sample size recalculation in internal pilot study designs -- Chapter 18 - Background and notation -- Chapter 19 - A general approach for controlling the type I error rate for blinded sample size recalculation.-Chapter 20 - Comparison of two groups for normally distributed outcomes and test for difference or superiority -- Chapter 21 - Comparison of two groups for binary outcomes and test for difference or superiority -- Chapter 22 - Comparison of two groups for normally distributed outcomes and test for non-inferiority -- Chapter 23 - Comparison of two groups for binary outcomes and test for non-inferiority -- Chapter 24 - Comparison of two groups for normally distributed outcomes and test for equivalence.-Chapter 25 - Regulatory and operational aspects -- Chapter 26 - Concluding remarks.-Part IIIB: Unblinded sample size recalculation in adaptive designs -- Chapter 27 - Background and notation -- Chapter 28 - Sample size recalculation based on conditional power -- Chapter 29 - Sample size recalculation by optimization -- Chapter 30 - Regulatory and operational aspects -- Chapter 31 - Concluding remarks. |
| Record Nr. | UNISA-996418192103316 |
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Kieser Meinhard
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| Cham, Switzerland : , : Springer, , [2020] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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Methods and applications of sample size calculation and recalculation in clinical trials / / Meinhard Kieser
| Methods and applications of sample size calculation and recalculation in clinical trials / / Meinhard Kieser |
| Autore | Kieser Meinhard |
| Edizione | [1st ed. 2020.] |
| Pubbl/distr/stampa | Cham, Switzerland : , : Springer, , [2020] |
| Descrizione fisica | 1 online resource (XIV, 396 p. 126 illus.) |
| Disciplina | 615.19 |
| Collana | Springer series in pharmaceutical statistics |
| Soggetto topico |
Pharmaceutical technology
Clinical trials - Research Clinical trials - Methodology |
| ISBN | 3-030-49528-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Part I: Basics -- Chapter 1- Introduction -- Chapter 2 - Statistical test and sample size calculation -- Part II : Sample size calculation -- Chapter 3 - Comparison of two groups for normally distributed outcomes and test for difference or superiority.-Chapter 4 - Comparison of two groups for continuous and ordered categorical outcomes and test for difference or superiority -- Chapter 5 - Comparison of two groups for binary outcomes and test for difference and superiority -- Chapter 6 - Comparison of two groups for time-to-event outcomes and test for differences or superiority -- Chapter 7 - Comparison of more than two groups and test for difference -- Chapter 8 - Comparison of two groups and test for non-inferiority -- Chapter 9 - Comparison of three groups in the gold standard non-inferiority design -- Chapter 10 - Comparison of two groups for normally distributed outcomes and test for equivalence -- Chapter 11 - Multiple comparisons -- Chapter 12 - Assessment of safety -- Chapter 13 - Cluster-randomized trials -- Chapter 14 - Multi-regional trials -- Chapter 15 - Integrated planning of phase II/III drug development programs -- Chapter 16 - Simulation-based sample size calculation -- Part III: Sample size recalculation -- Chapter 17 – Background -- Part IIIA: Blinded sample size recalculation in internal pilot study designs -- Chapter 18 - Background and notation -- Chapter 19 - A general approach for controlling the type I error rate for blinded sample size recalculation.-Chapter 20 - Comparison of two groups for normally distributed outcomes and test for difference or superiority -- Chapter 21 - Comparison of two groups for binary outcomes and test for difference or superiority -- Chapter 22 - Comparison of two groups for normally distributed outcomes and test for non-inferiority -- Chapter 23 - Comparison of two groups for binary outcomes and test for non-inferiority -- Chapter 24 - Comparison of two groups for normally distributed outcomes and test for equivalence.-Chapter 25 - Regulatory and operational aspects -- Chapter 26 - Concluding remarks.-Part IIIB: Unblinded sample size recalculation in adaptive designs -- Chapter 27 - Background and notation -- Chapter 28 - Sample size recalculation based on conditional power -- Chapter 29 - Sample size recalculation by optimization -- Chapter 30 - Regulatory and operational aspects -- Chapter 31 - Concluding remarks. |
| Record Nr. | UNINA-9910484552403321 |
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Kieser Meinhard
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| Cham, Switzerland : , : Springer, , [2020] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Translating clinical trial outcomes measures : an overview / / Sergiy Tyupa, Diane Wild
| Translating clinical trial outcomes measures : an overview / / Sergiy Tyupa, Diane Wild |
| Autore | Tyupa Sergiy |
| Edizione | [First edition.] |
| Pubbl/distr/stampa | Torino, Italy : , : SEEd, , 2016 |
| Descrizione fisica | 1 online resource (87 pages) |
| Disciplina | 610.724 |
| Soggetto topico |
Clinical trials
Clinical trials - Research |
| Soggetto genere / forma | Electronic books. |
| ISBN | 88-97419-72-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910467935103321 |
|
Tyupa Sergiy
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||
| Torino, Italy : , : SEEd, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Translating clinical trial outcomes measures : an overview / / Sergiy Tyupa, Diane Wild
| Translating clinical trial outcomes measures : an overview / / Sergiy Tyupa, Diane Wild |
| Autore | Tyupa Sergiy |
| Edizione | [First edition.] |
| Pubbl/distr/stampa | Torino, Italy : , : SEEd, , 2016 |
| Descrizione fisica | 1 online resource (87 pages) |
| Disciplina | 610.724 |
| Soggetto topico |
Clinical trials
Clinical trials - Research |
| ISBN | 88-97419-72-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910795087003321 |
|
Tyupa Sergiy
|
||
| Torino, Italy : , : SEEd, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Translating clinical trial outcomes measures : an overview / / Sergiy Tyupa, Diane Wild
| Translating clinical trial outcomes measures : an overview / / Sergiy Tyupa, Diane Wild |
| Autore | Tyupa Sergiy |
| Edizione | [First edition.] |
| Pubbl/distr/stampa | Torino, Italy : , : SEEd, , 2016 |
| Descrizione fisica | 1 online resource (87 pages) |
| Disciplina | 610.724 |
| Soggetto topico |
Clinical trials
Clinical trials - Research |
| ISBN | 88-97419-72-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910821644703321 |
|
Tyupa Sergiy
|
||
| Torino, Italy : , : SEEd, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
