-
1
-
-
84921057537
-
-
MARC Research. Top 5 FDA warning letters for clinical investigators. Accessed April 23, 2012
-
MARC Research. Top 5 FDA warning letters for clinical investigators. http://www.imarcresearch.com/top-5-2012-download/. Accessed April 23, 2012.
-
-
-
-
2
-
-
84921057536
-
-
US Food and Drug Administration. Inspections, compliance, enforcement, and criminal investigations: enforcement actions, warning letter. Updated March 28, 2011. Accessed November 8, 2013
-
US Food and Drug Administration. Inspections, compliance, enforcement, and criminal investigations: enforcement actions, warning letter. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm248222.htm. Updated March 28, 2011. Accessed November 8, 2013.
-
-
-
-
3
-
-
84921057535
-
-
US Food and Drug Administration. Inspections, compliance, enforcement, and criminal investigations: enforcement actions, warning letters. Updated November 4, 2013. Accessed October 22, 2013
-
US Food and Drug Administration. Inspections, compliance, enforcement, and criminal investigations: enforcement actions, warning letters. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm. Updated November 4, 2013. Accessed October 22, 2013.
-
-
-
-
4
-
-
84921057534
-
-
Secretary’s Advisory Committee on Human Research Protections. SACHRP minutes, February 28-29, 2012. Accessed October 22, 2013
-
Secretary’s Advisory Committee on Human Research Protections. SACHRP minutes, February 28-29, 2012. http://www.hhs.gov/ohrp/sachrp/mtgings/2012%20Feb%20Mtg/meetingminutes.pdf. Accessed October 22, 2013.
-
-
-
-
5
-
-
84921057533
-
-
US Food and Drug Administration. CFR: Code of Federal Regulations Title 21. Updated April 1, 2013. Accessed October 23, 2013
-
US Food and Drug Administration. CFR: Code of Federal Regulations Title 21. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=812.150. Updated April 1, 2013. Accessed October 23, 2013.
-
-
-
-
6
-
-
84921057532
-
-
US Food and Drug Administration. Compliance program guidance manual: program 7348.811. Accessed October 23, 2013
-
US Food and Drug Administration. Compliance program guidance manual: program 7348.811. http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UCM133773.pdf. Accessed October 23, 2013.
-
-
-
-
7
-
-
84921057531
-
-
US Food and Drug Administration. Guidance for industry, investigator responsibilities: protecting the rights, safety, and welfare of study subjects. Accessed October 23, 2013
-
US Food and Drug Administration. Guidance for industry, investigator responsibilities: protecting the rights, safety, and welfare of study subjects. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf. Accessed October 23, 2013.
-
-
-
-
8
-
-
84921057530
-
-
International Standards Organization. Document 14155: clinical investigation of medical devices for human subjects—good clinical practice. Published February 1, 2011. Accessed October 23, 2013
-
International Standards Organization. Document 14155: clinical investigation of medical devices for human subjects—good clinical practice. http://www.unil.ch/webdav/site/fbm/shared/cercfbm/ISO-14155-2011.pdf. Published February 1, 2011. Accessed October 23, 2013.
-
-
-
-
9
-
-
84921057529
-
-
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. E3 guideline: structure and content of clinical study reports, questions & answers. Published July 6, 2012. Accessed October 23, 2013
-
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. E3 guideline: structure and content of clinical study reports, questions & answers. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_QAs_R1_Step4.pdf. Published July 6, 2012. Accessed October 23, 2013.
-
-
-
-
10
-
-
84921057528
-
-
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. E3 guideline: structure and content of clinical study reports. Published July 1996. Accessed October 23, 2013
-
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. E3 guideline: structure and content of clinical study reports. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129456.pdf. Published July 1996. Accessed October 23, 2013.
-
-
-
-
11
-
-
84921057527
-
-
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement. Published January 30, 2013. Accessed October 23, 2013
-
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement. http://www.spirit-statement.org/. Published January 30, 2013. Accessed October 23, 2013.
-
-
-
-
12
-
-
84921057526
-
-
Clinical Data Interchange Standards Consortium. Organizing and accelerating the clinical research process from the beginning: the CDISC protocol representation model and toolkit. Published April 2012. Accessed October 23, 2013
-
Clinical Data Interchange Standards Consortium. Organizing and accelerating the clinical research process from the beginning: the CDISC protocol representation model and toolkit. http://www.cdisc.org/stuff/contentmgr/files/0/58c41a172c8dc8863083b6ea233f1a54/misc/prm_document___april_2012fin.pdf. Published April 2012. Accessed October 23, 2013.
-
-
-
-
13
-
-
84921057525
-
Quality by design in clinical trials: a collaborative pilot with FDA [published online October 25, 2012]
-
Sprenger K,Nickerson D,Meeker-O’Connell A,Morrison BW.Quality by design in clinical trials: a collaborative pilot with FDA [published online October 25, 2012].Drug Inf J.:
-
Drug Inf J
-
-
Sprenger, K.1
Nickerson, D.2
Meeker-O’Connell, A.3
Morrison, B.W.4
-
14
-
-
84873827413
-
Clinical trials: rethinking how we ensure quality
-
Kramer MJ,Grandinetti C,Kramer JM,Morrison BW,Ball L,Sherman RE.Clinical trials: rethinking how we ensure quality.Drug Inf J. 2012;46:657
-
(2012)
Drug Inf J
, vol.46
, pp. 657
-
-
Kramer, M.J.1
Grandinetti, C.2
Kramer, J.M.3
Morrison, B.W.4
Ball, L.5
Sherman, R.E.6
-
15
-
-
84921057524
-
-
Clinical Trials Transformation Initiative. Expert meeting summary, principles document. Accessed November 6, 2013
-
Clinical Trials Transformation Initiative. Expert meeting summary, principles document. http://www.trialstransformation.org/what-we-do/investigational-plan/qbd-qrm/products. Accessed November 6, 2013.
-
-
-
-
16
-
-
84921057523
-
-
US Food and Drug Administration. Guidance for industry: oversight of clinical investigations—a risk-based approach to monitoring. Published August 2013. Accessed October 23, 2013
-
US Food and Drug Administration. Guidance for industry: oversight of clinical investigations—a risk-based approach to monitoring. http://www.fda.gov/downloads/Drugs/./Guidances/UCM269919.pdf. Published August 2013. Accessed October 23, 2013.
-
-
-
-
17
-
-
84921057522
-
-
European Medicines Agency. Reflection paper on risk based quality management in clinical trials. Published November 18, 2013. Accessed November 28, 2013
-
European Medicines Agency. Reflection paper on risk based quality management in clinical trials. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500155491.pdf. Published November 18, 2013. Accessed November 28, 2013.
-
-
-
-
18
-
-
84921057521
-
-
National Research Council of the National Academies. The prevention and treatment of missing data in clinical trials. Published 2010. Accessed October 23, 2013
-
National Research Council of the National Academies. The prevention and treatment of missing data in clinical trials. http://www.nap.edu/openbook.php?record_id=12955&page=R1. Published 2010. Accessed October 23, 2013.
-
-
-
-
19
-
-
84921057520
-
-
European Medicines Agency. Guideline on missing data in confirmatory clinical trials. Published July 2, 2010. Accessed November 15, 2013
-
European Medicines Agency. Guideline on missing data in confirmatory clinical trials. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500096793.pdf. Published July 2, 2010. Accessed November 15, 2013.
-
-
-
-
20
-
-
84921057519
-
-
European Medicines Agency. Home, regulatory, human medicines, inspections, GCP compliance, Q&A, GCP matters, response to question 1. Accessed October 23, 2013
-
European Medicines Agency. Home, regulatory, human medicines, inspections, GCP compliance, Q&A, GCP matters, response to question 1. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000016.jsp&mid=WC0b01ac05800296c5. Accessed October 23, 2013.
-
-
-
-
21
-
-
84921065211
-
-
Federal Register. 2009;74 (153): 40211
-
(2009)
Federal Register
, vol.74
, Issue.153
, pp. 40211
-
-
-
22
-
-
84921057518
-
-
European Medicines Agency. Reflection paper on risk based quality management in clinical trials. Published November 18, 2013. Accessed November 28, 2013
-
European Medicines Agency. Reflection paper on risk based quality management in clinical trials. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/11/WC500155491.pdf. Published November 18, 2013. Accessed November 28, 2013.
-
-
-
-
23
-
-
84921057517
-
-
European Medicines Agency. Procedure for reporting of GCP inspections requested by the Committee for Medicinal Products for Human Use (CHMP). Published March 18, 2013. Accessed November 15, 2013
-
European Medicines Agency. Procedure for reporting of GCP inspections requested by the Committee for Medicinal Products for Human Use (CHMP). http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004479.pdf. Published March 18, 2013. Accessed November 15, 2013.
-
-
-
-
24
-
-
84921057516
-
-
Medicines and Healthcare Products Regulatory Agency. Guidance for the notification of serious breaches of GCP or the trial protocol, version 4 (Final 291013). Published October 29, 2013. Accessed November 15, 2013
-
Medicines and Healthcare Products Regulatory Agency. Guidance for the notification of serious breaches of GCP or the trial protocol, version 4 (Final 291013). http://www.mhra.gov.uk/home/groups/is-insp/documents/websiteresources/con060111.pdf. Published October 29, 2013. Accessed November 15, 2013.
-
-
-
-
25
-
-
84921057515
-
-
Danish Health and Medicines Authority. Notification of serious or repeated non-compliance with good clinical practice in clinical trials. Published August 25, 2010. Updated April 20, 2012. Accessed November 15, 2013
-
Danish Health and Medicines Authority. Notification of serious or repeated non-compliance with good clinical practice in clinical trials. http://sundhedsstyrelsen.dk/en/medicines/regulation/clinical-trials/inspection-of-clinical-trials-gcp-inspection/notification-of-serious-or-repeated-non-compliance. Published August 25, 2010. Updated April 20, 2012. Accessed November 15, 2013.
-
-
-
|